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

NCT02091414 | Completed Phase 3 Results

• 1 other identifier: ML20055
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Heart Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (1)

MMF, CsA, Corticosteroids

EXPERIMENTAL

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); Drug: cyclosporine A (CsA); Drug: corticosteroids

Interventions

mycophenolate mofetil (MMF) DRUG

1.0 g PO BID

Also known as: CellCept

MMF, CsA, Corticosteroids

cyclosporine A (CsA) DRUG

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

MMF, CsA, Corticosteroids

corticosteroids DRUG

As per the practice of each participating center

MMF, CsA, Corticosteroids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Unknown Facility

Beijing, 100029, China

Location

Unknown Facility

Fuzhou, 350001, China

Location

Unknown Facility

Shanghai, 200032, China

Location

MeSH Terms

Interventions

Mycophenolic Acid; Cyclosporine; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 19, 2014
• Study Start: August 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: October 29, 2014
• Results First Posted: October 29, 2014

Record last verified: 2014-10

Locations

CN (3)