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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02091414

Enrollment

Registered

2014-03-19

Start date

2006-08-31

Completion date

2009-02-28

Last updated

2014-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplantation

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.

Interventions

DRUGmycophenolate mofetil (MMF)

1.0 g PO BID

DRUGcyclosporine 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

DRUGcorticosteroids

As per the practice of each participating center

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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 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 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
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

Countries

China

Participant flow

Participants by arm

Arm	Count
MMF + CsA Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.	36
Total	36

Arm

Count

MMF + CsA

Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	2
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	MMF + CsA
Age, Continuous	44.83 years STANDARD_DEVIATION 11.89
Sex: Female, Male Female	8 Participants
Sex: Female, Male Male	28 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	36 / 36
serious Total, serious adverse events	2 / 36

Outcome results

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.