Comparison of Tacrolimus and Myfortic Versus Tacrolimus and Sirolimus

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University of Miami

Status and phase

Withdrawn
Phase 4

Conditions

Living Donor Kidney Transplants Patients

Treatments

Drug: Tacrolimus, Myfortic and Sirolimus

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01038505
20090531

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Tacrolimus and Myfortic
Active Comparator group
Description:
Immunosuppressive
Treatment:
Drug: Tacrolimus, Myfortic and Sirolimus
Tacrolimus and Sirolimus
Active Comparator group
Description:
Immunosuppressive
Treatment:
Drug: Tacrolimus, Myfortic and Sirolimus

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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