Trial · NCT01014442

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

NCT01014442, Phase 3, Completed, Hoffmann-La Roche; results first posted 2017-02-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Mycophenolate Mofetil (CellCept) in Lung Transplant Recipients. Trials, record NCT01014442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01014442

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Mycophenolate Mofetil (CellCept) in Lung Transplant Recipients
NCT number: NCT01014442
Status: Completed
Phases: Phase 3
Enrollment: 68 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Lung Transplantation
Interventions: mycophenolate mofetil
First posted: 2009-11-17
Last updated: 2017-02-10
Results first posted: 2017-02-10

Source ClinicalTrials.gov

Registered outcomes54

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4	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).
Primary	Cmax of MPA, MPAG and AcMPAG at Day 8	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.
Primary	Cmax of MPA, MPAG and AcMPAG at Day 20	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.
Primary	Cmax of MPA, MPAG and AcMPAG at Day 90	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.
Primary	Cmax of Free MPA at Day 4	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).
Primary	Cmax of Free MPA at Day 8	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.
Primary	Cmax of Free MPA at Day 20	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.
Primary	Cmax of Free MPA at Day 90	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.
Primary	Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4	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.
Primary	Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8	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.

1 to 10 of 54Source ClinicalTrials.gov

See all 54 registered outcomes

Outcomes54

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4	Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 after transplantation	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.	mg/L	MEAN
PRIMARY	Cmax of MPA, MPAG and AcMPAG at Day 8	Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation	PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.	mg/L	MEAN
PRIMARY	Cmax of MPA, MPAG and AcMPAG at Day 20	Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation	PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.	mg/L	MEAN
PRIMARY	Cmax of MPA, MPAG and AcMPAG at Day 90	Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation	PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.	mg/L	MEAN
PRIMARY	Cmax of Free MPA at Day 4	Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation	PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.	mcg/L	MEAN
PRIMARY	Cmax of Free MPA at Day 8	Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation	PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.	mcg/L	MEAN
PRIMARY	Cmax of Free MPA at Day 20	Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation	PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.	mcg/L	MEAN
PRIMARY	Cmax of Free MPA at Day 90	Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation	PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.	mcg/L	MEAN
PRIMARY	Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4	Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation	PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.	1/L	MEAN
PRIMARY	Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8	Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation	PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.	1/L	MEAN

1 to 10 of 54Source ClinicalTrials.gov

See all 54 outcomes

Results by group304

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4	MMF - Cystic Fibrosis	MPA	7.914	Standard Deviation 5.46450	mg/L
Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4	MMF - COPD, Emphysema, IPF, or A1AD	MPA	5.608	Standard Deviation 2.5591	mg/L
Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4	MMF - Cystic Fibrosis	MPAG	117.210	Standard Deviation 58.9632	mg/L
Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4	MMF - COPD, Emphysema, IPF, or A1AD	MPAG	91.207	Standard Deviation 26.3876	mg/L
Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4	MMF - Cystic Fibrosis	AcMPAG	1.583	Standard Deviation 0.9697	mg/L
Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4	MMF - COPD, Emphysema, IPF, or A1AD	AcMPAG	1.810	Standard Deviation 0.8306	mg/L
Cmax of MPA, MPAG and AcMPAG at Day 8	MMF - Cystic Fibrosis	MPA	5.124	Standard Deviation 4.2748	mg/L
Cmax of MPA, MPAG and AcMPAG at Day 8	MMF - COPD, Emphysema, IPF, or A1AD	MPA	6.106	Standard Deviation 3.3663	mg/L
Cmax of MPA, MPAG and AcMPAG at Day 8	MMF - Cystic Fibrosis	MPAG	100.127	Standard Deviation 54.0215	mg/L
Cmax of MPA, MPAG and AcMPAG at Day 8	MMF - COPD, Emphysema, IPF, or A1AD	MPAG	100.128	Standard Deviation 25.1228	mg/L

1 to 10 of 304Source ClinicalTrials.gov

See all 304 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	MMF - Cystic Fibrosis	33
Overall Study	STARTED	MMF - COPD, Emphysema, IPF, or A1AD	35
Overall Study	COMPLETED	MMF - Cystic Fibrosis	26
Overall Study	COMPLETED	MMF - COPD, Emphysema, IPF, or A1AD	16
Overall Study	NOT COMPLETED	MMF - Cystic Fibrosis	7
Overall Study	NOT COMPLETED	MMF - COPD, Emphysema, IPF, or A1AD	19

Source ClinicalTrials.gov

Adverse events142

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	MMF - Cystic Fibrosis	3	33
other	Anaemia	Blood and lymphatic system disorders	MMF - COPD, Emphysema, IPF, or A1AD	8	35
other	Hyperchromic anaemia	Blood and lymphatic system disorders	MMF - Cystic Fibrosis	3	33
other	Hyperchromic anaemia	Blood and lymphatic system disorders	MMF - COPD, Emphysema, IPF, or A1AD	0	35
other	Leukopenia	Blood and lymphatic system disorders	MMF - Cystic Fibrosis	8	33
other	Leukopenia	Blood and lymphatic system disorders	MMF - COPD, Emphysema, IPF, or A1AD	3	35
other	Normochromic normocytic anaemia	Blood and lymphatic system disorders	MMF - Cystic Fibrosis	1	33
other	Normochromic normocytic anaemia	Blood and lymphatic system disorders	MMF - COPD, Emphysema, IPF, or A1AD	2	35
other	Thrombocytopenia	Blood and lymphatic system disorders	MMF - Cystic Fibrosis	2	33
other	Thrombocytopenia	Blood and lymphatic system disorders	MMF - COPD, Emphysema, IPF, or A1AD	1	35

1 to 10 of 142Source ClinicalTrials.gov

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Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MMF - Cystic Fibrosis
Total, all-cause mortality	MMF - COPD, Emphysema, IPF, or A1AD
Total, other adverse events	MMF - Cystic Fibrosis	27	33
Total, other adverse events	MMF - COPD, Emphysema, IPF, or A1AD	29	35
Total, serious adverse events	MMF - Cystic Fibrosis	13	33
Total, serious adverse events	MMF - COPD, Emphysema, IPF, or A1AD	14	35

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
MMF - Cystic Fibrosis vs MMF - COPD, Emphysema, IPF, or A1AD: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01014442

GET https://conductscience.org/api/trials/v1/NCT01014442/registered?page=2

API reference For AI assistants