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

Phase 3

Completed

• Conditions: Heart Transplantation
• Interventions: Drug: mycophenolate mofetil (MMF); Drug: cyclosporine A (CsA); Drug: corticosteroids

• Registration Number: NCT02091414
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-19
• Status Verified: 2014-10
• Results First Submitted: 2014-10-22
• Results First Submitted QC: 2014-10-22
• Last Update Submitted: 2014-10-22
• Results First Posted: 2014-10-29
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MMF, CsA, Corticosteroids	mycophenolate mofetil (MMF)	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.
MMF, CsA, Corticosteroids	cyclosporine A (CsA)	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.
MMF, CsA, Corticosteroids	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week	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.

Secondary Outcome Measures

Name	Time	Method
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
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 Graft Loss 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 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