- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01038505
Comparison of Tacrolimus and Myfortic Versus Tacrolimus and Sirolimus
March 9, 2012 updated by: University of Miami
Head to Head Comparison of Tacrolimus and Myfortic vs Tacrolimus and Sirolimus Used in Combination in Non-HLA Identical Living Donor Kidney Transplants
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
Phase
- Phase 4
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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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 |
---|---|
Active Comparator: Tacrolimus and Myfortic
Immunosuppressive
|
Immunosuppressive drugs
|
Active Comparator: Tacrolimus and Sirolimus
Immunosuppressive
|
Immunosuppressive drugs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint is the time to initiation of the comparison study
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Linda Chen, M.D., University of Miami
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
January 1, 2010
Primary Completion (Anticipated)
January 1, 2013
Study Completion (Anticipated)
January 1, 2013
Study Registration Dates
First Submitted
December 23, 2009
First Submitted That Met QC Criteria
December 23, 2009
First Posted (Estimate)
December 24, 2009
Study Record Updates
Last Update Posted (Estimate)
March 12, 2012
Last Update Submitted That Met QC Criteria
March 9, 2012
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Antitubercular Agents
- Antibiotics, Antitubercular
- Calcineurin Inhibitors
- Tacrolimus
- Mycophenolic Acid
- Sirolimus
Other Study ID Numbers
- 20090531
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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