Sirolimus Conversions in African-American Renal Transplant Recipients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01005706
First received: October 9, 2009
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Kidney Transplantation
Drug: rapamune, mycophenolate mofetil and steroid
Drug: tacrolimus, sirolimus and steroid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study Comparing Two Different Sirolimus-based Transition Regimens in African-American Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Effectiveness and safety of a particular drug regimen to prevent kidney rejection [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: August 2009
Estimated Study Completion Date: July 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tacrolimus Withdrawal Arm

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.

Drug: 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.

Other Names:
  • rapamune (Sirolimus)
  • mycophenolate mofetil (Cellcept)
Active Comparator: Tacrolimus Minimization Arm

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.

Drug: 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.

Other Names:
  • tacrolimus (Prograf)
  • rapamune (Sirolimus)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005706

Locations
United States, South Carolina
The Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Charles Bratton, MD Medical University of South Carolina
  More Information

Publications:

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01005706     History of Changes
Other Study ID Numbers: Wyeth Study - HR 19042, HR19042
Study First Received: October 9, 2009
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tacrolimus
Sirolimus
Everolimus
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014