Comparison of Tacrolimus and Myfortic Versus Tacrolimus and Sirolimus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01038505
Recruitment Status : Withdrawn (Lost funding source)
First Posted : December 24, 2009
Last Update Posted : March 12, 2012
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of Miami

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.

Condition or disease Intervention/treatment Phase
Living Donor Kidney Transplants Patients Drug: Tacrolimus, Myfortic and Sirolimus Phase 4

University of Miami has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Head to Head Comparison of Tacrolimus and Myfortic vs Tacrolimus and Sirolimus Used in Combination in Non-HLA Identical Living Donor Kidney Transplants
Study Start Date : January 2010
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Arm Intervention/treatment
Active Comparator: Tacrolimus and Myfortic
Drug: Tacrolimus, Myfortic and Sirolimus
Immunosuppressive drugs
Active Comparator: Tacrolimus and Sirolimus
Drug: Tacrolimus, Myfortic and Sirolimus
Immunosuppressive drugs

Primary Outcome Measures :
  1. The primary endpoint is the time to initiation of the comparison study [ Time Frame: 3 years ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01038505

Sponsors and Collaborators
University of Miami
Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Linda Chen, M.D. University of Miami

Responsible Party: Linda Chen, M.D., University of Miami Identifier: NCT01038505     History of Changes
Other Study ID Numbers: 20090531
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: March 12, 2012
Last Verified: December 2009

Additional relevant MeSH terms:
Immunosuppressive Agents
Mycophenolic Acid
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Antibiotics, Antitubercular
Antitubercular Agents