The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients

Completed · Phase 4

Conditions studied: Kidney Diseases

In brief

This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.

Key facts

Study ID

NCT00275535

Run by

Mayo Clinic

People needed

165

Starts

2001-04-01

Expected to finish

2008-12-01

Last updated by the study team

2011-12-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Living and deceased donor kidney transplant recipients at the Mayo Clinic, Rochester, Minnesota

You may not qualify if…

• Patients with type 1 diabetes less than 50 years of age who receive a living donor kidney transplant followed by a pancreas transplant
• Pediatric patients (<18 years of age)
• Multi-organ transplants (e.g., kidney-pancreas, kidney-liver)
• ABO-incompatible or positive crossmatch recipients (ABO incompatibility is an immune system reaction that occurs when blood from two different and incompatible blood types are mixed together.)
• Patients with severe hyperlipidemia (serum cholesterol >350 mg/dl or serum triglycerides >500 mg/dl
• Patients with severe leukopenia (White Blood Cell count [WBC]<3000 10\^3/ml)
• Patients unwilling to return to the transplant center for late follow-up visits
• Body mass index (BMI) ≥ 32 with incisional problems post transplant (as determined by renal transplant surgeon

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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