Lung TransplantationPhase 3NCT01014442

A Study of Mycophenolate Mofetil (CellCept) in Lung Transplant Recipients

A Phase 3 study testing mycophenolate mofetil in people with Lung Transplantation, run by Hoffmann-La Roche at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Transplantation
What is being tested?: mycophenolate mofetil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteGermany
Study dates: Jan 2010to Jun 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

primary single or bilateral lung allograft
original disease cystic fibrosis, COPD, emphysema, idiopathic pulmonary fibrosis or A1AD

Who cannot join

lung allograft retransplantation
multiple organ transplantation
severe gastrointestinal disorder
malignancies or history of malignancy

Trial locations and contacts

1 site in 1 country.

Germany1 site

Department of Cardiothoracic, Transplantation and Vascular Surgery at Hannover Medical School
Hanover, 30625

Other trials in Germany

About this study

Official title: Pharmacokinetics of Mycophenolate Mofetil in de Novo Lung Allograft Recipients

This open-label, single center study will assess the pharmacokinetics, efficacy and safety of mycophenolate mofetil in lung allograft recipients. Participants will be split into 2 groups according to the original disease: Group A (cystic fibrosis) and Group B (chronic obstructive pulmonary disease [COPD], emphysema, idiopathic pulmonary fibrosis, alpha-1 antitrypsin deficiency [A1AD]). All participants will receive mycophenolate mofetil orally, 1.5 grams (g) twice daily (BID) from Day 2 to 30 post transplantation, and 1 g BID from Day 31 to 90 post transplantation. Anticipated time on study treatment is 90 days, and target sample size is 50-100 individuals.

Conditions: Lung Transplantation
Being tested: mycophenolate mofetil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mycophenolate mofetilDrug
Also called CellCept
1.5 g PO BID from Days 2 to 30 post-transplantation, 1 g PO BID Days 31 to 90 post-transplantation

Study groups in NCT01014442
Study group	Role	What they receive
Mycophenolate Mofetil; Cystic Fibrosis	Experimental	Participants with cystic fibrosis will receive mycophenolate mofetil 1.5 g, orally (PO), BID from Days 2 through 30 post-transplantation, and 1 g, PO, BID from Days 31 through 90 post-transplantation. Receives: Drug: mycophenolate mofetil
Mycophenolate Mofetil; Other	Experimental	Participants with COPD, emphysema, idiopathic pulmonary fibrosis, or A1AD will receive mycophenolate mofetil 1.5 g, PO, BID, from Days 2 through 30 post-transplantation, and 1 g, PO, BID from Days 31 through 90 post-transplantation. Receives: Drug: mycophenolate mofetil

