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Research Interests: Treatment, Chronic kidney disease, Inflammation, Erythropoietin, Humans, and 16 moreAlbumin, Female, Male, Haemodialysis, Nutritional Status, Multiple Linear Regression, Clinical Sciences, Aged, Middle Aged, C reactive protein, Body Weight, Cross sectional Study, Cross Sectional Studies, Chronic Kidney Failure, Renal Dialysis, and Serum Iron
Research Interests: Adolescent, Humans, Female, Male, Karyotyping, and 3 morePedigree, Adult, and Philadelphia Chromosome
We investigated the contribution of transfer of Ag-experienced donor T cells to the immune reconstitution of allogeneic bone marrow transplantation (BMT) recipients. To this purpose, we used a combination of cell culture methods to... more
We investigated the contribution of transfer of Ag-experienced donor T cells to the immune reconstitution of allogeneic bone marrow transplantation (BMT) recipients. To this purpose, we used a combination of cell culture methods to isolate tetanus toxoid (TT)-specific T cell clones, and a sensitive and specific heteroduplex analysis to monitor the presence of a particular clonotype using TCR N region sequences. We document that patients after BMT display a small response to TT, entirely accounted for by few donor-derived clones. These patients show a strong polyclonal response to TT vaccination; however, the T cell clones transferred with the transplant can still be detected within the polyclonal T cell lines for up to at least 5 yr after BMT. We also demonstrate that vaccination of donors with TT before BMT results in a more relevant transfer of Ag-experienced T cells, allowing the recipients to mount a strong polyclonal response without need of vaccination. These findings provide ...
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There are very few data on the molecular biology of hepatitis C virus (HCV) infection in dialysis patients. 101 patients undergoing dialysis treatment in 4 units in the Lombardy, northern Italy, were analyzed by RT-PCR for HCV viremia, by... more
There are very few data on the molecular biology of hepatitis C virus (HCV) infection in dialysis patients. 101 patients undergoing dialysis treatment in 4 units in the Lombardy, northern Italy, were analyzed by RT-PCR for HCV viremia, by line probe assay technology for HCV genotyping and by a serological analysis for detecting type-specific antibodies. 61 of 101 (60%) patients showed detectable HCV RNA in serum; HCV genotype 2a was dominant (30/53 = 57%), followed by HCV genotype 1b (20/53 = 37%). There was no relationship between HCV genotyping and the clinical or demographic features of the patients. The antibody response toward the c33-c, c100-3, and 5-1-1 antigens was more frequent in HCV genotype 1b compared with genotype 2a (p = 0.046, p = 0.001 and p = 0.0001, respectively). The antibody levels to NS-3 and NS-4 HCV proteins were significantly higher in patients with-HCV genotype 1b in comparison with HCV 2a-infected individuals (p = 0.0001). There was a high level (82%) of agreement between HCV genotyping by RT-PCR and the assessment of type-specific antibodies by serological analysis; further, it was possible to detect type-specific antibodies in 6 of 22 (27%) patients in whom PCR amplification was unsuccessful. In conclusion, HCV subtype 2a was dominant in our population of HCV-infected dialysis patients, dialysis patients infected by different genotypes showed similar demographic and clinical characteristics, the antibody response toward the NS-3- and NS-4-related antigen of HCV was genotype dependent. There was a high level of agreement between HCV genotyping by RT-PCR and the detection of type-specific antibodies by serological analysis. As significant biological differences may exist among HCV strains, the assessment of HCV types may be very useful in the routine clinical activity of nephrologists in dialysis units.
