Influence of Pantoprazole to the Bioavailability of Myfortic® and CellCept® | RxWiki

Influence of Pantoprazole to the Bioavailability of Myfortic® and CellCept®

Overview[ - collapse ][ - ]

Purpose	The object of this pharmakokinetic study is to analyze wether pantoprazole as a proton pump inhibitor influences the bioavailability of two different tablet formulations of mycophenolic acid applied either as mycophenolate mofetil or mycophenolate Sodium.
Condition	Immunosuppressive Medication After Renal Transplantation Concomitant Medication After Renal Transplantation
Intervention	Drug: Mycophenolate sodium Drug: Pantoprazole Drug: Mycophenolate mofetil
Phase	Phase 4
Sponsor	Klemens Budde
Responsible Party	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier	NCT01801280
First Received	February 13, 2013
Last Updated	February 26, 2013
Last verified	February 2013

Tracking Information[ + expand ][ + ]

First Received Date	February 13, 2013
Last Updated Date	February 26, 2013
Start Date	January 2012
Estimated Primary Completion Date	December 2013
Current Primary Outcome Measures	Bioavailability of mycophenolic acid (measured by AUC) [Time Frame: Study duration for each patient: 2 months. After 10-14 days of drug intake blood samples for full AUC will be collected and on the next day new treatment starts. Every patient has to visit the study centre four times for approximately 12 hours.] [Designated as safety issue: No]Evaluation of the bioavailability (as measured by 12h 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®. For pharmacokinetic and pharmacodynamic parameters 12 samples (before, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h after oral drug administration) from venous blood will be collected.
Current Secondary Outcome Measures	Analysis of additional pharmacokinetic parameters [Time Frame: Study duration for each patient: 2 months. After 10-14 days of drug intake blood samples for full AUC will be collected and on the next day new treatment starts. Every patient has to visit the study centre four times for approximately 12 hours.] [Designated as safety issue: No]Analysis of additional pharmacokinetic parameters, such as maximum concentration, average concentration, minimum concentration, time to Cmax, apparent clearance of mycophenolic acid and its metabolite mycophenolic acid glucuronide. Analysis of pharmacodynamic parameters [Time Frame: Study duration for each patient: 2 months. After 10-14 days of drug intake blood samples for full AUC will be collected and on the next day new treatment starts. Every patient has to visit the study centre four times for approximately 12 hours.] [Designated as safety issue: No]Analysis if IMPDH activity and the related pharmacodynamic parameters as maximum activity, minimum activity, average activity, maximum inhibition Analysis of safety and tolerability [Time Frame: Study duration for each patient: 2 months. After 10-14 days of drug intake every patient has to visit the study center 4 times for approximately 12 hours.] [Designated as safety issue: Yes]Analysis of safety and tolerability, in particular analysis of gastrointestinal discomfort (using two standardized questionnaires), infections, leucopenia, anemia, thrombocytopenia, renal function using serum creatinine and glomerular filtration rate (Cockcroft-Gault), ciclosporin blood levels (before and two hours after administration), incidence of biopsy-proven acute rejections and graft loss. Before oral drug administration additionally blood samples for blood chemistry, hematology and urine for urinalysis will be collected.

Descriptive Information[ + expand ][ + ]

Brief Title	Influence of Pantoprazole to the Bioavailability of Myfortic® and CellCept®
Official Title	Single Center, Open Label, Cross-over Study in Maintenance Renal Transplant Patients to Evaluate the Bioavailability of CellCept® (Mycophenolate Mofetil) in Comparison to Myfortic® (Enteric Coated Mycophenolate Sodium) With/Without the Proton Pump Inhibitor Pantozol® (Pantoprazole).
Brief Summary	The object of this pharmakokinetic study is to analyze wether pantoprazole as a proton pump inhibitor influences the bioavailability of two different tablet formulations of mycophenolic acid applied either as mycophenolate mofetil or mycophenolate Sodium.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Immunosuppressive Medication After Renal Transplantation Concomitant Medication After Renal Transplantation
Intervention	Drug: Mycophenolate sodium Daily dose: 720mg, 1080mg, 1440mg. Application either alone or together with Pantozol®. Other Names: Myfortic®Drug: Pantoprazole Daily dose: 40mg. Application together with either CellCept® or Myfortic® . Other Names: Pantozol®Drug: Mycophenolate mofetil Daily dose: 1000mg, 1500mg, 2000mg. Application either alone or with Pantozol® . Other Names: Cellcept®
Study Arm (s)	Other: C→ M → M+ P → C + P Mycophenolate mofetil (C) tablet twice a day every 12 hours for two weeks. Mycophenolate sodium (M) tablet twice a day every 12 hours for two weeks. Pantoprazole tablet (P) once a day in the morning for two weeks. Other: M → M + P → C + P → C Mycophenolate mofetil (C) tablet twice a day every 12 hours for two weeks. Mycophenolate sodium (M) tablet twice a day every 12 hours for two weeks. Pantoprazole tablet (P) once a day in the morning for two weeks. Other: M + P→ C + P → C→ M Mycophenolate mofetil (C) tablet twice a day every 12 hours for two weeks. Mycophenolate sodium (M) tablet twice a day every 12 hours for two weeks. Pantoprazole tablet (P) once a day in the morning for two weeks. Other: C+ P→ C → M→ M+ P Mycophenolate mofetil (C) tablet twice a day every 12 hours for two weeks. Mycophenolate sodium (M) tablet twice a day every 12 hours for two weeks. Pantoprazole tablet (P) once a day in the morning for two weeks.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	24
Estimated Completion Date	December 2013
Estimated Primary Completion Date	April 2013
Eligibility Criteria	Inclusion Criteria: - patients >18 years old - patients who are on stable immunosuppressive pre-treatment for at least one month with Cyclosporin A, Myfortic® or CellCept® with/without corticosteroids - renal transplantation, at least 6 months prior study inclusion - suitable and willing to switch treatment according to the study plan - 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%) Exclusion Criteria: - patients with renal function < 30ml/min (using Cockcroft Gault formula) - patients who are not on stable treatment with enzyme inductors or enzymes for one month before study start - 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 on treatment with clopidogrel - acute rejection < 1 month before study inclusion - patients who are HIV positive, hepatitis C virus (HCV) positive, HBsAg positive - patients with gastrointestinal disorders which could affect resorption - pregnancy and/or lactation - drug or alcohol abuse in patient's history - patients with a history of psychological illness or condition, so it might interfere with the patient's ability to understand the requirements, consequences, possible outcome of the study and patients who are not willing to give valid informed consent to the study - patients with insufficient co-operation with the clinical investigator (e.g. suspicion of non-compliance)
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Klemens Budde, Prof Dr +49 30 450 154 086 klemens.budde@charite.de
Location Countries	Germany

Administrative Information[ + expand ][ + ]

NCT Number	NCT01801280
Other Study ID Numbers	CERL 080A DE 20 T
Has Data Monitoring Committee	No
Information Provided By	Charite University, Berlin, Germany
Study Sponsor	Klemens Budde
Collaborators	Novartis Pharmaceuticals
Investigators	Principal Investigator: Klemens Budde, Prof Dr Charite University, Berlin, Germany
Verification Date	February 2013

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