Comparison of Tacrolimus and Myfortic Versus Tacrolimus and Sirolimus

This study has been withdrawn prior to enrollment.
(Lost funding source)
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of Miami Identifier:
First received: December 23, 2009
Last updated: March 9, 2012
Last verified: December 2009

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 Intervention 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.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • The primary endpoint is the time to initiation of the comparison study [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tacrolimus and Myfortic
Drug: Tacrolimus, Myfortic and Sirolimus
Immunosuppressive drugs
Other Name: Tacrolimus, Myfortic and Sirolimus
Active Comparator: Tacrolimus and Sirolimus
Drug: Tacrolimus, Myfortic and Sirolimus
Immunosuppressive drugs
Other Name: Tacrolimus, Myfortic and Sirolimus

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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Linda Chen, M.D., University of Miami Identifier: NCT01038505     History of Changes
Other Study ID Numbers: 20090531
Study First Received: December 23, 2009
Last Updated: March 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Immunosuppressive Agents
Mycophenolate mofetil
Mycophenolic Acid
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents processed this record on April 17, 2014