MMF Monotherapy and Immune Regulation in Kidney Transplant Recipients: Part 1 Steroid Withdrawal

Not Applicable

Completed

• Conditions: Renal Transplantation
• Interventions: Drug: Corticosteroid withdrawal

• Registration Number: NCT00214279
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

Part 1 of the study is to gradually withdraw steroids in a group of 50 older renal transplant recipients, converting then from the 3 drug regimen to a 2 drug regimen (cyclosporine and MMF), while carefully monitoring their graft function. 25 subjects would serve as control patients in the study and would remain on the 3 drug regimen (steroids, cyclosporine and MMF). Immunologic status will be determined before and after IS withdrawal using a delayed-type hypersensitivity (DTH) transfer test previously described in the original submission. Both the steroid withdrawal subjects and the control subjects will undergo the DTH testing throughout the 3 years of study participation.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-21
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-22
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patient who have received a kidney transplant during the "MMF era"
• Patients who have stable graft function indicated by a serum creatinine of < 1.8 mg/dl, or a calculated creatinine clearance of > 50 ml/minute

Exclusion Criteria

• Patients who have had > 1 rejection episode,
• Patients who have had a rejection episode within the past year;
• Patients who are steroid dependent due to pre-existing disease (for example, RA or SLE

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Corticosteroid withdrawal	Corticosteroid withdrawal / prednisone taper over 14 weeks

Primary Outcome Measures

Name	Time	Method
Incidence of Allograft rejection	3 years

Secondary Outcome Measures

Name	Time	Method
Renal function as determined by serum creatinine	measure after 36 months
Allograft Survival	3 years
Immunological function as determined by Trans-vivo delayed hypersensitivity assay (TV-DTH)	Day 0 (pre-transplant)	Research assay done to determine correlation between the status of donor specific regulation (DSR) and rates of rejection in both arms of the study.

Trial Locations

Locations (1)

Unversity of Wisconsin; 🇺🇸 Madison, Wisconsin, United States