Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients

This study is currently recruiting participants.
Verified December 2013 by University of Cincinnati
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
E. Steve Woodle, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01336296
First received: October 28, 2010
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

This study is specifically designed to determine whether the initiation of Myfortic 2 weeks prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to Simulect induction will be compared to standard Myfortic therapy with Thymoglobulin induction starting at the time of transplant in kidney transplant recipients.


Condition Intervention Phase
Kidney Transplant Recipients
Drug: mycophenolic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12-month, Prospective, Randomized, Dual Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of Myfortic® (Mycophenolic Acid) Loading Regimens in Combination With Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)] or Simulect® (Basiliximab) Induction and Prograf® (Tacrolimus) in Early Corticosteroid Withdrawal

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Incidence of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Incidence of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) at 6 months.


Secondary Outcome Measures:
  • Severity of acute rejection by Banff '97 Criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Severity of acute rejection by Banff '97 Criteria. Acute cellular rejection Acute antibody mediated (humoral) rejection Proportion of patients requiring anti-lymphocyte therapy for acute rejection Incidence of chronic alloantibody rejection or chronic allograft arteriopathy by Banff '97 Criteria Change in creatinine clearance Urinary protein Incidence of denovo donor specific antibodies (DSA) Incidence of death, graft loss, delayed graft function (DGF), infection, and post-transplant malignancies.

    Patient and allograft survival



Estimated Enrollment: 75
Study Start Date: September 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Myfortic preload
Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)
Drug: mycophenolic acid
Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant
Active Comparator: Myfortic standard
Myfortic at time of transplant with Thymoglobulin induction
Drug: mycophenolic acid
Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients capable of understanding the purposes and risks of the study.
  • Patients who can give written informed consent, and who are willing and able to participate in the full course of the study.
  • Women of childbearing potential must have a negative serum pregnancy test within the last 48 hours prior to receiving study medication.
  • Women of childbearing potential must use two reliable forms of contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. Effective contraception must be used before beginning study drug therapy, for the duration of the study and for 6 weeks following completion of the study.

Exclusion Criteria:

  • Patients who are recipients of a multiple organ transplant or if the patient previously received and organ transplant.
  • Patients who are recipients of A-B-O incompatible transplants, all complement-dependent cytotoxicity (CDC) crossmatch positive transplants.
  • Sensitized patients [most recent anti-Human Leukocyte Antigens (HLA) Class I panel reactive antibody (PRA) ≥ 25% by a CDC-based assay].
  • Recipient or donor is known to be seropositive for hepatitis C virus (HCV) or B virus (HBV) except for hepatitis B surface antibody positive.
  • Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
  • Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
  • Patients with thrombocytopenia (<75,000/mm3 ), with an absolute neutrophil count of < 1,500/mm3); and/or leucopoenia (< 2,500/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
  • Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
  • Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil, enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.
  • Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication; diabetic patients with previously diagnosed diabetic gastroenteropathy, or patients with active peptic ulcer disease.
  • Patient is receiving chronic steroid therapy at the time of transplant.
  • Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin.
  • Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
  • 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.
  • Inability to cooperate or communicate with the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336296

Contacts
Contact: Adele Shields, Pharm.D. 513-558-0046 rikea@uc.edu
Contact: Lacey Thieken 513-558-0736 lacey.thieken@uc.edu

Locations
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Adele Shields, Pharm.D    513-558-0046    rikea@uc.edu   
Sponsors and Collaborators
University of Cincinnati
Novartis Pharmaceuticals
Investigators
Principal Investigator: Adele Shields, Pharm.D. University of Cincinnati
  More Information

No publications provided

Responsible Party: E. Steve Woodle, MD, FACS, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01336296     History of Changes
Other Study ID Numbers: Myfortic Preload
Study First Received: October 28, 2010
Last Updated: December 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Antilymphocyte Serum
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014