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

September 21, 2023 updated by: University of Miami

Tacrolimus and Mycophenolate Versus Tacrolimus and Sirolimus vs. Neoral and Sirolimus Used in Combination in Cadaver and Non-HLA Identical Living Related Kidney Transplants

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Division of Transplantation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Tacrolimus/Sirolimus
Drug: Tacrolimus/Sirolimus
Experimental: B
Tacrolimus/MMF
Drug: Tacrolimus/MMF
Experimental: C
Neoral/Sirolimus
Drug: Neoral/Sirolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of acute rejection episodes
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome 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
Time Frame: 1, 3, and 5 years
1, 3, and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Wyeth-Ayesrst Pharmaceuticals, Roche Laboratories, and Fujusawa Healthcare, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (Actual)

December 1, 2001

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 19, 2008

First Posted (Estimated)

May 21, 2008

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#19990664

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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