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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00214279
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 26, 2012
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Renal Transplantation Drug: Corticosteroid withdrawal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MMF Monotherapy and Immune Regulation in Kidney Transplant Recipients: Part 1 Steroid Withdrawal
Study Start Date : May 2002
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Incidence of Allograft rejection [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Renal function as determined by serum creatinine [ Time Frame: measure after 36 months ]
  2. Allograft Survival [ Time Frame: 3 years ]
  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00214279

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United States, Wisconsin
Unversity of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
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Principal Investigator: Hans Sollinger, MD University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison Identifier: NCT00214279    
Other Study ID Numbers: 2002-040
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012