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Hepatitis C virus (HCV) infection is highly prevalent in dialysis patients. To further characterize HCV infection in this patient population, we studied the distribution of viral genotypes in 55 patients undergoing chronic dialysis... more
Hepatitis C virus (HCV) infection is highly prevalent in dialysis patients. To further characterize HCV infection in this patient population, we studied the distribution of viral genotypes in 55 patients undergoing chronic dialysis treatment with seropositivity for HCV markers. Thirty-two of 55 (58%) patients showed HCV RNA in the serum using reverse transcription polymerase chain reaction (RT-PCR) in the 5'-untranslated region (UTR) of the viral genome. HCV genotyping was performed using biotinylated type-specific oligonucleotide probes after hybridization with amplified sample material. HCV subtype 2a was dominant (56%), followed by HCV subtype 1b (31%), type 3 (3%) and 4 (3%). There was no association between demographic or clinical features of this cohort and HCV genotype. Genotype dependence was observed for antibody response toward the NS4 (c 100-3 and 5-1-1) proteins, which was infrequent in genotype 2a carriers compared with genotype 1b (p = 0.004). HCV subtype 2a was dominant in our cohort of anti-HCV-positive dialysis patients; there was no association between HCV genotypes and demographic or clinical features of patients; the absence of antibody response toward the NS4-related antigens was frequent in genotype 2a carriers and may serve to predict responses to interferon therapy. The relative homogeneity of the viral population in dialysis patients attending our unit suggests a nosocomial transmission of HCV in this clinical setting.
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We describe the case of a 19-year-old boy with acute leukaemia who developed primary hepatic zygomycosis. The patient presented with febrile neutropenia and severe abdominal tenderness. Despite the administration of antibiotics and... more
We describe the case of a 19-year-old boy with acute leukaemia who developed primary hepatic zygomycosis. The patient presented with febrile neutropenia and severe abdominal tenderness. Despite the administration of antibiotics and liposomal Amphotericin-B (L-AmB), the CT scan demonstrated an increase in the size of liver lesions. A wide surgical resection was carried out and liver specimens demonstrated a branching, filamentous fungus that was identified as Rhizomucor pusillus by both phenotypic and molecular methods. The patient was treated with L-AmB combined with posaconazole, and deferasirox was subsequently added given the potential synergistic effect of this iron chelator in combination with L-AmB. Three months after surgical intervention, an allogeneic stem-cell transplantation was successfully carried out. The present case confirms that an early surgical management combined with antifungal agents is crucial to optimise the outcome of patients with zygomycosis and the use of deferasirox is a promising alternative.
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Graft-versus-host disease (GVHD) represents one of the major complications of allogeneic bone marrow transplantation (BMT). Nevertheless, the occurrence of mild GVHD could be desirable in high-risk leukemic patients, due to a... more
Graft-versus-host disease (GVHD) represents one of the major complications of allogeneic bone marrow transplantation (BMT). Nevertheless, the occurrence of mild GVHD could be desirable in high-risk leukemic patients, due to a relapse-preventing effect known as the graft-versus-leukemia (GVL) effect. Given that different prophylactic interventions are available to prevent GVHD development, the decision problem consists in assessing both type and dosage of the drugs in order to avoid or induce GVHD, according to the specific patient's condition. The decision problem can be represented and solved by using an influence diagram. The choice of this formalism allows using new available methods for building and updating the model of the decision problem. The qualitative structure of the model and the conditional probabilities were first derived by combining literature results with a medical expert's judgement. More specifically, probabilities were initially assigned as ranges rather than as point values. Then, conditional probabilities were updated, by using a learning algorithm, as new cases became available. The authors analyzed 50 cases of pediatric patients affected by either malignant or nonmalignant diseases, undergoing BMT and receiving GVHD prophylaxis. They used the first 25 cases to adjust the initially assigned conditional probabilities, then checked the model obtained on the remaining patients. The overall performance for GVHD prediction was about 80%.
