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

December 16, 2009
October 7, 2013
November 2009
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01033864 on ClinicalTrials.gov Archive Site
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A Pharmacokinetic Study of CellCept (Mycophenolate Mofetil) Versus Mycophenolate Sodium in Kidney Transplant Patients
Comparison of Pharmocokinetics of Mycophenolate Mofetil and Enteric Coated Mycophenolate Sodium in Calcineurininhibitor-free Treated Patients After Renal Transplantation

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplantation
  • Drug: mycophenolate mofetil [CellCept]
    single oral dose (500mg tablets or 250mg capsules) as prescribed
  • Drug: mycophenolate sodium
    single oral dose (180mg or 360mg enteric coated tablets) as prescribed
  • Experimental: 1
    Intervention: Drug: mycophenolate mofetil [CellCept]
  • Active Comparator: 2
    Intervention: Drug: mycophenolate sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01033864
ML22641, 2009-012355-15
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP