Completed

NCT Number: NCT01005706

Sirolimus Conversions in African-American Renal Transplant Recipients

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.

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Key information

Conditions

Absence; Kidney

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

rapamune, mycophenolate mofetil and steroid

Drug

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.

Other names: rapamune (Sirolimus), mycophenolate mofetil (Cellcept)

tacrolimus, sirolimus and steroid

Drug

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.

Other names: tacrolimus (Prograf), rapamune (Sirolimus)

Primary outcomes

Effectiveness and Safety of a Particular Drug Regimen to Prevent Kidney Rejection

Time frame: 12 months

Number of Participants with Kidney Rejections

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

A Pilot Study Comparing Two Different Sirolimus-based Transition Regimens in African-American Renal Transplant Recipients

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2014
First posted: Nov 2, 2009
Registry last updated: Mar 11, 2016

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.