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

NCT ID: NCT00214279

Last Updated: 2012-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2007-11-30

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.

Conditions

Renal Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Remain on 3-drug standard of care immunosuppression including prednisone

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

Corticosteroid withdrawal / prednisone taper over 14 weeks

Group Type: EXPERIMENTAL

Corticosteroid withdrawal

Intervention Type: DRUG

prednisone withdrawal, with maintenance mycophenolate mofetil therapy and either cyclosporine or tacrolimus

Interventions

Corticosteroid withdrawal

prednisone withdrawal, with maintenance mycophenolate mofetil therapy and either cyclosporine or tacrolimus

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans Sollinger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Unversity of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

CEL340

Identifier Type: -

Identifier Source: secondary_id

2002-040

Identifier Type: -

Identifier Source: org_study_id