Expired Study
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Miami, Florida 33136


Comparison of outcomes/safety/and tolerability of SRL/FK/Pred vs. FK/MMF/Pred vs. SRL/Neoral®/Pred in cadaveric and non-HLA identical LRD kidney transplants.


Inclusion Criteria: - Age >14 years - Weight > 40 kg - Primary renal allograft: cadaveric or mismatched living donor - Negative standard cross match for T-cells - Women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception throughout the study period and for 3 months after discontinuation of study medication (3yrs, 3 mos.) - Signed and dated informed consent (Parent or legal guardian must provide written consent for patients <18 years of age) Exclusion Criteria: - Evidence of systemic infection - History of malignancy within 10 years (with the exception of localized skin cancer) - Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase - Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole - Known hypersensitivity to sirolimus and its derivatives - Patients with a screening/baseline (or within 96 hours of transplant) - total white blood cell count < 4000/mm3; - platelet count < 100,000/mm3; - fasting triglycerides > 400 mg/dl (> 4.6 mmol/L); - fasting total cholesterol > 300 mg/dl (> 7.8 mmol/L); - fasting HDL-cholesterol < 30 mg/dl; - fasting LDL-cholesterol > 200mg/dl



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Miami, Florida 33136
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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