Chronic Renal Failure Clinical Trial
Official title:
Prospective, Randomized, Controlled, Multicenter Study of the Solaris DE Endoprosthesis in the Treatment of Venous Outflow Stenosis or Occlusion in Hemodialysis Patients
The goal of this clinical trial is to demonstrate the safety and efficacy of Solaris DE Endoprosthesis in the treatment of stenosis or occlusion within the outflow circuit of the dialysis access including arteriovenous (AV) fistula and synthetic AV graft. Participants will be treated with Solaris DE Endoprosthesis. Researchers will compare the treatment with investigational product to Percutaneous Transluminal Angioplasty (PTA) alone within the AV fistula cohort in order to demonstrate superiority of Solaris DE.
This is a prospective, randomized (1:1), controlled, multicenter study to investigate the safety and efficacy of the Solaris DE Endoprosthesis in the treatment of hemodialysis patients with stenosis or occlusion of the venous outflow circuit. The study population includes two cohorts: - AVF cohort: participants presenting an arteriovenous fistula (AVF) stenosis or occlusion of the peripheral venous outflow circuit, including the cephalic arch, will be randomized 1:1 between treatment with the test device (Solaris DE) or standard treatment by Percutaneous Transluminal Angioplasty (PTA) alone); - AVG cohort: participants with an arteriovenous graft (AVG) presenting stenosis or occlusion at the graft vein anastomosis or juxta-anastomosis or at the segment of the prosthesis exit circuit, will be treated with the test device (Solaris DE) only. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02565459 -
MSC and Kidney Transplant Tolerance (Phase A)
|
Phase 1 | |
| Recruiting |
NCT01876017 -
Safety and Efficacy of BMMNC in Patients With Chronic Renal Failure
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02356419 -
rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics
|
Phase 1 | |
| Withdrawn |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 |
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 |
NCT00597753 -
Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
|
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 |