Heart TransplantationPhase 3NCT02091414

A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.

A Phase 3 study testing mycophenolate mofetil (MMF), cyclosporine A (CsA) and corticosteroids in people with Heart Transplantation, run by Hoffmann-La Roche at 3 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

This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and steroids, in patients receiving a heart transplant. The anticipated time on study treatment is 24 weeks. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Transplantation
What is being tested?: mycophenolate mofetil (MMF), cyclosporine A (CsA) and corticosteroids
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 3 sitesChina
Study dates: Aug 2006to Feb 2009
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

adult patients, >=18 years of age;
patients receiving their first heart transplant (single organ transplant).

Who cannot join

patients with a positive donor-specific cross-match at the time of transplantation;
patients with any antibody-treated acute rejection;
known contraindications to treatment with sirolimus;
history of malignancy, other than excised non-melanoma skin cancer which has not recurred for 2 years.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Study site
Beijing, 100029
Study site
Fuzhou, 350001
Study site
Shanghai, 200032

Other trials in China

About this study

Official title: An Open Label Study to Evaluate the Effect of CellCept in Combination With Cyclosporine A and Steroids on Renal Function and the Prevention of Acute Rejection in Heart Transplant Patients.

Conditions: Heart Transplantation
Being tested: mycophenolate mofetil (MMF), cyclosporine A (CsA), corticosteroids

What participants receive

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

mycophenolate mofetil (MMF)Drug
Also called CellCept
1.0 g PO BID
cyclosporine A (CsA)Drug
Initial loading dose of 4 to 6 mg/kg within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 ng/mL
corticosteroidsDrug
As per the practice of each participating center

Study groups in NCT02091414
Study group	Role	What they receive
MMF, CsA, Corticosteroids	Experimental	Participants received mycophenolate mofetil (MMF) 1.0 grams (g), orally (PO), twice daily (BID) from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of cyclosporine A (CsA) 4 to 6 milligrams per kilogram (mg/kg) within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 nanograms per milliliter (ng/mL) through Week 24. Participants also received corticosteroids as per the practice of each participating center. Receives: Drug: mycophenolate mofetil (MMF); Drug: cyclosporine A (CsA); Drug: corticosteroids

What is being measured

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

Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week
Percentage of participants with BPAR of greater than or equal to (≥) International Society of Heart and Lung Transplant (ISHLT) Grade III. The ISHLT graded symptoms on a scale of Grade 0 through VI. Grade 0 equals (=) no rejection. Grade IA = regional (perivascular or interstitial) infiltration and no necrosis, and grade IB = dissemination but little infiltration and no necrosis. Grade II = 1 focus of invasive infiltration with or without (+/-) associated cardiomyocyte necrosis. Grade IIIA = 2 or more foci of invasive infiltration +/- associated cardiomyocyte necrosis, and grade IIIB = diffuse inflammatory pathological changes associated with cardiomyocyte necrosis. Grade IV = diffuse, infiltrative multi-foci +/- edema; +/- hemorrhage; and +/-vasculitis.
Measured: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24

Secondary outcomes (8)

Percentage of Participants With Graft Loss Within 24 Weeks of Transplantation
Measured: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants Requiring Use of Additional Immunosuppressants Not Specified in the Protocol Within 24 Weeks of Transplantation
Measured: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants Discontinuing Immunosuppressants (MMF) for More Than 14 Consecutive Days or 30 Cumulative Days Within 24 Weeks of Transplantation
Measured: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants Lost To Follow Up Within 24 Weeks of Transplantation
Measured: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With Normal Serum Creatinine and Blood Urea Nitrogen (BUN) Values At Baseline (BL) And During Treatment
Measured: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With Normal Serum Creatinine and BUN Values at Baseline and Abnormal Values During Treatment
Measured: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and Normal Values During Treatment
Measured: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and During Treatment
Measured: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24

Timeline

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

Aug 2006Feb 2009

First posted19 Mar 2014 (estimated)
Study startAug 2006
Primary completionFeb 2009
Study completionFeb 2009

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 Heart 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: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02091414
Sponsor's protocol ID: ML20055
Status last verified: Oct 2014
First submitted: 5 Mar 2014
Last updated: 29 Oct 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

Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
RecruitingPhase 3
SWITCH: Apixaban vs Vitamin K in HM3
LVAD (Left Ventricular Assist Device) Thrombosis, Heart Failure
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship