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Thirty-eight second allogeneic bone marrow transplants (BMT) for acute leukemia relapsed after first BMT were performed in 13 Italian centers between 1987 and 1994. Twenty-one patients had acute myelogenous leukemia (AML), 17 acute... more
Thirty-eight second allogeneic bone marrow transplants (BMT) for acute leukemia relapsed after first BMT were performed in 13 Italian centers between 1987 and 1994. Twenty-one patients had acute myelogenous leukemia (AML), 17 acute lymphoblastic leukemia (ALL); at second BMT 24 patients were in complete remission (CR) and 14 in relapse. The median time to relapse after first BMT was 10 months (range 1-70). Grade II or greater acute graft-versus-host disease (GVHD) after second transplant occurred in 34.2% of patients and a chronic GVHD in 31.5% of patients. Twenty-four patients died: seven from early transplant-related mortality (TRM), 13 from relapse and four from late toxicity. As of 31 July 1996, at a median follow-up of 47 months (range 22-85), there are 14 survivors. The three-year probability of TRM, relapse and event-free survival (EFS) is 28%, 40% and 42% respectively. In 20 of 27 evaluable patients, remission duration after second BMT was longer than after the first BMT. A diagnosis of AML was correlated with a better outcome. These data support the usefulness of second allograft in selected patients with AML relapsing after a first BMT.
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Research Interests: Leukemia, Adolescent, Prospective studies, Humans, Child, and 5 moreFemale, Male, Infant, Pancytopenia, and Clinical Sciences
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In the crab Chasmagnathus learning model, systemic administration of cAMP analogues that are specific activators or inhibitors of cAMP-dependent protein kinase (PKA) proved to respectively facilitate or impair long-term retention. The... more
In the crab Chasmagnathus learning model, systemic administration of cAMP analogues that are specific activators or inhibitors of cAMP-dependent protein kinase (PKA) proved to respectively facilitate or impair long-term retention. The aims of the present work were to analyse PKA activity distribution in the crab brain and to characterise PKA isoforms. The neuropils from the eyestalk showed higher levels of induced PKA activity when compared with other neuropils of the central nervous system. Two PKA isoforms, homologous to mammalian PKA I and PKA II, were detected from central brain protein extracts using DEAE chromatography. Only PKA II was found in lateral protocerebrum extracts, suggesting a role of this isoform in the processing of visual inputs and in the integration of this information with other sensory inputs. PKA I was observed to be ten-fold more sensitive to cAMP than PKA II. cGMP induced a high activation of both PKA isoforms, similar to that obtained with cAMP. PKA I showed a two-fold greater sensitivity for cGMP than PKA II. An autophosphorylation assay was performed and a protein of 55 kDa, corresponding to phosphorylated R II regulatory subunit, was detected. The presence of a PKA I isoform with high sensitivity for cAMP in the central brain suggests a role of this subtype in long-term memory.
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PURPOSE Juvenile myelomonocytic leukemia (JMML) is a rare early childhood myelodysplastic/myeloproliferative disorder characterized by an aggressive clinical course. Age and hemoglobin F percentage at diagnosis have been reported to... more
PURPOSE Juvenile myelomonocytic leukemia (JMML) is a rare early childhood myelodysplastic/myeloproliferative disorder characterized by an aggressive clinical course. Age and hemoglobin F percentage at diagnosis have been reported to predict both survival and outcome after hematopoietic stem cell transplantation (HSCT). However, no genetic markers with prognostic relevance have been identified so far. We applied gene expression-based classification to JMML samples in order to identify prognostic categories related to clinical outcome. PATIENTS AND METHODS Samples of 44 patients with JMML were available for microarray gene expression analysis. A diagnostic classification (DC) model developed for leukemia and myelodysplastic syndrome classification was used to classify the specimens and identify prognostically relevant categories. Statistical analysis was performed to determine the prognostic value of the classification and the genes identifying prognostic categories were further analyzed through R software. RESULTS The samples could be divided into two major groups: 20 specimens were classified as acute myeloid leukemia (AML) -like and 20 samples as nonAML-like. Four patients could not be assigned to a unique class. The 10-year probability of survival after diagnosis of AML-like and nonAML-like patients was significantly different (7% v 74%; P = .0005). Similarly, the 10-year event-free survival after HSCT was 6% for AML-like and 63% for nonAML-like patients (P = .0010). CONCLUSION Gene expression-based classification identifies two groups of patients with JMML with distinct prognosis outperforming all known clinical parameters in terms of prognostic relevance. Gene expression-based classification could thus be prospectively used to guide clinical/therapeutic decisions.
