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Completed

NCT Number: NCT00214279

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

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.

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Key information

Conditions

Renal Transplantation

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unversity of Wisconsin

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corticosteroid withdrawal

Drug

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

Primary outcomes

  1. Incidence of Allograft rejection

    Time frame: 3 years

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Jun 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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