All Heart Transplantation trials

Study at a glance

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

Official title: An Open Label Study to Evaluate the Effect of CellCept in Combination With Cyclosporine A and Steroids on Renal Function and the Prevention of Acute Rejection in Heart Transplant Patients.
ClinicalTrials.gov ID: NCT02091414
Acronym / sponsor ID: ML20055
Conditions: Heart Transplantation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Aug 2006
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 19 Mar 2014 (estimated)
Results: Posted 29 Oct 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MMF, CsA, Corticosteroids	Experimental	Drug: mycophenolate mofetil (MMF), Drug: cyclosporine A (CsA), Drug: corticosteroidsParticipants received mycophenolate mofetil (MMF) 1.0 grams (g), orally (PO), twice daily (BID) from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of cyclosporine A (CsA) 4 to 6 milligrams per kilogram (mg/kg) within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 nanograms per milliliter (ng/mL) through Week 24. Participants also received corticosteroids as per the practice of each participating center.

Who may qualify

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

Key inclusion criteria (2 listed)

adult patients, >=18 years of age;
patients receiving their first heart transplant (single organ transplant).

Key exclusion criteria (4 listed)

patients with a positive donor-specific cross-match at the time of transplantation;
patients with any antibody-treated acute rejection;
known contraindications to treatment with sirolimus;
history of malignancy, other than excised non-melanoma skin cancer which has not recurred for 2 years.

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 mofetil (MMF)Also: CellCept1.0 g PO BID	Drug	MMF, CsA, Corticosteroids
cyclosporine A (CsA)Initial loading dose of 4 to 6 mg/kg within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 ng/mL	Drug	MMF, CsA, Corticosteroids
corticosteroidsAs per the practice of each participating center	Drug	MMF, CsA, Corticosteroids

Primary outcome

Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week
Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of participants with BPAR of greater than or equal to (≥) International Society of Heart and Lung Transplant (ISHLT) Grade III. The ISHLT graded symptoms on a scale of Grade 0 through VI. Grade 0 equals (=) no rejection. Grade IA = regional (perivascular or interstitial) infiltration and no necrosis, and grade IB = dissemination but little infiltration and no necrosis. Grade II = 1 focus of invasive infiltration with or without (+/-) associated cardiomyocyte necrosis. Grade IIIA = 2 or more foci of invasive infiltration +/- associated cardiomyocyte necrosis, and grade IIIB = diffuse inflammatory pathological changes associated with cardiomyocyte necrosis. Grade IV = diffuse, infiltrative multi-foci +/- edema; +/- hemorrhage; and +/-vasculitis.

8 secondary outcomes

Percentage of Participants With Graft Loss Within 24 Weeks of Transplantation
Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants Requiring Use of Additional Immunosuppressants Not Specified in the Protocol Within 24 Weeks of Transplantation
Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants Discontinuing Immunosuppressants (MMF) for More Than 14 Consecutive Days or 30 Cumulative Days Within 24 Weeks of Transplantation
Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants Lost To Follow Up Within 24 Weeks of Transplantation
Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With Normal Serum Creatinine and Blood Urea Nitrogen (BUN) Values At Baseline (BL) And During Treatment
Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With Normal Serum Creatinine and BUN Values at Baseline and Abnormal Values During Treatment
Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and Normal Values During Treatment
Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and During Treatment
Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24

Results and safety

Results posted to the registry on 29 Oct 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) Plus (+) Cyclosporine A (CsA)	36	32

Primary outcome: Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week

Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24. Number (95% Confidence Interval). Unit: percentage of participants

Measure	MMF + CsA n = 36
Day 1	0.0 (0.00 to 0.00)
Week 1	0.0 (0.00 to 0.00)
Week 2	2.78 (0.00 to 8.42)
Week 4	2.78 (0.00 to 8.42)
Week 8	2.78 (0.00 to 8.42)
Week 12	2.78 (0.00 to 8.42)
Week 16	2.78 (0.00 to 8.42)
Week 20	2.78 (0.00 to 8.42)

Population analysed: ITT population

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed at Day 1, and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MMF + CsA	2 of 36 (5.6%)	36 of 36 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

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

Related trials for Heart Transplantation

Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
RecruitingPhase 3
SWITCH: Apixaban vs Vitamin K in HM3
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RecruitingObservational study
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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 chair

Hoffmann-La Roche

3 sites 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 (MMF), cyclosporine A (CsA) and corticosteroids in people with Heart Transplantation, run by Hoffmann-La Roche at 3 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 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 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 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 29 Oct 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 Biopsy Proven Acute Rejection (BPAR) by Week (time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24). 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 NCT02091414.

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 Oct 2014.