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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00681213

Enrollment

150

Registered

2008-05-21

Start date

2000-05-31

Completion date

2002-12-31

Last updated

2023-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Primary Kidney Transplantation

Brief summary

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.

Interventions

DRUGTacrolimus/Sirolimus

DRUGTacrolimus/MMF

DRUGNeoral/Sirolimus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence and severity of acute rejection episodes	1 year

Secondary

Measure	Time frame
1. Graft loss 2. Renal function as determined by serum creatinine and calculated creatinine clearance (using the Cockcroft-Gault method) six and 12 months	1, 3, and 5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026