Prophylaxis against renal transplant rejection Renal transplant -> immunosuppressant drug therapy MedDRA version: 12.1 Level: LLT Classification code 10054980 Term: Immunosuppressant drug therapy MedDRA version: 12.1 Level: LLT Classification code 10038533 Term: Renal transplant MedDRA version: 12.1 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection
Conditions
Interventions
Trade Name: Myfortic®
Product Name: Myfortic®
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: MYCOPHENOLATE SODIUM
CAS Number: 37415-62-6
Concentration unit: mg milligram(s)
Concentr
Sponsors
Charité – Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients who are at least 18 years of age, • Willing to provide informed consent, • Suitable and willing to switch treatment according to the study plan, • Patients who are on stable immunosuppressive pre-treatment for at least one month with Cyclosporin A (C0-level of 75-150 ng/mL or C2-level of 400-900 ng/mL), Myfortic® or Cellcept® with or without corticosteroids , • Renal transplantation, at least 6 months prior to study inclusion, • Women of childbearing potential must have a negative serum pregnancy test before study start, and effective contraception must be used (method with PEARL index =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Known anamnestic hypersensitivity to one of the investigational products or drugs with similar chemical structure and to other components of the investigational products, respectively, • Patients who are not on stable treatment with enzyme inductors or enzymes for one month before study start, • Patients with renal function <30mL/min (using the Cockroft-Gault formula), • Patients on treatment with clopidogrel, • Acute rejection less than 1 month before study inclusion, • Patients who are HIV positive, HCV positive or HBsAg positive , • Patients with gastrointestinal disorders which could affect resorption, • Pregnancy and/or lactation, • Drug or alcohol abuse in the patient’s history, • (Patients with) insufficient co-operation with the clinical investigator (e.g. suspicion of non-compliance), • Patients with a history of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements, the consequences and possible outcomes of the study and who are not willing to give a valid informed consent to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study objectives: The objective of this pharmacokinetic trial is to analyze, whether the concomitant administration of a proton pump inhibitor influences the bioavailability of mycophenolic acid, applied as either mycophenolat mofetil or enteric-coated mycophenolic acid. Primary objective: Evaluation of the bioavailability (as measured by area-under-the-concentration-curve (AUC)) of mycophenolic acid in stable renal transplant patients under immunosuppressive maintenance therapy after application of CellCept® alone or in combination with pantozol®; myfortic® alone or in combination with pantozol®.;Secondary Objective: • Analysis of additional pharmacokinetic parameters, such as maximal concentration (Cmax), average concentration (Cavg), minimal concentration (Cmin), time to Cmax (Tmax), and apparent clearance (CL/F) of mycophenolic acid (MPA), • Analysis of the pharmacokinetic characteristics of the MPA metabolite MPAG, • Analysis of IMPH activity and the related pharmacodynamic (PD) parameters (maximal activity (Emax), minimal activity (Emax), average activity (Aavg), maximal inhibition), • Analysis of the safety and tolerability, in particular analysis of gastrointestinal discomfort (using standardized questionnaires), infections, leukopenia, anemia, thrombocytopenia, liver enzymes (AST, ALT), albumin- and protein content, gastrointestinal AEs incl. intensity, renal function using serum creatinine and GFR (according to Nanikvell and Cockroft-Gault), incidence of biopsy-proven acute rejections, and graft loss. ;Primary end point(s): Evaluation of the bioavailability (as measured by area-under-the-concentration-curve (AUC)) of mycophenolic acid in stable renal transplant patients under immunosuppressive maintenance therapy after application of CellCept® alone or in combination with pantozol®; myfortic® alone or in combination with pantozol®. | — |
Countries
Germany
Outcome results
None listed