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Tacrolimus/Sirolimus Versus Tacrolimus/Mycophenolate Mofetil (MMF) Versus Neoral/Sirolimus in Adult, Primary Kidney Transplantation

NCT00681213

CompletedPhase 4

Sponsor: University of Miami

Conditions: Adult Primary Kidney Transplantation

Interventions: Tacrolimus/Sirolimus, Tacrolimus/MMF, Neoral/Sirolimus

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Miami, Florida, United States