Liver TransplantationPhase 4NCT00717314

A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.

A Phase 4 study testing Mycophenolate mofetil, CNI (50%) and CNI (≥75%) in people with Liver Transplantation, run by Hoffmann-La Roche at 11 sites in China.

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: Liver Transplantation
What is being tested?: Mycophenolate mofetil, CNI (50%) and CNI (≥75%)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 11 sitesChina
Study dates: May 2008to Jul 2011
Phase: Phase 4
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

adult patients, >=18 years of age;
single organ recipients of liver allograft;
CNI-based immunosuppressive regimen prior to study entry and regimen adjustment;
>=6 months post-transplant, with renal dysfunction (serum creatinine 140-300micromol/L at entry);
negative pregnancy test for women of childbearing potential; contraception must be taken before beginning study drug therapy and until 6 weeks after last dose of study medication.

Who cannot join

treatment with CellCept or any other product which delivers mycophenolic acid within the 3 months prior to the recent switch to CellCept relevant for enrollment;
known contraindications to CNI, corticosteroids or CellCept.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

China11 sites

Study site
Beijing, 100039
Study site
Beijing, 100054
Study site
Changsha, 410013
Study site
Chengdu, 610041
Study site
Chongqing, 400038
Study site
Guangzhou, 510080
Study site
Jiangsu, 210029
Study site
Shanghai, 200003
Study site
Shanghai, 200080
Study site
Tianjin, 300192
Study site
Xi'an, 710032

Other trials in China

About this study

Official title: A Randomized, Open Label Study Comparing the Effect of CellCept Combined With 2 Regimens of Reduced Calcineurin Inhibitors on Kidney Function in Liver Transplant Patients

This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants. Patients currently receiving CNI treatment will be randomized into one of 2 groups to receive either 1) CellCept 2.0g/day po bid + 50% reduction of CNI from baseline or 2) CellCept 2.0g/day po bid + >=75% reduction of CNI from baseline. The anticipated time on study treatment is 1 year, and the target sample size is <100 individuals.

Conditions: Liver Transplantation
Being tested: Mycophenolate mofetil, CNI (50%), CNI (≥75%)

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 to 2.0 g daily PO BID
CNI (50%)Drug
50% reduction from BL
CNI (≥75%)Drug
≥75% reduction from BL

Study groups in NCT00717314
Study group	Role	What they receive
MMF, 50% CNI Reduction	Experimental	Participants received mycophenolate mofetil (MMF), 1.5 to 2.0 grams (g) daily, orally (PO), twice per day (BID) from baseline (BL) to Week 52. Participants also received a 50 percent (%) reduced dose of calcineurin inhibitor (CNI) from BL to Week 52. Receives: Drug: Mycophenolate mofetil; Drug: CNI (50%)
MMF, ≥75% CNI Reduction	Experimental	Participants received MMF, 1.5 to 2.0 g daily, PO, BID from BL to Week 52. Participants also received a 75% reduced dose of CNI from BL to Week 52. Receives: Drug: Mycophenolate mofetil; Drug: CNI (≥75%)

What is being measured

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

Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20%
The percentage of participants with a greater than 20% decrease of GFR during the 1-year period following regimen adjustment. Cockcroft and Gault formula was used for calculated creatinine clearance.
Measured: Week 52

Secondary outcomes (6)

Percentage of Participants With Graft Loss or Death at Week 52
Graft loss was defined for this protocol as re-transplantion or death.
Measured: Week 52
Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52
BPAR was graded according to Banff criteria.
Measured: Week 52
Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min])
Creatinine clearance calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min equaled (=) [(140 minus (-) age in years) multiplied by (*) (weight in kilograms (kg)] divided by [72 * serum creatinine in milligrams per deciliter (mg/dL)]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL).
Measured: Baseline and Weeks 16, 28, and 40
Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52
Corrected creatinine clearance was calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min = [(140 - age in years) * (weight in kg] divided by [72 * serum creatinine in mg/dL]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL).
Measured: Week 52
Percentage Change in Creatinine Clearance From Baseline
Creatinine clearance was calculated using the Cockcroft and Gault formula.
Measured: Weeks 16, 28, 40, and 52
Percentage of Participants Experiencing Acute Rejection, Graft Loss, Death, or a Decrease From BL in Creatinine Clearance of ≥20% at Week 52
The percentage of participants who experienced at least 1 of the following: a ≥20% decrease from BL in creatinine clearance, acute rejection, graft loss, or death 1 year after randomization.
Measured: Week 52

Timeline

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

May 2008Jul 2011

First posted17 Jul 2008 (estimated)
Study startMay 2008
Primary completionJul 2011
Study completionJul 2011

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 Liver 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00717314
Sponsor's protocol ID: ML21241
Status last verified: Sep 2014
First submitted: 16 Jul 2008
Last updated: 29 Sep 2014
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?

