N/A
Completed N=40
Sirolimus Conversions in African-American Renal Transplant Recipients
Absence; Kidney
Source: ClinicalTrials.gov NCT01005706 ↗
Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Mar 2016
Primary outcomePrimary: Effectiveness and Safety of a Particular Drug Regimen to Prevent Kidney Rejection — 4; 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness and Safety of a Particular Drug Regimen to Prevent Kidney Rejection |
4; 1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01005706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.