Study Evaluating Rapamune® Maintenance Regimen

Status Completed

Clinical Trial Summary

Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.

Secondary :

1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients.

2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Renal Transplant

Clinical Trial Details

NCT number	NCT00478608
Study type	Interventional
Source	Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status	Completed
Phase	Phase 3
Start date	March 2007
Completion date	November 2008

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01220050` - Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism	Phase 2
Completed	`NCT00820469` - Study of the Influence of Plasma Exchange on the Pharmacokinetics of Rituximab	Phase 4
Completed	`NCT00239005` - Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation	Phase 4
Completed	`NCT00270153` - The Use of ACE Inhibitors in the Early Renal Post-transplant Period	Phase 1
Completed	`NCT02711826` - Treg Therapy in Subclinical Inflammation in Kidney Transplantation	Phase 1/Phase 2
Completed	`NCT03837522` - Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies	N/A
Not yet recruiting	`NCT06025240` - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Completed	`NCT01256294` - Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients	Phase 4
Suspended	`NCT01059292` - TIPE2 Associated With Kidney Transplant	N/A
Completed	`NCT00547040` - Arterial Stiffness and Calcifications in Incident Renal Transplant Recipients
Suspended	`NCT03043339` - Characterization Of the Intestinal Microbiome Evolution After Kidney Transplant Donation or Receipt
Completed	`NCT02581644` - Assessment of Effectiveness of Belatacept Patient Alert Card in Patients Following Renal Transplantation in a Sample of EU Countries	N/A
Completed	`NCT01728012` - Long-term Cardiovascular Risk Following Successful Renal Transplantation	N/A
Terminated	`NCT01011114` - Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant	N/A
Completed	`NCT02117596` - Calcineurin Inhibitor Based Immunosuppression Withdrawal	N/A
Completed	`NCT00555373` - Pediatric Kidney Transplant Study of Sirolimus, Mycophenolate Mofetil, and Corticosteroids vs Calcineurin Inhibitor Based Immunosuppression	N/A
Recruiting	`NCT05156086` - Safety and Effectiveness of COVID-19 Vaccine in Kidney Transplant Recipients
Completed	`NCT01334333` - Comparison of Medication Adherence Between Once and Twice Daily Tacrolimus in Stable Renal Transplant Recipients	Phase 4
Recruiting	`NCT03107858` - The Effect of Norepinephrine Versus Dopamine in Renal Transplant Recipients on Postoperative Graft Function	Phase 2/Phase 3
Completed	`NCT00352547` - Influence of Genes on Sirolimus Metabolism in Patients With Kidney Transplantation	N/A