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Head to Head Comparison of Myfortic vs. Cellcept in the Treatment of Kidney Transplant Recipients Using Our Current Center Standardized Concomitant Immunosuppressive Protocol

Phase 2/Phase 3
18 Years
75 Years
Not Enrolling
End Stage Renal Disease

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Trial Information

Head to Head Comparison of Myfortic vs. Cellcept in the Treatment of Kidney Transplant Recipients Using Our Current Center Standardized Concomitant Immunosuppressive Protocol

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

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.

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

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

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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).

Outcome Time Frame:

1 year

Principal Investigator

George W Burke, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami


United States: Institutional Review Board

Study ID:




Start Date:

December 2004

Completion Date:

February 2006

Related Keywords:

  • End Stage Renal Disease
  • Gastrointestinal toxicity
  • Kidney Diseases
  • Kidney Failure, Chronic



University Of Miami Miller School Of Medicine Miami, Florida  33010