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4
Cmax was expressed in milligrams per liter (mg/L).
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 after transplantation
Cmax of MPA, MPAG and AcMPAG at Day 8
Cmax was expressed in mg/L.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Cmax of MPA, MPAG and AcMPAG at Day 20
Cmax was expressed in mg/L.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Cmax of MPA, MPAG and AcMPAG at Day 90
Cmax was expressed in mg/L.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Cmax of Free MPA at Day 4
Cmax was expressed in micrograms per liter (mcg/L).
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
Cmax of Free MPA at Day 8
Cmax was expressed in mcg/L.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Cmax of Free MPA at Day 20
Cmax was expressed in mcg/L.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Cmax of Free MPA at Day 90
Cmax was expressed in mcg/L.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4
Dose-normalized Cmax was determined (in 1 per liter [1/L]) by dividing the Cmax by the actual dose taken.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8
Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 20
Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 90
Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Time to Maximum Concentration (Tmax) of MPA, MPAG, AcMPAG and Free MPA at Day 4
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 8
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 20
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 90
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Minimum Concentration (Cmin) of MPA, MPAG and AcMPAG at Day 4
Cmin was expressed in mg/L.
Measured: Predose (0 hour) on Day 4 post-transplantation
Cmin of MPA, MPAG and AcMPAG at Day 8
Cmin was expressed in mg/L.
Measured: Predose (0 hour) on Day 8 post-transplantation
Cmin of MPA, MPAG and AcMPAG at Day 20
Cmin was expressed in mg/L.
Measured: Predose (0 hour) on Day 20 post-transplantation
Cmin of MPA, MPAG and AcMPAG at Day 90
Cmin was expressed in mg/L.
Measured: Predose (0 hour) on Day 90 post-transplantation
Cmin of Free MPA at Day 4
Cmin was expressed in mcg/L.
Measured: Predose (0 hour) on Day 4 post-transplantation
Cmin of Free MPA at Day 8
Cmin was expressed in mcg/L.
Measured: Predose (0 hour) on Day 8 post-transplantation
Cmin of Free MPA at Day 20
Cmin was expressed in mcg/L.
Measured: Predose (0 hour) on Day 20 post-transplantation
Cmin of Free MPA at Day 90
Cmin was expressed in mcg/L.
Measured: Predose (0 hour) on Day 90 post-transplantation
Volume of Distribution (Vz) of MPA, MPAG and AcMPAG at Day 4
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
Vz of MPA, MPAG and AcMPAG at Day 8
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Vz of MPA, MPAG and AcMPAG at Day 20
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Vz of MPA, MPAG and AcMPAG at Day 90
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Clearance (CL) of MPA, MPAG and AcMPAG at Day 4
CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in liters per hour (L/hour).
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
CL of MPA, MPAG and AcMPAG at Day 8
CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
CL of MPA, MPAG and AcMPAG at Day 20
CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
CL of MPA, MPAG and AcMPAG at Day 90
CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of MPA, MPAG and AcMPAG at Day 4
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours time milligrams per liter (hours*[mg/L]).
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
AUC0-12 of MPA, MPAG and AcMPAG at Day 8
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
AUC0-12 of MPA, MPAG and AcMPAG at Day 20
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
AUC0-12 of MPA, MPAG and AcMPAG at Day 90
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
AUC0-12 of Free MPA at Day 4
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours times micrograms per liter (hours*[mcg/L]).
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
AUC0-12 of Free MPA at Day 8
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
AUC0-12 of Free MPA at Day 20
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
AUC0-12 of Free MPA at Day 90
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 4
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 8
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 20
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 90
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Free Fraction of Free MPA at Day 4
MPA Free fraction (in percent [%]) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
Free Fraction of Free MPA at Day 8
MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Free Fraction of Free MPA at Day 20
MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Free Fraction of Free MPA at Day 90
MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.
Measured: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

Secondary outcomes (6)

Forced Expiratory Volume in 1 Second (FEV1) at Day 90 Post-Transplantation
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Measured: Day 90 post-transplantation
Percent of Predicted FEV1 at Day 90 Post-Transplantation
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Percent predicted FEV1 [%] = (FEV1 [L] / Predicted normal value FEV1 [L]) * 100%
Measured: Day 90 post-transplantation
Forced Vital Capacity (FVC) at Day 90 Post-Transplantation
FVC at Day 90 post-transplantation is reported.
Measured: Day 90 post-transplantation
Change From Baseline in Intracellular Adenosine-Tri-Phosphate (iATP) Levels
iATP was expressed in ng/mL.
Measured: Baseline, Days 4, 8, 20 and 90 post-transplantation
Change From Baseline in T-Cell Phenotype
Reported values are change in the T-cell phenotype status from baseline to Day 20 and 90 for cluster of differentiation (CD) 3, CD19, CD4, CD4CD25, CD28, CD45RA, CD45RO, CD69, CD127, and CD152.
Measured: Baseline, Days 20 and 90 post-transplantation
Percentage of Participants With Opportunistic Infections
Opportunistic infections included all infections which occurred due to aspergillus, candida, pneumocystis, cryptococcus, listeria, herpes zoster, herpes simplex, cytomegalovirus pathogens.
Measured: Up to Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Jun 2012

