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

Renal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214279
• Other study ID #: 2002-040
• Secondary ID: CEL340
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: June 22, 2012
• Start date: May 2002
• Est. completion date: November 2007

Study information

• Verified date: June 2012
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• Corticosteroid withdrawal
prednisone withdrawal, with maintenance mycophenolate mofetil therapy and either cyclosporine or tacrolimus

Locations

Country	Name	City	State
United States	Unversity of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Allograft rejection		3 years	No
Secondary	Renal function as determined by serum creatinine		measure after 36 months	Yes
Secondary	Allograft Survival		3 years	No
Secondary	Immunological function as determined by Trans-vivo delayed hypersensitivity assay (TV-DTH)	Research assay done to determine correlation between the status of donor specific regulation (DSR) and rates of rejection in both arms of the study.	Day 0 (pre-transplant)	No