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Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE4

Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients

Comparative Bioavailability of Myfenax® (Teva) and CellCept® (Roche) in Stable Patients After Renal Transplantation

NCT00991510•Teva Branded Pharmaceutical Products R&D, Inc.

Summary

The purpose of the study is to further investigate how much of the drug substance "mycophenolate mofetil" can be found in the blood of patients with kidney or renal transplants when treated with Myfenax® or CellCept®. Additionally, the safety and side effects of the two products will be compared. All information already available on these products indicates that the safety profiles of the two products will be the same.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Renal transplant recipients at least 12 months post-transplantation aged ≥ 18 years.
•Maintenance treatment with mycophenolate mofetil (in combination with tacrolimus with or without corticosteroids).
•Stable dose of mycophenolate mofetil (≥ 500 mg twice daily) with no changes in immunosuppressive regimen for at least 6 weeks prior to the start of the study.
•Stable renal graft function for at least 3 months.
•Female patients must be either post-menopausal for ≥ 1 year, be surgically sterilized or a negative pregnancy test will be required immediately prior to study entry and such patients must continue to use effective contraception.
•Willingness to undergo the study-related procedures.
•Ability to comprehend and willingness to sign informed consent form.

Exclusion Criteria

•History of allergy to mycophenolate mofetil, mycophenolic acid or any of the ingredients.
•Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any organ other than kidney.
•Rejection within the past 6 months prior to the start of the study.
•Severe clinically relevant co-existing disease.
•History of cancer other than skin cancer that has been cured.
•History of serious clinically relevant digestive system disease during the last 12 months prior to start of the study.
•Known or suspected hereditary deficiency of hypoxanthine-guanine-phosphoribosyltransferase (e.g., Lesch-Nyhan syndrome, Kelley-Seegmiller syndrome).
•Known or suspected liver impairment.
•Clinically significant thrombocytopenia, anaemia, leukopenia, or neutropenia
•Clinically significant laboratory and/or physical changes during the last 2 months prior to the start of the study.
+11 more criteria

Key Dates

Start Date

August 1, 2009

Primary Completion Date

October 1, 2010

Completion Date

October 1, 2010

Last Updated

November 8, 2018

Enrollment

ACTUAL participants

Conditions

Stable Renal Transplant Recipients

Interventions

mycophenolate mofetil (Myfenax)

DRUG

mycophenolate mofetil (Cellcept)

DRUG