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

University of Wisconsin (UW)

Status: Completed

Conditions: Renal Transplantation

Treatments: Drug: Corticosteroid withdrawal

Study type: Interventional

Funder types: Other

Identifiers

NCT00214279

CEL340

2002-040

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

1

No Intervention group

Description:

Remain on 3-drug standard of care immunosuppression including prednisone

2

Experimental group

Description:

Corticosteroid withdrawal / prednisone taper over 14 weeks

Treatment:

Drug: Corticosteroid withdrawal