A Pharmacokinetic Study of CellCept (Mycophenolate Mofetil) Versus Mycophenolate Sodium in Kidney Transplant Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01033864
First received: December 16, 2009
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

This open-label, 2-arm study will compare the pharmacokinetics of CellCept and mycophenolate sodium in kidney transplanted patients on a calcineurininhibitor-free mycophenolic acid-based therapy. On the study day patients will take their prescribed medication (either CellCept or mycophenolate sodium). Blood samples will be drawn directly before and at intervals up to 12 hours after intake of the study medication. Anticipated time on study treatment is 12 hours and target sample size is >30.


Condition Intervention Phase
Kidney Transplantation
Drug: mycophenolate mofetil [CellCept]
Drug: mycophenolate sodium
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Pharmocokinetics of Mycophenolate Mofetil and Enteric Coated Mycophenolate Sodium in Calcineurininhibitor-free Treated Patients After Renal Transplantation

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics of CellCept versus mycophenolate sodium: Cmax, Tmax, C0, Cmin, AUC0-12 [ Time Frame: sampling predose and at 20, 40 and 75 minutes and 2, 3, 4, 6, 8, 10 and 12 hours after intake ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: November 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: mycophenolate mofetil [CellCept]
single oral dose (500mg tablets or 250mg capsules) as prescribed
Active Comparator: 2 Drug: mycophenolate sodium
single oral dose (180mg or 360mg enteric coated tablets) as prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >/=18 years of age
  • kidney transplantation >/=6 months ago
  • on mycophenolic acid-based, calcineurininhibitor-free therapy for >/=3 months, >/=1 month on stable dose
  • co-therapy with 5mg prednisone for >/=1 month

Exclusion Criteria:

  • active gastrointestinal ulcus
  • severe diarrhea od gastrointestinal disease
  • severe impairment of renal function
  • current malignancy
  • Lesch-Nyhan- or Kelley-Seegmiller-Syndrome
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033864

Locations
Germany
Frankfurt Am Main, Germany, 60528
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01033864     History of Changes
Other Study ID Numbers: ML22641, 2009-012355-15
Study First Received: December 16, 2009
Last Updated: October 7, 2013
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014