First posted17 Nov 2009 (estimated)
Study startJan 2010
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung TransplantationStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01014442
Sponsor's protocol ID: ML22608
Other IDs: 2009-012231-15, 2009
Status last verified: Jul 2015
First submitted: 16 Nov 2009
Last updated: 10 Feb 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of Mycophenolate Mofetil in de Novo Lung Allograft Recipients
ClinicalTrials.gov ID: NCT01014442
Acronym / sponsor ID: ML22608
Conditions: Lung Transplantation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 17 Nov 2009 (estimated)
Results: Posted 10 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mycophenolate Mofetil; Cystic Fibrosis	Experimental	Drug: mycophenolate mofetilParticipants with cystic fibrosis will receive mycophenolate mofetil 1.5 g, orally (PO), BID from Days 2 through 30 post-transplantation, and 1 g, PO, BID from Days 31 through 90 post-transplantation.
Mycophenolate Mofetil; Other	Experimental	Drug: mycophenolate mofetilParticipants with COPD, emphysema, idiopathic pulmonary fibrosis, or A1AD will receive mycophenolate mofetil 1.5 g, PO, BID, from Days 2 through 30 post-transplantation, and 1 g, PO, BID from Days 31 through 90 post-transplantation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

primary single or bilateral lung allograft
original disease cystic fibrosis, COPD, emphysema, idiopathic pulmonary fibrosis or A1AD

Key exclusion criteria (4 listed)

lung allograft retransplantation
multiple organ transplantation
severe gastrointestinal disorder
malignancies or history of malignancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mycophenolate mofetilAlso: CellCept1.5 g PO BID from Days 2 to 30 post-transplantation, 1 g PO BID Days 31 to 90 post-transplantation	Drug	Mycophenolate Mofetil; Cystic Fibrosis, Mycophenolate Mofetil; Other

Primary outcome

Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 after transplantation
Cmax was expressed in milligrams per liter (mg/L).
Cmax of MPA, MPAG and AcMPAG at Day 8
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Cmax was expressed in mg/L.
Cmax of MPA, MPAG and AcMPAG at Day 20
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Cmax was expressed in mg/L.
Cmax of MPA, MPAG and AcMPAG at Day 90
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Cmax was expressed in mg/L.
Cmax of Free MPA at Day 4
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
Cmax was expressed in micrograms per liter (mcg/L).
Cmax of Free MPA at Day 8
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Cmax was expressed in mcg/L.
Cmax of Free MPA at Day 20
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Cmax was expressed in mcg/L.
Cmax of Free MPA at Day 90
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Cmax was expressed in mcg/L.
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
Dose-normalized Cmax was determined (in 1 per liter [1/L]) by dividing the Cmax by the actual dose taken.
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 20
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.
Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 90
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.
Time to Maximum Concentration (Tmax) of MPA, MPAG, AcMPAG and Free MPA at Day 4
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 8
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 20
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 90
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Minimum Concentration (Cmin) of MPA, MPAG and AcMPAG at Day 4
Time frame: Predose (0 hour) on Day 4 post-transplantation
Cmin was expressed in mg/L.
Cmin of MPA, MPAG and AcMPAG at Day 8
Time frame: Predose (0 hour) on Day 8 post-transplantation
Cmin was expressed in mg/L.
Cmin of MPA, MPAG and AcMPAG at Day 20
Time frame: Predose (0 hour) on Day 20 post-transplantation
Cmin was expressed in mg/L.
Cmin of MPA, MPAG and AcMPAG at Day 90
Time frame: Predose (0 hour) on Day 90 post-transplantation
Cmin was expressed in mg/L.
Cmin of Free MPA at Day 4
Time frame: Predose (0 hour) on Day 4 post-transplantation
Cmin was expressed in mcg/L.
Cmin of Free MPA at Day 8
Time frame: Predose (0 hour) on Day 8 post-transplantation
Cmin was expressed in mcg/L.
Cmin of Free MPA at Day 20
Time frame: Predose (0 hour) on Day 20 post-transplantation
Cmin was expressed in mcg/L.
Cmin of Free MPA at Day 90
Time frame: Predose (0 hour) on Day 90 post-transplantation
Cmin was expressed in mcg/L.
Volume of Distribution (Vz) of MPA, MPAG and AcMPAG at Day 4
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Vz of MPA, MPAG and AcMPAG at Day 8
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Vz of MPA, MPAG and AcMPAG at Day 20
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Vz of MPA, MPAG and AcMPAG at Day 90
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Clearance (CL) of MPA, MPAG and AcMPAG at Day 4
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in liters per hour (L/hour).
CL of MPA, MPAG and AcMPAG at Day 8
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.
CL of MPA, MPAG and AcMPAG at Day 20
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.
CL of MPA, MPAG and AcMPAG at Day 90
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.
Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of MPA, MPAG and AcMPAG at Day 4
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours time milligrams per liter (hours*[mg/L]).
AUC0-12 of MPA, MPAG and AcMPAG at Day 8
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).
AUC0-12 of MPA, MPAG and AcMPAG at Day 20
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).
AUC0-12 of MPA, MPAG and AcMPAG at Day 90
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).
AUC0-12 of Free MPA at Day 4
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours times micrograms per liter (hours*[mcg/L]).
AUC0-12 of Free MPA at Day 8
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).
AUC0-12 of Free MPA at Day 20
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).
AUC0-12 of Free MPA at Day 90
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 4
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 8
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 20
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.
Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 90
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.
Free Fraction of Free MPA at Day 4
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation
MPA Free fraction (in percent [%]) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.
Free Fraction of Free MPA at Day 8
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation
MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.
Free Fraction of Free MPA at Day 20
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation
MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.
Free Fraction of Free MPA at Day 90
Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation
MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.

