Comparison of Tacrolimus and Myfortic Versus Tacrolimus and Sirolimus

NCT ID: NCT01038505

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-01-31

Brief Summary

The investigators center has also analyzed data over the last 7 years from deceased donor (DD) and living donor (LD) kidney transplant recipients who were randomized into 3 immunosuppressive arms between 2000 and 2001. Thus the goal of the investigators study is to reduce the toxic effects of traditional immunosuppressive regimens involving high-dose calcineurin inhibitor agents by comparing low-dose TAC-MYF with low-dose TAC and de novo SRL regimens. In order to minimize exposure to TAC, the investigators center has previously shown favorable outcomes using combination Thymoglobulin and Zenapax (Daclizumab) for anti-lymphocyte induction in the investigator population of patients.

Detailed Description

A total of 150 randomized patients divided into 2 arms: 75 patients will be randomized to receive TAC-SRL, and 75 patients to receive TAC-MYF.

Conditions

Living Donor Kidney Transplants Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tacrolimus and Myfortic

Immunosuppressive

Group Type: ACTIVE_COMPARATOR

Tacrolimus, Myfortic and Sirolimus

Intervention Type: DRUG

Immunosuppressive drugs

Tacrolimus and Sirolimus

Immunosuppressive

Group Type: ACTIVE_COMPARATOR

Tacrolimus, Myfortic and Sirolimus

Intervention Type: DRUG

Immunosuppressive drugs

Interventions

Tacrolimus, Myfortic and Sirolimus

Immunosuppressive drugs

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Non-HLA identical living donor kidney transplant patients

Exclusion Criteria

• Patient has previously received or is receiving an organ transplant other than a kidney.
• Patient is receiving an ABO incompatible donor kidney.
• Recipient or donor is known seropositive for human immunodeficiency (HIV) or Hepatitis C virus, or Hepatitis B virus antigenemia.
• Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully, or carcinoma in-situ of the cervix that has been treated successfully.
• Patients with significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range at our center.
• Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with study objectives.
• Patient is currently participating in another clinical trial of an investigational drug in the 30 days prior to transplant.
• Patient will be receiving any immunosuppressive agent other than those prescribed in the study.
• Patient is unable to take medications orally or via nasogastric tube by the morning of the second day following completion of the transplant procedure (i.e., skin closure).
• Patient is receiving or may require Warfarin, Fluvastatin, or herbal supplements during the study.
• Concurrent use of Astemizole, Pimozide, Cisapride, Terfenadine, or Ketoconazole.
• Patient has a known hypersensitivity to Tacrolimus, Thymoglobulin®, IL-2 receptor inhibitor monoclonal antibodies, Rapamune, Myfortic®, or corticosteroids.
• Patient is pregnant or lactating.
• 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 >200 mg/dl.
• Patient is unlikely to comply with the visits scheduled in the protocol.
• Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
• If Tacrolimus cannot be instituted for longer than 5 days postoperatively.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Other Identifiers

20090531

Identifier Type: -

Identifier Source: org_study_id