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

NCT ID: NCT00991510

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-10-31

Brief 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.

Conditions

Stable Renal Transplant Recipients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reference/Test/Test

The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).

Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.

Group Type: EXPERIMENTAL

mycophenolate mofetil (Myfenax)

Intervention Type: DRUG

Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'T' (test drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil.

mycophenolate mofetil (Cellcept)

Intervention Type: DRUG

Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'R' (reference drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil.

Test/Reference/Reference

The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).

Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.

Group Type: EXPERIMENTAL

mycophenolate mofetil (Myfenax)

Intervention Type: DRUG

Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'T' (test drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil.

mycophenolate mofetil (Cellcept)

Intervention Type: DRUG

Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'R' (reference drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil.

Interventions

mycophenolate mofetil (Myfenax)

Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'T' (test drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil.

Intervention Type: DRUG

mycophenolate mofetil (Cellcept)

Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'R' (reference drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil.

Intervention Type: DRUG

Other Intervention Names

Myfenax®; CellCept®

Eligibility Criteria

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.
• Use of azathioprine, cholestyramine, sevelamer, or probenecid within 2 weeks prior to the first administration of study medication.
• Change in concomitant medication during the 6 weeks prior to start of the study.
• Use of any drug, prescribed or over-the-counter, (except stable concomitant medication) within 2 weeks prior to the first administration of study medication.
• Planned or expected requirement for the use of live attenuated vaccines during the study.
• Positive testing for HIV, Hepatitis B and C.
• Clinical symptoms or laboratory evidence of cytomegalovirus infection in the last 6 month.
• Pregnant or breast-feeding women.
• Women of childbearing potential unable or unwilling to practice effective contraceptive measures for the duration of the study and for 6 weeks after the end of the study.
• History of known or suspected alcohol or drug abuse.
• Any other condition of the patient that, in the opinion of the investigator may compromise evaluation of the study treatment or may jeopardize patient's compliance or adherence to protocol requirements.
• Previous enrollment in this study or participation in any other drug investigational trial within the past 6 weeks prior to enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gere Sunder-Plassman, Prof.,MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna

References

Sunder-Plassmann G et al.: Results of a Comparative Bioavailability Study of Myfenax (Teva) and CellCept (Roche) in Stable Kidney Transplant Recipients. American Transplant Congress 2011. Abstract Number: 250308

Reference Type: RESULT

Sunder-Plassmann G, Reinke P, Rath T, Wiecek A, Nowicki M, Moore R, Lutz J, Gaggl M, Ferkl M. Comparative pharmacokinetic study of two mycophenolate mofetil formulations in stable kidney transplant recipients. Transpl Int. 2012 Jun;25(6):680-6. doi: 10.1111/j.1432-2277.2012.01475.x. Epub 2012 Apr 16.

Reference Type: RESULT

PMID: 22500920 (View on PubMed)

Other Identifiers

2009-010562-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

116B8

Identifier Type: -

Identifier Source: org_study_id