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Hematopoietic stem cell transplantation (HSCT) still represents the only treatment potentially able to prevent/rescue the development of marrow failure and myeloid malignancies in patients with Fanconi anemia (FA). While in the past HSCT... more
Hematopoietic stem cell transplantation (HSCT) still represents the only treatment potentially able to prevent/rescue the development of marrow failure and myeloid malignancies in patients with Fanconi anemia (FA). While in the past HSCT from an HLA-identical sibling was proven to cure many patients, a higher incidence of treatment failure has been reported in recipients of an unrelated donor (UD) or HLA-partially matched related allograft. We analyzed the outcome of 64 FA patients (age range, 2-20 years) who underwent HSCT between January 1989 and December 2005. Patients were transplanted from either an HLA-identical sibling (n=31), an UD (n=26), or an HLA-partially matched relative (n=7). T-cell depletion of the graft was performed in patients transplanted from an HLA-disparate relative. The 8-year estimate of overall survival (OS) for the whole cohort was 67%; it was 87%, 40% and 69% when the donor was an HLA-identical sibling, an UD and a mismatched relative, respectively (p<0.01). The outcome of recipients of grafts from an UD improved over time, the probability of survival being 10% and 72% for patients transplanted before and after 1998, respectively (p<0.05). The OS probability of children who did or did not receive fludarabine in preparation for the allograft was 86% and 59%, respectively (p<0.05). These data, useful for counselling, provide support to the concept that a relevant proportion of FA patients undergoing HSCT can now be successfully cured, even in the absence of an HLA-identical sibling, especially if the conditioning regimen includes fludarabine.
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Griscelli syndrome (GS) is a rare autosomal recessive disorder, characterized by pigmentary dilution of the skin and hair and in most patients by abnormal regulation of the immune system, which results in a syndrome of macrophage... more
Griscelli syndrome (GS) is a rare autosomal recessive disorder, characterized by pigmentary dilution of the skin and hair and in most patients by abnormal regulation of the immune system, which results in a syndrome of macrophage hyperactivation, known as hemophagocytic lymophohistiocytosis (HLH). Allogeneic hematopoietic stem cell transplantation (HSCT) is the only curative treatment available for genetically induced HLH. Few cases of successful HSCT from a compatible donor have been reported in children with GS. We describe the first patient with GS cured with an allograft from a compatible unrelated bone marrow donor. We used a novel preparative regimen consisting of busulfan, thiotepa and fludarabine. The demonstrated curative effect of HSCT from an unrelated donor in a patient with genetically determined HLH also supports the use of a systematic diagnostic approach in these patients, in order to identify those with a worse prognosis and needing an urgent allograft in a timely manner.
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The therapeutic options for patients with acute leukemia who relapse after the initial transplant include second bone marrow transplantation (2BMT) and conventional chemotherapy (CC). In this work, we conducted an analysis of published... more
The therapeutic options for patients with acute leukemia who relapse after the initial transplant include second bone marrow transplantation (2BMT) and conventional chemotherapy (CC). In this work, we conducted an analysis of published survival data and we evaluated the cost-effectiveness of 2BMT in comparison with CC. We retrieved survival information on 167 patients treated with 2BMT and 299 patients treated with CC. Survival figures were derived from individual patient data and were compared between 2BMT and CC. The mean lifetime survival (MLS) was estimated for each of the two patient cohorts using standard techniques of survival-curve extrapolation. The cost data of patients given 2BMT or CC were estimated from published data. Our analysis of individual survival data showed that 2BMT improved survival at levels of statistical significance (survival gain = 19.6 months per patient). Using an incremental cost of $90000 per patient, the cost-effectiveness ratio of 2BMT in comparison with CC was calculated as $52215 discounted dollars per discounted life year gained. Our results indicate that, in patients with acute leukemia who relapse after their first transplant, 2BMT significantly prolongs survival in comparison with CC and seems to have an acceptable cost-effectiveness profile.
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From January 1984 to December 1994, ABMT was performed on 154 children (101 males, 53 females; median age 10, range 3–21 years) with ALL and registered for BMT by the AIEOP (Italian Association of Paediatric Haemato-Oncology). All... more
From January 1984 to December 1994, ABMT was performed on 154 children (101 males, 53 females; median age 10, range 3–21 years) with ALL and registered for BMT by the AIEOP (Italian Association of Paediatric Haemato-Oncology). All patients were in CR: 98 were in 2nd CR and 56 were in >2nd CR. Fifteen children (9.7%) died of transplant-related mortality. Ninety-five
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MSCs are multipotent cells that can be isolated from several human tissues and expanded ex vivo for clinical use. They comprise a heterogeneous population of cells, which, through production of growth factors, cell-to-cell interactions... more
MSCs are multipotent cells that can be isolated from several human tissues and expanded ex vivo for clinical use. They comprise a heterogeneous population of cells, which, through production of growth factors, cell-to-cell interactions and secretion of matrix proteins, has a role in the regulation of hematopoiesis. In recent years, several experimental studies have shown that MSCs are endowed with immunomodulatory properties and with the capacity to promote graft survival in animal models. In view of these properties, MSCs have been tested in pilot studies aimed at preventing/treating graft rejection and at accelerating recovery after hematopoietic cell transplantation (HCT). The available clinical evidence deriving from these studies indicates that MSC infusion is safe and promising in terms of capacity of preventing graft failure. More debated is the effect of MSCs for what concerns their capacity of accelerating hematopoietic reconstitution after HCT. Whether the favorable effect of MSCs largely depends on the type of transplantation remains also a field of future investigation. Moreover, future researches should be oriented to gain more insights on MSC biological and functional mechanisms relevant for exploiting their use in the modulation of alloreactivity and in the promotion of hematopoietic reconstitution.
Research Interests: Stem Cells, Cytokines, Hematopoiesis, Humans, Mice, and 13 moreAnimals, Progenitor Cells, Animal Model, Behavioral Animal Models, Clinical Sciences, Bone Marrow Transplantation, Neoplasms, Stromal Cells, Graft Rejection, Mesenchymal Stromal Cells, Hematopoietic Cell Transplantation, Hematopoietic Stem Cell Transplantation, and Clinical Trials as Topic
Epstein-Barr virus (EBV)-associated post-transplant lymphoproliferative disease (PTLD) and adenovirus (AdV)-related pathologies are life-threatening complications of immunosuppression in recipients of hematopoietic stem cell... more
Epstein-Barr virus (EBV)-associated post-transplant lymphoproliferative disease (PTLD) and adenovirus (AdV)-related pathologies are life-threatening complications of immunosuppression in recipients of hematopoietic stem cell transplantation (HSCT). In certain cohorts (unrelated and haploidentical donor HSCT, T-cell-depleted allograft), the risk of developing these complications is higher. Here we describe the impact of T cell therapy, within programs of specific routine surveillance and preemptive treatment, on the course of EBV infection, and development of related disease, in pediatric recipients of T-cell-depleted, HLA-haploidentical HSCT. Future prospectives include the transfer of this technology to treat AdV-related complications following HSCT.
