immunosuppressive regime in stable renal transplant recipients MedDRA version: 9.1 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection
Conditions
Interventions
Trade Name: Myfenax 500 mg
Pharmaceutical Form: Tablet
Trade Name: CellCept 500 mg
Pharmaceutical Form: Tablet
Trade Name: Myfenax 250 mg
Pharmaceutical Form: Capsule*
Trade Name: CellCept 250 mg
P
Sponsors
TEVA Pharmaceuticals Europe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only subjects who meet all of the following criteria are to be included in the study: - Male and female 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 (with serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria are to be excluded from study participation: - History of hypersensitivity to mycophenolate mofetil, mycophenolic acid or any of the excipients. - Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney. - Rejection episode within the past 6 months prior to the start of the study. - Severe clinically relevant co-existing disease (e.g. severe and uncontrolled cardiac disease, endocrine disease, acute or chronic infection or uncontrolled hypertension). - History of malignant lymphoma / lymphoproliferative disorder or other malignancy (during the past 5 years, except for cutaneous tumours considered cured). - History of serious clinically relevant digestive system disease during the last 12 months prior to start of the study. Mild GI symptoms as an undesirable effect of mycophenolate medication are not an exclusion criterion. - Known or suspected hereditary deficiency of hypoxanthine-guanine-phosphoribosyl-transferase (e.g. Lesch-Nyhan syndrome, Kelley-Seegmiller syndrome). - Known or suspected significant hepatic impairment (hepatic transaminases >3 times the upper limit of normal). - Clinically significant thrombocytopenia (<75,000 cells/mm3), anaemia (haemoglobin <6 g/dl), leukopenia (<2,500 cells/mm3), or neutropenia (absolute neutrophil count <1,500 cells/mm3) at screening. - Clinically significant laboratory and/or physical changes during the last 2 months prior to the start of the study. - Use of azathioprine, cholestyramine (or any other drug known to interfere with enterohepatic recirculation), sevelamer, or probenecid within 2 weeks prior to the first administration of study medication. - Change in concomitant medication (especially drugs known to affect the pharmacokinetics of mycophenolate mofetil, mycophenolic acid) during the 6 weeks prior to start of the study. - Use of any drug, prescribed or over-the-counter, (except stable concomitant medication) during the 2 weeks prior to the first administration of study medication except where, in the opinion of the clinical investigator, this will not affect the outcome of the study. - Planned or expected requirement for the use of live attenuated vaccines during the study. - Positive testing for HIV, HBsAg, or HCV. - Clinical symptoms or laboratory evidence of CMV infection in the last 6 month, if considered clinically relevant by the investigator. - Pregnancy or breast feeding. 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 enrolment in this study or participation in any other drug investigational trial within the past 6 weeks (or five half-lives whatever is longer) prior to enrolment. - Persons housed in an institution on the basis of a court order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare steady state pharmacokinetics of mycophenolate mofetil after multiple dose administration of Myfenax and CellCept;Secondary Objective: evaluation of clinical safety and efficacy of the two products;Primary end point(s): AUC (area under the plasma concentration-time curve during a dosage interval at steady state) Cmax (maximum plasma concentration) | — |
Countries
Austria, Germany, Poland, United Kingdom
Outcome results
None listed