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Completed

NCT Number: NCT02091414

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

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Key information

Conditions

Heart Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mycophenolate Mofetil (MMF)

Drug

1.0 g PO BID

Other names: CellCept

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

Corticosteroids

Drug

As per the practice of each participating center

Primary outcomes

  1. Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week

    Time frame: 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 outcomes

  1. Percentage of Participants With Graft Loss Within 24 Weeks of Transplantation

    Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24

  2. Percentage of Participants Requiring Use of Additional Immunosuppressants Not Specified in the Protocol Within 24 Weeks of Transplantation

    Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24

  3. Percentage of Participants Discontinuing Immunosuppressants (MMF) for More Than 14 Consecutive Days or 30 Cumulative Days Within 24 Weeks of Transplantation

    Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24

  4. Percentage of Participants Lost To Follow Up Within 24 Weeks of Transplantation

    Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24

  5. Percentage of Participants With Normal Serum Creatinine and Blood Urea Nitrogen (BUN) Values At Baseline (BL) And During Treatment

    Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24

  6. Percentage of Participants With Normal Serum Creatinine and BUN Values at Baseline and Abnormal Values During Treatment

    Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24

  7. Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and Normal Values During Treatment

    Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24

  8. Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and During Treatment

    Time frame: Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Mar 19, 2014
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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