6 secondary outcomes

Forced Expiratory Volume in 1 Second (FEV1) at Day 90 Post-Transplantation
Time frame: Day 90 post-transplantation
Percent of Predicted FEV1 at Day 90 Post-Transplantation
Time frame: Day 90 post-transplantation
Forced Vital Capacity (FVC) at Day 90 Post-Transplantation
Time frame: Day 90 post-transplantation
Change From Baseline in Intracellular Adenosine-Tri-Phosphate (iATP) Levels
Time frame: Baseline, Days 4, 8, 20 and 90 post-transplantation
Change From Baseline in T-Cell Phenotype
Time frame: Baseline, Days 20 and 90 post-transplantation
Percentage of Participants With Opportunistic Infections
Time frame: Up to Day 90

Results and safety

Results posted to the registry on 10 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MMF - Cystic Fibrosis	33	26
MMF - COPD, Emphysema, IPF, or A1AD	35	16

Primary outcome: Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4

Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 after transplantation. Mean (Standard Deviation). Unit: mg/L

Measure	MMF - Cystic Fibrosis n = 21	MMF - COPD, Emphysema, IPF, or A1AD n = 24
MPA	7.914 (5.46450)	5.608 (2.5591)
MPAG	117.210 (58.9632)	91.207 (26.3876)
AcMPAG	1.583 (0.9697)	1.810 (0.8306)

MMF - Cystic Fibrosis vs MMF - COPD, Emphysema, IPF, or A1AD: Hodges-Lehmann estimator: 1.305 (95% CI -0.8300 to 4.2500), p = 0.2649, Wilcoxon rank sum test
MMF - Cystic Fibrosis vs MMF - COPD, Emphysema, IPF, or A1AD: Hodges-Lehmann estimator: 11.405 (95% CI -10.2000 to 42.7800), p = 0.3113, Wilcoxon rank sum test
MMF - Cystic Fibrosis vs MMF - COPD, Emphysema, IPF, or A1AD: Hodges-Lehmann estimator: -0.305 (95% CI -0.8100 to 0.1900), p = 0.2953, Wilcoxon rank sum test

Population analysed: Per Protocol (PP) Population: Intent-to treat (ITT) population (received at least one dose of study drug and where the primary variable was measured at least once under study drug) excluding participants with major protocol violations (total 46 participants). Number of participants analyzed=participants who were evaluable for this outcome measure.

