Sirolimus Conversions in African-American Renal Transplant Recipients
Completed · Not applicable
Conditions studied: Absence; Kidney
In brief
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.
Key facts
- Study ID
- NCT01005706
- Run by
- Medical University of South Carolina
- People needed
- 40
- Starts
- 2009-08-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2016-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- The Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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