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To identify cytogenetic risk factors predicting outcome in children with advanced myelodysplastic syndrome, overall survival of 192 children prospectively enrolled in European Working Group of Myelodysplastic Syndrome in Childhood studies... more
To identify cytogenetic risk factors predicting outcome in children with advanced myelodysplastic syndrome, overall survival of 192 children prospectively enrolled in European Working Group of Myelodysplastic Syndrome in Childhood studies was evaluated with regard to karyotypic complexity. Structurally complex constitutes a new definition of complex karyotype characterized by more than or equal to 3 chromosomal aberrations, including at least one structural aberration. Five-year overall survival in patients with more than or equal to 3 clonal aberrations, which were not structurally complex, did not differ from that observed in patients with normal karyotype. Cox regression analysis revealed the presence of a monosomal and structurally complex karyotype to be strongly associated with poor prognosis (hazard ratio = 4.6, P < .01). Notably, a structurally complex karyotype without a monosomy was associated with a very short 2-year overall survival probability of only 14% (hazard ratio = 14.5; P < .01). The presence of a structurally complex karyotype was the strongest independent prognostic marker predicting poor outcome in children with advanced myelodysplastic syndrome.
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Research Interests: Humans, Female, Blood, Male, Follow-up studies, and 16 moreBone marrow, Recurrence, Clinical Sciences, Aged, Middle Aged, Adult, Time Factors, Tumor Necrosis Factor–α (TNF), Antineoplastic Agents, MINIMAL RESIDUAL DISEASE, Benzamides, Acute Lymphoblastic Leukemia, Bone Marrow Cells, Cytotoxic T cells, Interleukin, and Interferon gamma
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Research Interests: Treatment Outcome, Adolescent, Stem Cell, Hematopoiesis, Acute Myeloid Leukemia, and 16 moreHumans, Child, Female, Blood, Male, Infant, Follow-up studies, Recurrence, Clinical Sciences, Neutrophils, Analysis of Variance, Survival Rate, Retrospective Studies, Prospective Study, Bone Marrow Cells, and Hematopoietic Stem Cell Transplantation
Research Interests: Survival Analysis, Treatment Outcome, Adolescent, Ovarian Cancer, Humans, and 20 moreChild, Female, Blood, Male, Infant, Incidence, Risk factors, Clinical Sciences, Aged, Middle Aged, Adult, Retrospective Studies, Tretinoin, Risk Factors, Reproductive System, Genetic Similarity, Antineoplastic Agents, Overall Survival, Acute Promyelocytic Leukemia, and Retinoic Acid Receptor
Somatic mutations of the spliceosomal machinery occur frequently in adult patients with myelodysplastic syndrome (MDS). We resequenced SF3B1, U2AF35, and SRSF2 in 371 children with MDS or juvenile myelomonocytic leukemia. We found... more
Somatic mutations of the spliceosomal machinery occur frequently in adult patients with myelodysplastic syndrome (MDS). We resequenced SF3B1, U2AF35, and SRSF2 in 371 children with MDS or juvenile myelomonocytic leukemia. We found missense mutations in 2 juvenile myelomonocytic leukemia cases and in 1 child with systemic mastocytosis with MDS. In 1 juvenile myelomonocytic leukemia patient, the SRSF2 mutation that initially coexisted with an oncogenic NRAS mutation was absent at relapse, whereas the NRAS mutation persisted and a second, concomitant NRAS mutation later emerged. The patient with systemic mastocytosis and MDS carried both mutated U2AF35 and KIT in a single clone as confirmed by clonal sequencing. In the adult MDS patients sequenced for control purposes, we detected previously reported mutations in 7/30 and a novel SRSF2 deletion (c.284_307del) in 3 of 30 patients. These findings implicate that spliceosome mutations are rare in pediatric MDS and juvenile myelomonocytic leukemia and are unlikely to operate as driver mutations.
