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

University of Miami

Status and phase: Completed; Phase 4

Conditions: Adult Primary Kidney Transplantation

Treatments: Drug: Tacrolimus/Sirolimus; Drug: Tacrolimus/MMF; Drug: Neoral/Sirolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT00681213

IRB#19990664

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

A

Experimental group

Description:

Tacrolimus/Sirolimus

Treatment:

Drug: Tacrolimus/Sirolimus

B

Experimental group

Description:

Tacrolimus/MMF

Treatment:

Drug: Tacrolimus/MMF

C

Experimental group

Description:

Neoral/Sirolimus

Treatment:

Drug: Neoral/Sirolimus