Trial Outcomes & Findings for A Pharmacokinetic Study of CellCept (Mycophenolate Mofetil) Versus Mycophenolate Sodium in Kidney Transplant Patients (NCT NCT01033864)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

Day 1 predose

Results posted on

2015-08-27

Participant Flow

Participant milestones

Participant milestones
Measure	Mycophenolate Mofetil (MMF)/Prednisone Participants were administered MMF tablets or capsules, orally (PO), at a dose prescribed by their physician and prednisone up to 5 milligrams (mg) PO on Day 1.	Enteric-coated Mycophenolate Sodium (EC-MPS)/Prednisone Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
Overall Study STARTED	12	11
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MMF/Prednisone n=12 Participants Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.	EC-MPS/Prednisone n=11 Participants Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.	Total n=23 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 11.06 • n=5 Participants	58.0 years STANDARD_DEVIATION 8.04 • n=7 Participants	59.8 years STANDARD_DEVIATION 9.68 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 predose

Population: Pharmacokinetic (PK) population: all participants who took study drug and for whom all defined blood samples at the planned sampling time points were available.

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).

Outcome measures

Outcome measures
Measure	MMF/Prednisone n=12 Participants Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.	EC-MPS/Prednisone n=11 Participants Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
Pre-dose Trough Concentration (C0)	2.387 mg/L Standard Deviation 1.1327	2.944 mg/L Standard Deviation 2.2103

PRIMARY outcome

Timeframe: Day 1 predose

Population: PK population

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)