See locations

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All Liver Transplantation trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label Study Comparing the Effect of CellCept Combined With 2 Regimens of Reduced Calcineurin Inhibitors on Kidney Function in Liver Transplant Patients
ClinicalTrials.gov ID: NCT00717314
Acronym / sponsor ID: ML21241
Conditions: Liver Transplantation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 17 Jul 2008 (estimated)
Results: Posted 29 Sep 2014

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MMF, 50% CNI Reduction	Experimental	Drug: Mycophenolate mofetil, Drug: CNI (50%)Participants received mycophenolate mofetil (MMF), 1.5 to 2.0 grams (g) daily, orally (PO), twice per day (BID) from baseline (BL) to Week 52. Participants also received a 50 percent (%) reduced dose of calcineurin inhibitor (CNI) from BL to Week 52.
MMF, ≥75% CNI Reduction	Experimental	Drug: Mycophenolate mofetil, Drug: CNI (≥75%)Participants received MMF, 1.5 to 2.0 g daily, PO, BID from BL to Week 52. Participants also received a 75% reduced dose of CNI from BL to Week 52.

Who may qualify

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

Key inclusion criteria (5 listed)

adult patients, >=18 years of age;
single organ recipients of liver allograft;
CNI-based immunosuppressive regimen prior to study entry and regimen adjustment;
>=6 months post-transplant, with renal dysfunction (serum creatinine 140-300micromol/L at entry);
negative pregnancy test for women of childbearing potential; contraception must be taken before beginning study drug therapy and until 6 weeks after last dose of study medication.

Key exclusion criteria (2 listed)

treatment with CellCept or any other product which delivers mycophenolic acid within the 3 months prior to the recent switch to CellCept relevant for enrollment;
known contraindications to CNI, corticosteroids or CellCept.

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 to 2.0 g daily PO BID	Drug	MMF, 50% CNI Reduction, MMF, ≥75% CNI Reduction
CNI (50%)50% reduction from BL	Drug	MMF, 50% CNI Reduction
CNI (≥75%)≥75% reduction from BL	Drug	MMF, ≥75% CNI Reduction

Primary outcome

Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20%
Time frame: Week 52
The percentage of participants with a greater than 20% decrease of GFR during the 1-year period following regimen adjustment. Cockcroft and Gault formula was used for calculated creatinine clearance.

6 secondary outcomes

Percentage of Participants With Graft Loss or Death at Week 52
Time frame: Week 52
Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52
Time frame: Week 52
Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min])
Time frame: Baseline and Weeks 16, 28, and 40
Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52
Time frame: Week 52
Percentage Change in Creatinine Clearance From Baseline
Time frame: Weeks 16, 28, 40, and 52
Percentage of Participants Experiencing Acute Rejection, Graft Loss, Death, or a Decrease From BL in Creatinine Clearance of ≥20% at Week 52
Time frame: Week 52

Results and safety

Results posted to the registry on 29 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mycophenolate Mofetil (MMF), 50% Calcineurin Inhibitor (CNI)	43	37
MMF, 75% CNI	44	34

Primary outcome: Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20%

Time frame: Week 52. Number. Unit: percentage of participants

Measure	MMF, 50% CNI n = 37	MMF, 75% CNI n = 34
Value	5.4	0.0

MMF, 50% CNI vs MMF, 75% CNI: p = 0.494, ANOVA

Population analysed: PP population

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MMF, 50% CNI	1 of 43 (2.3%)	15 of 43 (34.9%)	Not reported
MMF, 75% CNI	3 of 40 (7.5%)	15 of 40 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Liver Transplantation

Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
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New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mycophenolate mofetil, CNI (50%) and CNI (≥75%) in people with Liver Transplantation, run by Hoffmann-La Roche at 11 sites in China.

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 5 inclusion and 2 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 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 29 Sep 2014). 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?

Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20% (time frame: Week 52). 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 NCT00717314.

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 29 Sep 2014.