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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 8, 2014
Last verified: October 2014

December 16, 2009
October 8, 2014
November 2009
June 2010   (final data collection date for primary outcome measure)
  • Pre-dose Trough Concentration (C0) [ Time Frame: Day 1 predose ] [ Designated as safety issue: No ]
    The mean mycophenolic acid (MPA) concentration in plasma was determined (in milligrams per liter [mg/L]) from blood samples collected predose (immediately before receiving study treatment).
  • Dose-Normalized C0 [ Time Frame: Day 1 predose ] [ Designated as safety issue: No ]

    Dose normalized C0 was determined (in mg/L) from blood samples collected predose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:

    For the MMF group: Dose normalized C0 equals (=) C0 divided by (/) (actual dose taken/1000) For the EC-MPS group: Dose normalized C0 = C0 / (actual dose taken/720)

  • Minimum Plasma Concentration (Cmin) [ Time Frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours ] [ Designated as safety issue: No ]
    The mean minimum MPA concentration in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1.
  • Dose-Normalized Cmin [ Time Frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours ] [ Designated as safety issue: No ]

    Dose-normalized Cmin was determined (in mg/L) from blood samples collected predose and postdose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:

    For the MMF group: Dose normalized Cmin = Cmin/ (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmin = Cmin / (actual dose taken/720)

  • Maximum Plasma Concentration (Cmax) [ Time Frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours ] [ Designated as safety issue: No ]
    The mean maximum MPA concentration in plasma was determined (in mg/L) in blood samples collected predose and postdose on Day 1.
  • Dose-Normalized Cmax (mg/L) [ Time Frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours ] [ Designated as safety issue: No ]

    Dose-normalized Cmax in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:

    For the MMF group: Dose normalized Cmax = Cmax / (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmax = Cmax / (actual dose taken/720)

  • MPA Area Under the Curve From 0 to 12 Hours (AUC0-12) [ Time Frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours ] [ Designated as safety issue: No ]
    The mean MPA AUC0-12 in plasma was determined (in mg multiplied by hours, per Liter [mg*h/L]) from blood samples collected predose and postdose on Day 1.
  • Dose-Normalized MPA AUC0-12 [ Time Frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours ] [ Designated as safety issue: No ]

    Dose-normalized MPA AUC0-12 in plasma was determined (mg*h/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:

    For the MMF group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/1000) For the EC-MPS group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/720)

  • Percentage of Participants By Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT01033864 on ClinicalTrials.gov Archive Site
Regression Coefficients For Participants Receiving MMF [ Time Frame: Day 1 at 30 minutes and 1 and 2 hours postdose ] [ Designated as safety issue: No ]
The estimated regression coefficients for participants who received MMF presented in milligrams per liter (mg/L).
Not Provided
Not Provided
Not Provided
 
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: MMF
    1 g per day b.i.d. p.o. for at least 1 month
    Other Names:
    • CellCept
    • mycophenolate mofetil
  • Drug: EC-MPS
    720 mg b.i.d. p.o. for at least 1 month
    Other Name: mycophenolate sodium
  • Drug: Prednisone
    5 mg per day p.o.
  • Experimental: MMF, Prednisone
    Participants received mycophenolate mofetil (MMF) orally (PO) at a dose of 1 gram per day (g/day) twice daily (BID), and prednisone, PO, up to 5 milligrams per day (mg/day) for at least 1 month.
    Interventions:
    • Drug: MMF
    • Drug: Prednisone
  • Active Comparator: EC-MPS
    Participants received mycophenolate sodium (EC-MPS), PO, at a dose of 720 mg/day BID, and prednisone PO up to 5 mg/day for at least 1 month.
    Interventions:
    • Drug: EC-MPS
    • Drug: Prednisone
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 2014

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