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

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.

Study Overview

• Status: Completed
• Conditions: Renal Transplantation
• Intervention / Treatment: Drug: Corticosteroid withdrawal

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Unversity of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1; Remain on 3-drug standard of care immunosuppression including prednisone
Experimental: 2; Corticosteroid withdrawal / prednisone taper over 14 weeks	Drug: Corticosteroid withdrawal; prednisone withdrawal, with maintenance mycophenolate mofetil therapy and either cyclosporine or tacrolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Allograft rejection	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Research assay done to determine correlation between the status of donor specific regulation (DSR) and rates of rejection in both arms of the study.	Day 0 (pre-transplant)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Hans Sollinger, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: September 14, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): June 26, 2012
• Last Update Submitted That Met QC Criteria: June 22, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 2002-040; CEL340

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No