Sirolimus Conversions in African-American Renal Transplant Recipients

NCT01005706

Last updated date
Study Location
The Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Absence; Kidney
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Absence; KidneySirolimus Conversions in African-American Renal Transplant Recipients
NCT01005706
  1. Charleston, South Carolina
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Sirolimus Conversions in African-American Renal Transplant Recipients
Official Title  ICMJE A Pilot Study Comparing Two Different Sirolimus-based Transition Regimens in African-American Renal Transplant Recipients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Absence; Kidney
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • 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.

    Intervention: Drug: rapamune, mycophenolate mofetil and steroid
  • 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.

    Intervention: Drug: tacrolimus, sirolimus and steroid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01005706
Other Study ID Numbers  ICMJE Wyeth Study - HR 19042
HR19042
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Charles Bratton, MDMedical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP