Trial | NCT00681213  Report issue

Title

Tacrolimus/Sirolimus Versus Tacrolimus/Mycophenolate Mofetil (MMF) Versus Neoral/Sirolimus in Adult, Primary Kidney Transplantation
Tacrolimus and Mycophenolate Versus Tacrolimus and Sirolimus vs. Neoral and Sirolimus Used in Combination in Cadaver and Non-HLA Identical Living Related Kidney Transplants

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
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.
Study Started
May 31
2000
Primary Completion
Dec 31
2001
Study Completion
Dec 31
2002
Last Update
Sep 22
2023

Drug Tacrolimus/Sirolimus

Drug Tacrolimus/MMF

Drug Neoral/Sirolimus

A Experimental

Tacrolimus/Sirolimus

B Experimental

Tacrolimus/MMF

C Experimental

Neoral/Sirolimus

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
No Results Posted