Comparison of Tacrolimus and Myfortic Versus Tacrolimus and Sirolimus

NCT01038505 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 20090531
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Living Donor Kidney Transplants Patients

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the time to initiation of the comparison study

  3 years

Study Arms (2)

Tacrolimus and Myfortic

ACTIVE COMPARATOR

Immunosuppressive

Drug: Tacrolimus, Myfortic and Sirolimus

Tacrolimus and Sirolimus

ACTIVE COMPARATOR

Immunosuppressive

Drug: Tacrolimus, Myfortic and Sirolimus

Interventions

Tacrolimus, Myfortic and Sirolimus DRUG

Immunosuppressive drugs

Tacrolimus and Myfortic; Tacrolimus and Sirolimus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-HLA identical living donor kidney transplant patients

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

MeSH Terms

Interventions

Tacrolimus; Mycophenolic Acid; Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Officials

• Linda Chen, M.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 24, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 3, 2024

Record last verified: 2024-05