Single center, open-label, cross-over study in maintenace kidney allograft recipients to evaluate the bioavailability of CellCept® (Mycophenolate mofetil) in comparison to Myfortic® (Enteric- coated mycophenolate sodium) in combination with a proton pump inhibitor without co-medication. - Not available

Phase 1

• Conditions: Prophylaxis against renal transplant rejectionRenal transplant -> immunosuppressant drug therapy; MedDRA version: 12.1Level: LLTClassification code 10054980Term: Immunosuppressant drug therapy; MedDRA version: 12.1Level: LLTClassification code 10038533Term: Renal transplant; MedDRA version: 12.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejection

• Registration Number: EUCTR2010-021275-92-DE
• Lead Sponsor: Charité – Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-01
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

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 <1%).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified