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

Heart Transplantation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091414
• Other study ID #: ML20055
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2014
• Last updated: October 22, 2014
• Start date: August 2006
• Est. completion date: February 2009

Study information

• Verified date: October 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration of China (CFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of Participants With Graft Loss Within 24 Weeks of Transplantation		Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24	No
Secondary	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	No
Secondary	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	No
Secondary	Percentage of Participants Lost To Follow Up Within 24 Weeks of Transplantation		Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No