Trial Outcomes & Findings for Effects of Mycophenolate Mofetil in Cystic Fibrosis Lung Transplant Patients (NCT NCT00908830)

Results Overview

The AUC is the area under the concentration-time curve from time 0 to 12 hours. The AUC is measured in units of micrograms of mycophenolic acid (MPA) per milliliter of plasma (mcg/mL) multiplied by time in hours (mg\*h/L) and in units of micrograms of mycophenolic acid glucuronide (MPAG) per milliliter of plasma (mcg/mL) multiplied by time in hours (mg\*h/L). Apparent oral clearance (CL/F) was calculated by dose/AUC0-12.

Recruitment status

COMPLETED

Target enrollment

10 participants

Primary outcome timeframe

0 hours pre-dose and again at 0.5, 1, 1.5, 2, 4, 6, 9, and 12 hours post-dose

Results posted on

2018-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Cystic Fibrosis Lung transplant patients with cystic fibrosis. Measuring MPA levels in cystic fibrosis lung transplant patients for pharmacokinetic parameters. mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil	Non-cystic Fibrosis Lung Transplant Non-cystic fibrosis lung transplant patients. Non-cystic fibrosis lung transplant patients will have MPA levels drawn after their dose to determine pharmacokinetic parameters. mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Mycophenolate Mofetil in Cystic Fibrosis Lung Transplant Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cystic Fibrosis n=5 Participants Lung transplant patients with cystic fibrosis. Measuring MPA levels in cystic fibrosis lung transplant patients for pharmacokinetic parameters. mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil	Non-cystic Fibrosis Lung Transplant n=5 Participants Non-cystic fibrosis lung transplant patients. Non-cystic fibrosis lung transplant patients will have MPA levels drawn after their dose to determine pharmacokinetic parameters. mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil	Total n=10 Participants Total of all reporting groups
Age, Continuous	30.6 years STANDARD_DEVIATION 6.8 • n=5 Participants	59.4 years STANDARD_DEVIATION 9.0 • n=7 Participants	45.0 years STANDARD_DEVIATION 16.9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 hours pre-dose and again at 0.5, 1, 1.5, 2, 4, 6, 9, and 12 hours post-dose

The AUC is the area under the concentration-time curve from time 0 to 12 hours. The AUC is measured in units of micrograms of mycophenolic acid (MPA) per milliliter of plasma (mcg/mL) multiplied by time in hours (mg\*h/L) and in units of micrograms of mycophenolic acid glucuronide (MPAG) per milliliter of plasma (mcg/mL) multiplied by time in hours (mg\*h/L). Apparent oral clearance (CL/F) was calculated by dose/AUC0-12.

Outcome measures

Outcome measures
Measure	Cystic Fibrosis n=5 Participants Lung transplant patients with cystic fibrosis. Measuring MPA levels in cystic fibrosis lung transplant patients for pharmacokinetic parameters. mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil	Non-cystic Fibrosis Lung Transplant n=5 Participants Non-cystic fibrosis lung transplant patients. Non-cystic fibrosis lung transplant patients will have MPA levels drawn after their dose to determine pharmacokinetic parameters. mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil
Steady-state Pharmacokinetics of Mycophenolic Acid and Mycophenolic Acid Glucuronide in Stable Cystic Fibrosis and Non-Cystic Fibrosis Lung Transplant Recipients. MPA AUC	47.7 mg*h/L Standard Error 13.7	83.1 mg*h/L Standard Error 27.9
Steady-state Pharmacokinetics of Mycophenolic Acid and Mycophenolic Acid Glucuronide in Stable Cystic Fibrosis and Non-Cystic Fibrosis Lung Transplant Recipients. MPAG AUC	569 mg*h/L Standard Error 204	911 mg*h/L Standard Error 249

SECONDARY outcome

Timeframe: 0 hours pre-dose and again at 0.5, 1, 1.5, 2, 4, 6, 9, and 12 hours post-dose

Inter- and intra-patient variability will be calculated by the coefficients of variation (CV) of the MPA AUC (mg\*h/L). To analyze the intra- and interindividual variability, the coefficient of variation (CV) was calculated by dividing the standard deviation by the mean of the PK parameters from the 3 PK visits and the 5 study patients in each group, respectively. Inter-individual CVs presented are only comparing within the individuals per arm, not across or between arms.

Outcome measures

Outcome measures
Measure	Cystic Fibrosis n=5 Participants Lung transplant patients with cystic fibrosis. Measuring MPA levels in cystic fibrosis lung transplant patients for pharmacokinetic parameters. mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil	Non-cystic Fibrosis Lung Transplant n=5 Participants Non-cystic fibrosis lung transplant patients. Non-cystic fibrosis lung transplant patients will have MPA levels drawn after their dose to determine pharmacokinetic parameters. mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil
Inter- and Intra-patient Variability of Mycophenolic Acid Exposure (AUC) in Cystic Fibrosis Lung Transplant Recipients on Tacrolimus Based Immunosuppression. MPA AUC..Intraindividual	16.6 percent CV Standard Deviation 6.1	13.8 percent CV Standard Deviation 5.3
Inter- and Intra-patient Variability of Mycophenolic Acid Exposure (AUC) in Cystic Fibrosis Lung Transplant Recipients on Tacrolimus Based Immunosuppression. MPA AUC..Interindividual	31.2 percent CV Standard Deviation 1.5	36.3 percent CV Standard Deviation 5.6
Inter- and Intra-patient Variability of Mycophenolic Acid Exposure (AUC) in Cystic Fibrosis Lung Transplant Recipients on Tacrolimus Based Immunosuppression. MPAG AUC..Intraindividual	16.6 percent CV Standard Deviation 6.5	15.9 percent CV Standard Deviation 6.7
Inter- and Intra-patient Variability of Mycophenolic Acid Exposure (AUC) in Cystic Fibrosis Lung Transplant Recipients on Tacrolimus Based Immunosuppression. MPAG AUC..Interindividual	37.3 percent CV Standard Deviation 6.1	27.8 percent CV Standard Deviation 3.2

Adverse Events

Cystic Fibrosis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-cystic Fibrosis Lung Transplant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Linda Stuckey, Pharm.D

University of Michigan Health System

Phone: 734-936-8129

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place