Primary outcome: Cmax of MPA, MPAG and AcMPAG at Day 8

Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation. Mean (Standard Deviation). Unit: mg/L

Measure	MMF - Cystic Fibrosis n = 20	MMF - COPD, Emphysema, IPF, or A1AD n = 22
MPA	5.124 (4.2748)	6.106 (3.3663)
MPAG	100.127 (54.0215)	100.128 (25.1228)
AcMPAG	1.007 (0.5914)	1.361 (0.9163)

MMF - Cystic Fibrosis vs MMF - COPD, Emphysema, IPF, or A1AD: Hodges-Lehmann estimator: -1.29 (95% CI -2.9900 to 0.4100), p = 0.1308, Wilcoxon rank sum test
MMF - Cystic Fibrosis vs MMF - COPD, Emphysema, IPF, or A1AD: Hodges-Lehmann estimator: -10.845 (95% CI -31.5000 to 20.7900), p = 0.4886, Wilcoxon rank sum test
MMF - Cystic Fibrosis vs MMF - COPD, Emphysema, IPF, or A1AD: Hodges-Lehmann estimator: -0.2 (95% CI -0.6000 to 0.1900), p = 0.2218, Wilcoxon rank sum test

Population analysed: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

Primary outcome: Cmax of MPA, MPAG and AcMPAG at Day 20

Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation. Mean (Standard Deviation). Unit: mg/L

Measure	MMF - Cystic Fibrosis n = 17	MMF - COPD, Emphysema, IPF, or A1AD n = 21
MPA	5.284 (3.8472)	6.762 (3.7405)
MPAG	93.882 (37.6112)	124.450 (45.0613)
AcMPAG	0.624 (0.3895)	1.434 (1.0501)

MMF - Cystic Fibrosis vs MMF - COPD, Emphysema, IPF, or A1AD: Hodges-Lehmann estimator: -1.87 (95% CI -3.7900 to 0.2800), p = 0.0886, Wilcoxon rank sum test
MMF - Cystic Fibrosis vs MMF - COPD, Emphysema, IPF, or A1AD: Hodges-Lehmann estimator: -30.76 (95% CI -54.9700 to -6.3600), p = 0.0220, Wilcoxon rank sum test
MMF - Cystic Fibrosis vs MMF - COPD, Emphysema, IPF, or A1AD: Hodges-Lehmann estimator: -0.56 (95% CI -1.0200 to -0.2700), p = 0.0008, Wilcoxon rank sum test

Population analysed: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

Primary outcome: Cmax of MPA, MPAG and AcMPAG at Day 90

Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation. Mean (Standard Deviation). Unit: mg/L

Measure	MMF - Cystic Fibrosis n = 15	MMF - COPD, Emphysema, IPF, or A1AD n = 12
MPA	12.915 (9.2479)	7.294 (3.1817)
MPAG	104.938 (44.6135)	113.453 (48.2935)
AcMPAG	1.375 (0.6514)	1.163 (0.6856)

MMF - Cystic Fibrosis vs MMF - COPD, Emphysema, IPF, or A1AD: Hodges-Lehmann estimator: 3.945 (95% CI 0.2500 to 8.2300), p = 0.0318, Wilcoxon rank sum test
MMF - Cystic Fibrosis vs MMF - COPD, Emphysema, IPF, or A1AD: Hodges-Lehmann estimator: -7.59 (95% CI -51.1900 to 30.7000), p = 0.7144, Wilcoxon rank sum test
MMF - Cystic Fibrosis vs MMF - COPD, Emphysema, IPF, or A1AD: Hodges-Lehmann estimator: 0.27 (95% CI -0.3100 to 0.8800), p = 0.3930, Wilcoxon rank sum test

Population analysed: PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline up to Day 90. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MMF - Cystic Fibrosis	13 of 33 (39.4%)	27 of 33 (81.8%)	Not reported
MMF - COPD, Emphysema, IPF, or A1AD	14 of 35 (40%)	29 of 35 (82.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mycophenolate mofetil in people with Lung Transplantation, run by Hoffmann-La Roche at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4 (time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 after transplantation). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01014442.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.