Chronic Renal Failure Clinical Trial
Official title:
Multicentric Randomized Trial of the Impact of Hemodialysis With Polymethylmetacrylate Membrane on the Improvement of Humoral Immune Response in the Hemodialyzed Patients: Application to Hepatitis B Vaccination and Correlation to sCD40 Clearing
The aim of this study is to improve the humoral immune response efficiency of hemodialyzed patient by the use of PMMA membrane (BK-F) able to clear the soluble form of CD40 in a model of anti-HBV vaccination
Chronic renal failure is associated with humoral immune alterations characterized by a
diminished vaccine response notably against hepatitis B virus (HBV). Defects in cellular
contact between immunological cells have been hypothesized to explain this observation but
the precise mechanism leading to this "immunocompromised" status is not clear. The soluble
form of CD40 (sCD40) is dramatically increased in the serum of uremic patients, particularly
in the hemodialyzed patients. This molecule acts like an inhibitor of the CD40/CD154
contact, which is pivotal in the establishment of a proper humoral immune response. It has
been shown that the most elevated sCD40 levels are associated with a lack of response to HBV
vaccination in the hemodialyzed patients. The majority of the hemodialysis membranes,
including high flux polysulfone membranes are unable to clear sCD40 from the sera. However,
we found that the high flux polymethylmetacrylate (PMMA) membrane (BK-F Toray Medical
Company, Japan) allows for sCD40 clearing.
The aim of this study is to assess the effect of dialysis on PMMA membrane on the
improvement of humoral immune response through the efficiency of HBV vaccination in
hemodialysed patients who were non responders to one ore more previous vaccination and its
link to sCD40 clearing.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02565459 -
MSC and Kidney Transplant Tolerance (Phase A)
|
Phase 1 | |
| Recruiting |
NCT02356419 -
rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics
|
Phase 1 | |
| Recruiting |
NCT01876017 -
Safety and Efficacy of BMMNC in Patients With Chronic Renal Failure
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03019159 -
Assessment of a Follow-up With Tele-consulting for Patients With Renal Failure Under Peritoneal Dialysis
|
N/A | |
| Completed |
NCT02047006 -
Dose-finding of Rivaroxaban in Hemodialysis
|
Phase 4 | |
| Completed |
NCT01617824 -
Rapid Effects Linagliptin on Monocyte Polarization and Endothelial Progenitor Cells in Type 2 Diabetes
|
Phase 4 | |
| Completed |
NCT00597753 -
Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
|
Phase 3 | |
| Completed |
NCT00828776 -
Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal Failure
|
Phase 2/Phase 3 | |
| Completed |
NCT00379899 -
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
|
Phase 4 | |
| Terminated |
NCT00372489 -
Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD
|
Phase 2 | |
| Completed |
NCT00228436 -
Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients
|
Phase 2 | |
| Completed |
NCT03772171 -
Estimate for Dietary Intakes and Hemodialysis Patients
|
||
| Recruiting |
NCT02586402 -
Safety & Efficacy of Pegolsihematide for Treatment of Anemia in Participants on Dialysis
|
Phase 2 | |
| Completed |
NCT01879618 -
Use Of Fragmin In Hemodialysis
|
Phase 3 | |
| Not yet recruiting |
NCT01346215 -
Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure
|
Phase 3 | |
| Completed |
NCT01220843 -
FGF23 Reduction : Efficacy of a New Phosphate Binder in CHronic Kidney Disease
|
Phase 3 | |
| Completed |
NCT01111630 -
Study of Erythropoietin (EPO) Administration Schedule
|
Phase 4 | |
| Completed |
NCT00742716 -
Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
|
Phase 2 | |
| Completed |
NCT00597584 -
Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
|
Phase 3 | |
| Completed |
NCT00598273 -
Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
|
Phase 3 |