Sirolimus Conversions in African-American Renal Transplant Recipients

Not Applicable

Completed

• Conditions: Absence; Kidney
• Interventions: Drug: tacrolimus, sirolimus and steroid; Drug: rapamune, mycophenolate mofetil and steroid

• Registration Number: NCT01005706
• Lead Sponsor: Medical University of South Carolina

Brief Summary

This study's focus is to compare the level effectiveness and safety of regimens involving Sirolimus, Cellcept and steroid to Prograf, Sirolimus and steroid in African-American recipients of kidney transplants.

Detailed Description

A major concern in transplantation is finding a successful regimen of medications to lower the potential for the body to reject the newly transplanted organ. The regimens in kidney transplantation include tacrolimus, sirolimus, mycophenolate mofetil and steroids. This study will compare the effectiveness and safety of a regimen including Sirolimus, Prograf, and steroids compared to a regimen including Sirolimus, Cellcept and steroids. These regimens have already been researched in the Caucasian population, and both drug regimens are FDA approved. This study's focus is on the effectiveness and safety of these regimens in African-Americans.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-10-09
• Study First Submitted QC: 2009-10-30
• Study First Posted: 2009-11-01
• Primary Completion: 2013-07
• Status Verified: 2014-02
• Study Completion: 2014-07
• Results First Submitted: 2015-05-14
• Results First Submitted QC: 2016-02-12
• Last Update Submitted: 2016-02-12
• Results First Posted: 2016-03-11
• Last Update Posted: 2016-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• At least 18 years of age and able to give informed consent
• African-American ethnicity
• Received a first or second non-ECD cadaveric or living donor renal transplant
• Transplant occurred during the past 6 to 24 weeks
• Patient has stable graft function, defined as no change of greater than 30% of baseline serum creatinine during the past month and no acute rejection in the past 6 weeks
• Estimated GFR using the modified MDRD equation of at least 40 mL/min10 at time of enrollment into the study
• Currently receiving tacrolimus, mycophenolate mofetil (at least 1 gm per day), and corticosteroids as their immunosuppression regimen.

Exclusion Criteria

• Biopsy proven acute rejection episode that occurred within the past 6 weeks
• Malignancy within the past 3 years, except for non-melanoma skin cancer
• Any known intolerances to current immunosuppressant regimen necessitating withdrawal of the offending agent
• Currently enrolled in an investigational trial
• Woman of child bearing potential not utilizing an effective form of birth control
• Patients with uncontrolled dyslipidemia, defined at serum fasting LDL >200 mg/dL or serum fasting triglycerides >500 mg/dL.
• Patients with a spot urine protein to creatinine ratio of > 800 mg of protein per gram of creatinine.
• WBC < 3,000 cells/mm3
• Platelets < 100,000 cells/mm3

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tacrolimus Minimization Arm	tacrolimus, sirolimus and steroid	Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml. At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.
Tacrolimus Withdrawal Arm	rapamune, mycophenolate mofetil and steroid	At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml. Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator.

Primary Outcome Measures

Name	Time	Method
Effectiveness and Safety of a Particular Drug Regimen to Prevent Kidney Rejection	12 months	Number of Participants with Kidney Rejections

Trial Locations

Locations (1)

The Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States