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Sirolimus Conversions in African-American Renal Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01005706
First Posted: November 2, 2009
Last Update Posted: March 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Medical University of South Carolina
  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
Absence; Kidney Drug: rapamune, mycophenolate mofetil and steroid Drug: tacrolimus, sirolimus and steroid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]
    Number of Participants with Kidney Rejections


Enrollment: 40
Study Start Date: August 2009
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01005706     History of Changes
Other Study ID Numbers: Wyeth Study - HR 19042
HR19042
First Submitted: October 9, 2009
First Posted: November 2, 2009
Results First Submitted: May 14, 2015
Results First Posted: March 11, 2016
Last Update Posted: March 11, 2016
Last Verified: February 2014

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