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

Teva Pharmaceuticals

Status and phase: Terminated; Phase 4

Conditions: Stable Renal Transplant Recipients

Treatments: Drug: mycophenolate mofetil (Myfenax); Drug: mycophenolate mofetil (Cellcept)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00991510

116B8

2009-010562-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

43 participants in 2 patient groups

Reference/Test/Test

Experimental group

Description:

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.

Treatment:

Drug: mycophenolate mofetil (Cellcept)

Drug: mycophenolate mofetil (Myfenax)

Test/Reference/Reference

Experimental group

Description:

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.

Treatment:

Drug: mycophenolate mofetil (Cellcept)

Drug: mycophenolate mofetil (Myfenax)