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Adoptive immune cell therapy represents one of the most promising fields of investigation in allogeneic haematopoietic stem cell transplantation (allo-HSCT). Preliminary studies indicate that adoptive immune cell therapy can be used to... more
Adoptive immune cell therapy represents one of the most promising fields of investigation in allogeneic haematopoietic stem cell transplantation (allo-HSCT). Preliminary studies indicate that adoptive immune cell therapy can be used to restore the immunocompetence of allo-HSCT recipients towards widespread pathogens in the early post-transplant period. These strategies can be of fundamental importance in patients given a T-cell-depleted allograft, a type of transplant that has been performed increasingly over the last few years. A few seminal studies have recently documented that prevention/treatment of Epstein-Barr-virus-related lymphoproliferative disorders, human cytomegalovirus disease and invasive aspergillosis can be obtained through infusion of pathogen-specific T-cell lines or clones. Several efforts are also being directed towards the identification of strategies capable of selecting and/or strengthening specific graft-vs-leukaemia responses. In this regard, strategies of ex-vivo generation and expansion of clones or cell lines, specifically or preferentially leukaemia reactive, have been developed.
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Every week, approximately 400 liters of water used for dialysate production come into direct contact, through the semi-permeable membrane of the dialyzer, with the dialysis patient's blood stream. Therefore, submitting municipal water... more
Every week, approximately 400 liters of water used for dialysate production come into direct contact, through the semi-permeable membrane of the dialyzer, with the dialysis patient's blood stream. Therefore, submitting municipal water to an adequate depuration process before its use for dialysis becomes necessary. Problems related to the implementation, updating and management of a dialysis water treatment system are analyzed. The results of the most recent multicenter studies on dialysis fluids quality are also reviewed. The best approach to plan, implement and manage a dialysis water treatment system, first, consists of defining the standards of chemical and microbiological water quality. The most diffused and commonly accepted standards are those recommended by the Association for Advancement of Medical Instrumentation (AAMI) and the European Pharmacopea (EP), which allow a maximum bacterial growth of, respectively, 200 CFU/ml and 100 CFU/mL and a maximum endotoxin concentrat...
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The different permeability of high-flux and low-flux dialysis membranes results in different removal capacity, particularly for uremic toxins of middle and large molecular weight. High-flux dialysers have been evaluated in clinical and... more
The different permeability of high-flux and low-flux dialysis membranes results in different removal capacity, particularly for uremic toxins of middle and large molecular weight. High-flux dialysers have been evaluated in clinical and epidemiological studies for their effect on mortality, morbidity, dialysis-related amyloidosis, nutritional status, response to erythropoietin treatment, dialysis tolerance and the preservation of residual renal function. Many of these studies, however, lack a prospective design and randomised treatment allocation, or have too few patients and too short a follow-up. Therefore, this clinical trial was designed to prospectively investigate the long-term effect of membrane permeability on clinical outcome in a larger number of patients. The primary objective is to compare the effect of membrane permeability on mortality of patients on bicarbonate hemodialysis and treated with a minimum dialysis dose. Patients included in the study should have been on hem...
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A protective effect of angiotensin-converting enzyme (ACE) inhibitors has been shown in patients with diabetic nephropathy but has not been clearly established in nondiabetic renal disease. A multicenter European study was designed to... more
A protective effect of angiotensin-converting enzyme (ACE) inhibitors has been shown in patients with diabetic nephropathy but has not been clearly established in nondiabetic renal disease. A multicenter European study was designed to determine whether the ACE inhibitor benazepril was safe and effective in protecting residual renal function in patients with various renal diseases and mild to moderate renal failure. The trial involved 583 patients from 49 centers in Italy, France, and Germany. The patients were randomized to receive benazepril or placebo plus other antihypertensive agents, the target being a diastolic blood pressure of less than 90 mm Hg. Thirty-one patients in the benazepril group and 57 patients in the placebo group reached the end point [the time elapsed from entry to (a) doubling of serum creatinine (SCr) concentrations and (b) start of renal replacement therapy; p < 0.001 at 3 years]. The associated reduction in the relative risk of reaching the end point was...