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

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.

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.

Study Overview

• Status: Completed
• Conditions: Heart Transplantation
• Intervention / Treatment: Drug: mycophenolate mofetil (MMF); Drug: cyclosporine A (CsA); Drug: corticosteroids

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
  • Fuzhou, China, 350001
  • Shanghai, China, 200032

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MMF, CsA, Corticosteroids; 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.

Drug: mycophenolate mofetil (MMF); 1.0 g PO BID; Other Names: CellCept; Drug: 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: corticosteroids; As per the practice of each participating center

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Graft Loss Within 24 Weeks of Transplantation	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	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	Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants Lost To Follow Up Within 24 Weeks of Transplantation	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	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	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	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	Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 19, 2014

Study Record Updates

• Last Update Posted (Estimate): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 22, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Antitubercular Agents; Antibiotics, Antitubercular; Calcineurin Inhibitors; Mycophenolic Acid; Cyclosporine; Cyclosporins
• Other Study ID Numbers: ML20055