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

Roche

Status and phase: Completed; Phase 3

Conditions: Heart Transplantation

Treatments: Drug: corticosteroids; Drug: mycophenolate mofetil (MMF); Drug: cyclosporine A (CsA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02091414

ML20055

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

36 participants in 1 patient group

MMF, CsA, Corticosteroids

Experimental group

Description:

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.

Treatment:

Drug: cyclosporine A (CsA)

Drug: mycophenolate mofetil (MMF)

Drug: corticosteroids