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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01033864
First Posted: December 17, 2009
Last Update Posted: August 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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 24.

Condition Intervention Phase
Kidney Transplantation Drug: MMF Drug: EC-MPS Drug: Prednisone Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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:
  • Pre-dose Trough Concentration (C0) [ Time Frame: Day 1 predose ]
    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 ]

    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 ]
    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 ]

    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 ]
    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 ]

    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 ]
    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 ]

    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 ]

Secondary Outcome Measures:
  • Regression Coefficients For Participants Receiving MMF [ Time Frame: Day 1 at 30 minutes and 1 and 2 hours postdose ]
    The estimated regression coefficients for participants who received MMF presented in milligrams per liter (mg/L).


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: 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.
Drug: MMF
1 g per day b.i.d. p.o. for at least 1 month
Other Names:
  • CellCept
  • mycophenolate mofetil
Drug: Prednisone
5 mg per day p.o.
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.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033864


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01033864     History of Changes
Other Study ID Numbers: ML22641
2009-012355-15
First Submitted: December 16, 2009
First Posted: December 17, 2009
Results First Submitted: May 8, 2014
Results First Posted: October 10, 2014
Last Update Posted: August 27, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Prednisone
Mycophenolic Acid
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action