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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2002-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients

NCT00266123

Graft Rejection Kidney Failure Kidney Transplant

COMPLETED PHASE4

Comparison of Tacrolimus and Myfortic Versus Tacrolimus and Sirolimus

NCT01038505

Living Donor Kidney Transplants Patients

WITHDRAWN PHASE4

Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients

NCT00064701

Kidney Transplantation

COMPLETED PHASE3

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

NCT00275535

Kidney Diseases

COMPLETED PHASE4

The Comparison of Three Different Immunosuppressant Regimens in Kidney Transplant Recipients.

NCT00275522

Kidney Transplant

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adult Primary Kidney Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Tacrolimus/Sirolimus

Group Type EXPERIMENTAL

Tacrolimus/Sirolimus

Intervention Type DRUG

B

Tacrolimus/MMF

Group Type EXPERIMENTAL

Tacrolimus/MMF

Intervention Type DRUG

C

Neoral/Sirolimus

Group Type EXPERIMENTAL

Neoral/Sirolimus

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tacrolimus/Sirolimus

Intervention Type DRUG

Tacrolimus/MMF

Intervention Type DRUG

Neoral/Sirolimus

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No