Clinical trial NCT02091414: A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-03-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week
timeFrame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Secondary outcomes:
measure: Percentage of Participants With Graft Loss Within 24 Weeks of Transplantation
timeFrame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Requiring Use of Additional Immunosuppressants Not Specified in the Protocol Within 24 Weeks of Transplantation
timeFrame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Discontinuing Immunosuppressants (MMF) for More Than 14 Consecutive Days or 30 Cumulative Days Within 24 Weeks of Transplantation
timeFrame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Lost To Follow Up Within 24 Weeks of Transplantation
timeFrame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With Normal Serum Creatinine and Blood Urea Nitrogen (BUN) Values At Baseline (BL) And During Treatment
timeFrame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With Normal Serum Creatinine and BUN Values at Baseline and Abnormal Values During Treatment
timeFrame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and Normal Values During Treatment
timeFrame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and During Treatment
timeFrame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Other outcomes:
Locations:
city: Beijing
country: China
city: Fuzhou
country: China
city: Shanghai
country: China
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: