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

NCT01033864 | Completed Phase 4 Results

• 2 other identifiers: ML226412009-012355-15
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (9)

• Pre-dose Trough Concentration (C0)

  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).

  Day 1 predose

• Dose-Normalized C0

  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)

  Day 1 predose

• Minimum Plasma Concentration (Cmin)

  The mean minimum MPA concentration in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1.

  Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours

• Dose-Normalized Cmin

  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)

  Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours

• Maximum Plasma Concentration (Cmax)

  The mean maximum MPA concentration in plasma was determined (in mg/L) in blood samples collected predose and postdose on Day 1.

  Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours

• Dose-Normalized Cmax (mg/L)

  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)

  Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours

• MPA Area Under the Curve From 0 to 12 Hours (AUC0-12)

  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.

  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

  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)

  Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours

• Percentage of Participants By Time to Maximum Plasma Concentration (Tmax)

  Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours

Secondary Outcomes (1)

• Regression Coefficients For Participants Receiving MMF

  Day 1 at 30 minutes and 1 and 2 hours postdose

Study Arms (2)

MMF, Prednisone

EXPERIMENTAL

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; Drug: Prednisone

EC-MPS

ACTIVE COMPARATOR

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; Drug: Prednisone

Interventions

MMF DRUG

1 g per day b.i.d. p.o. for at least 1 month

Also known as: CellCept, mycophenolate mofetil

MMF, Prednisone

EC-MPS DRUG

720 mg b.i.d. p.o. for at least 1 month

Also known as: mycophenolate sodium

EC-MPS

Prednisone DRUG

5 mg per day p.o.

EC-MPS; MMF, Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• active gastrointestinal ulcus
• severe diarrhea od gastrointestinal disease
• severe impairment of renal function
• current malignancy
• Lesch-Nyhan- or Kelley-Seegmiller-Syndrome

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Frankfurt am Main, 60528, Germany

Location

MeSH Terms

Interventions

Mycophenolic Acid; Prednisone

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 27, 2015
• Results First Posted: October 10, 2014

Record last verified: 2015-08

Locations

DE (1)