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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214279
First received: September 14, 2005
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Renal Transplantation
Drug: Corticosteroid withdrawal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MMF Monotherapy and Immune Regulation in Kidney Transplant Recipients: Part 1 Steroid Withdrawal

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Incidence of Allograft rejection [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Renal function as determined by serum creatinine [ Time Frame: measure after 36 months ] [ Designated as safety issue: Yes ]
  • Allograft Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Immunological function as determined by Trans-vivo delayed hypersensitivity assay (TV-DTH) [ Time Frame: Day 0 (pre-transplant) ] [ Designated as safety issue: No ]
    Research assay done to determine correlation between the status of donor specific regulation (DSR) and rates of rejection in both arms of the study.


Enrollment: 32
Study Start Date: May 2002
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00214279

Locations
United States, Wisconsin
Unversity of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Hans Sollinger, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214279     History of Changes
Other Study ID Numbers: 2002-040, CEL340
Study First Received: September 14, 2005
Last Updated: June 22, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 01, 2014