Phase 3
Completed N=36
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.
Source: ClinicalTrials.gov NCT02091414 ↗Enrolled (actual)
36
Serious AEs
5.6%
Results posted
Oct 2014
Primary outcomePrimary: Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week — 0.0; 0.0; 2.78; 2.78 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week |
0.0; 0.0; 2.78; 2.78; 2.78; 2.78 | — |
| SECONDARY Percentage of Participants With Graft Loss Within 24 Weeks of Transplantation |
0.0 | — |
| SECONDARY Percentage of Participants Requiring Use of Additional Immunosuppressants Not Specified in the Protocol Within 24 Weeks of Transplantation |
0.0 | — |
| SECONDARY Percentage of Participants Discontinuing Immunosuppressants (MMF) for More Than 14 Consecutive Days or 30 Cumulative Days Within 24 Weeks of Transplantation |
13.89 | — |
| SECONDARY Percentage of Participants Lost To Follow Up Within 24 Weeks of Transplantation |
0.0 | — |
| SECONDARY Percentage of Participants With Normal Serum Creatinine and Blood Urea Nitrogen (BUN) Values At Baseline (BL) And During Treatment |
47.22; 8.33 | — |
| SECONDARY Percentage of Participants With Normal Serum Creatinine and BUN Values at Baseline and Abnormal Values During Treatment |
22.22; 16.67 | — |
| SECONDARY Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and Normal Values During Treatment |
16.67; 2.78 | — |
| SECONDARY Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and During Treatment |
13.89; 72.22 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02091414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.