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

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

Secondary Outcome Measures:
  • Renal function as determined by serum creatinine [ Time Frame: measure after 36 months ]
  • Allograft Survival [ Time Frame: 3 years ]
  • Immunological function as determined by Trans-vivo delayed hypersensitivity assay (TV-DTH) [ Time Frame: 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.

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


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00214279

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

Responsible Party: University of Wisconsin, Madison Identifier: NCT00214279     History of Changes
Other Study ID Numbers: 2002-040
Study First Received: September 14, 2005
Last Updated: June 22, 2012

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on March 27, 2017