Myfortic vs. Cellcept in Kidney Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00533624
First received: September 19, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

The comparison the incidence of G.I. toxicity between Myfortic® vs. Cellcept® in 150 sequential patients, in which 75 will be randomized to Cellcept® and 75 to Myfortic® in first and second living or deceased donor renal transplant recipients.


Condition Intervention Phase
End Stage Renal Disease
Drug: Mycophenolate Sodium Delayed Release Tablets
Drug: Mycophenolate Mofetil
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Head to Head Comparison of Myfortic vs. Cellcept in the Treatment of Kidney Transplant Recipients Using Our Current Center Standardized Concomitant Immunosuppressive Protocol

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Observation of G.I. toxicity (nausea, vomiting, or diarrhea). One year patient and graft survival after initiation of study agent.Incidence of biopsy-proven acute rejection (vide infra). 4. Incidence of chronic allograft nephropathy (vide infra). [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Incidence of AE: Infections, malignancies (including PTLD), thromboembolic events, hyperlipidemia and leuko and thrombocytopenia, cytokine release syndrome with induction antibody agents, wound healing and lymphocele, post-tx diabetes. [ Time Frame: 1 year ]

Enrollment: 150
Study Start Date: December 2004
Study Completion Date: February 2006
Arms Assigned Interventions
Active Comparator: 1: Myfortic
Myfortic Group: Myfortic® 1,440 mg/day in two divided doses (induced with either the IL-2 receptor inhibitors or thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml. Methylprednisolone is to be given as per our center protocols, weaning to dose levels of <0.1 mg/kg by 3-6 months post-operatively.
Drug: Mycophenolate Sodium Delayed Release Tablets
Myfortic® 1,440 mg/day
Active Comparator: 2. Cellcept
Cellcept® 2,000 mg/day, in divided doses (induced with either the IL-2 receptor inhibitors or thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml. Methylprednisolone is to be given as per our center protocols, weaning to dose levels of <0.1 mg/kg by 3-6 months post-operatively.
Drug: Mycophenolate Mofetil
Cellcept® 2,000 mg/day
Other Name: Cellcept®

Detailed Description:

Purpose and Description:

The purpose of the study is to determine if gastrointestinal toxicity of an anti-rejection medication Myfortic® (mycophenolic acid delayed release) is less than equivalent doses of a similar anti-rejection medication Cellcept® (mycophenolate mofetil, MMF) in patients receiving their first or second kidney transplant from cadaver or living donors.

This study consist of two randomized groups, 75 patients given 3 doses of Thymoglobullin (Group I) vs. 75 patients given 3 doses of Thymoglobulin and 2 doses of Basiliximab (Group II).

Our standard maintenance protocol dosing of tacrolimus, IMPDH inhibitor (vide infra) and one week course of corticosteroids.

Patients will be randomized to receive Myfortic® 1,440 mg/day vs. Cellcept® 2,000 mg/day, each in two divided doses (induced with either the IL-2 receptor inhibitors or thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml. Methylprednisolone is to be given as per our center protocols, weaning to dose levels of <0.1 mg/kg by 3-6 months post-operatively.

  Eligibility

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

Inclusion Criteria:

  1. Patient has been fully informed and has signed a dated IRB approval informed consent form and is willing to follow study procedures for the extent of the study (12 months). Parent or legal guardian must provide written consent for patients <18 years of age.
  2. Age 18-75 years.
  3. Weight > 40 kg.
  4. Primary or secondary renal allograft: living or deceased donor.
  5. Negative standard crossmatch for T cells.
  6. Women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception for the study duration.
  7. Males and females are to be studied equivalently as they become available for transplantation using these criteria.

Exclusion Criteria:

  1. Patient has previously received or is receiving an organ transplant other than a kidney.
  2. Patient is receiving an ABO incompatible donor kidney.
  3. Recipient or donor is seropositive for human immunodeficiency (HIV), Hepatitis C viruses, or Hepatitis B virus antigenemia.
  4. 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.
  5. 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 of this center.
  6. 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.
  7. Patient is currently participating in another clinical trial of an investigational drug in the 30 days prior to transplant.
  8. Patient will be receiving any immunosuppressive agent other than those prescribed in the study.
  9. 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) (Group I only).
  10. Patient is receiving or may require warfarin, fluvastatin, or herbal supplements during the study.
  11. Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole.
  12. Patient has a known hypersensitivity to tacrolimus, thymoglobulin, IL-2 receptor inhibitor monoclonal antibodies, sirolimus, MMF, Myfortic®, or corticosteroids.
  13. Patient is pregnant or lactating.
  14. 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.
  15. Patient is unlikely to comply with the visits scheduled in the protocol.
  16. 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533624

Locations
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Novartis
Investigators
Principal Investigator: George W Burke, M.D. University of Miami
  More Information

No publications provided by University of Miami

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00533624     History of Changes
Other Study ID Numbers: CERL080A-US10
Study First Received: September 19, 2007
Last Updated: September 19, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Gastrointestinal toxicity

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
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 July 10, 2014