Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for

Status Completed

Clinical Trial Summary

Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. Current therapeutic approaches include cyclosporine reduction or discontinuation. It is unclear whether discontinuation of low dose cyclosporine also has a beneficial effect, i.e. is there a threshold effect for cyclosporine nephrotoxicity?

Study Design: Heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a) no change; or b) discontinuation of cyclosporine and initiation of rapamycin immunosuppression.

Read-Out: Renal function after 6 months; tolerability; and safety were assessed.

Clinical Trial Description

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00123331
Study type	Interventional
Source	Heidelberg University
Contact
Status	Completed
Phase	Phase 4
Start date	October 2003
Completion date	April 2005

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02763410` - Impact of the Composition of Packed Red Blood Cell Supernatant on Renal Dysfunction and Posttransfusion Immunomodulation
Active, not recruiting	`NCT03183245` - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis	Phase 3
Completed	`NCT04084301` - Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury	N/A
Completed	`NCT03292029` - Pilot Medical Evaluation of the T50 Test	N/A
Suspended	`NCT04589065` - SCD for CRS in Congestive Heart Failure (CHF) (No Left Ventricular Assist Device)	N/A
Completed	`NCT03806998` - Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure	Phase 3
Active, not recruiting	`NCT03672110` - Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen	Phase 3
Completed	`NCT02325726` - RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery.	N/A
Completed	`NCT02116270` - Accelerated Immunosenescence and Chronic Kidney Disease	N/A
Completed	`NCT01388270` - Effect of a Pre Heparin Coated Dialysis Filter on Coagulation During Hemodialysis	Phase 4
Completed	`NCT01859273` - Adherence Enhancement for Renal Transplant Patients	N/A
Completed	`NCT00966615` - The Effect of Neutral Peritoneal Dialysis (PD) Solution With Minimal Glucose-Degradation-Product (GDP) on Fluid Status and Body Composition	Phase 4
Completed	`NCT01476995` - Prognostic Indicators as Provided by the EPIC ClearView	N/A
Completed	`NCT01187953` - Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx	Phase 3
Completed	`NCT01008631` - The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers	N/A
Completed	`NCT00765661` - Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients	Phase 2
Completed	`NCT00737672` - GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis	Phase 3
Completed	`NCT00808691` - Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit	N/A
Recruiting	`NCT00470769` - The Efficacy of Color-Doppler Ultrasonography to Assess the Renal Blood Flow With the Estimation of GFR	N/A
Terminated	`NCT00338455` - Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC	Phase 2

Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms