Comparison of Tacrolimus and Myfortic Versus Tacrolimus and Sirolimus

NCT01038505

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Living Donor Kidney Transplants Patients
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Non-HLA identical living donor kidney transplant patients

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Living Donor Kidney Transplants PatientsComparison of Tacrolimus and Myfortic Versus Tacrolimus and Sirolimus
NCT01038505
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Comparison of Tacrolimus and Myfortic Versus Tacrolimus and Sirolimus
Official Title  ICMJE Head to Head Comparison of Tacrolimus and Myfortic vs Tacrolimus and Sirolimus Used in Combination in Non-HLA Identical Living Donor Kidney Transplants
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Living Donor Kidney Transplants Patients
Intervention  ICMJE Drug: Tacrolimus, Myfortic and Sirolimus
Immunosuppressive drugs
Study Arms  ICMJE
  • Active Comparator: Tacrolimus and Myfortic
    Immunosuppressive
    Intervention: Drug: Tacrolimus, Myfortic and Sirolimus
  • Active Comparator: Tacrolimus and Sirolimus
    Immunosuppressive
    Intervention: Drug: Tacrolimus, Myfortic and Sirolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 9, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2009)
150
Estimated Study Completion Date  ICMJE January 2013
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01038505
Other Study ID Numbers  ICMJE 20090531
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Linda Chen, M.D., University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Linda Chen, M.D.University of Miami
PRS Account University of Miami
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP