Trial Outcomes & Findings for Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients (NCT NCT00574197)

Last Updated: 2020-07-30

Results Overview

Side-effects using the GSRS (Gastrointestinal Symptoms Rating Scale) GSRS has 15 items, each rated on a 7-point scale from 1 (no discomfort) to 7 (very severe discomfort). GSRS total minimum value is 15; maximum value is 105. Higher scores represent greater discomfort.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2020-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	Enteric-coated Mycophenolate Sodium (Myfortic) 1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
Overall Study STARTED	11
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enteric-coated Mycophenolate Sodium (Myfortic) n=11 Participants 1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants
Region of Enrollment United States	11 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Outcome measures

Outcome measures
Measure	Enteric-coated Mycophenolate Sodium (Myfortic) n=6 Participants 1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
GI Tolerability as Measured by GSRS GSRS at 6 months	34.17 score on a scale Standard Deviation 19.47
GI Tolerability as Measured by GSRS GSRS at baseline	55.67 score on a scale Standard Deviation 15.49

SECONDARY outcome

Timeframe: 6 months

Number of biopsy proven acute rejection, graft loss, and death due to rejection. Number of rejection episodes where rejection is defined as Grade 1B or higher on myocardial biopsy as measured by the 1990 Grading System of the International Society of Heart and Lung Transplantation for Acute Cellular Rejection. Grading system has: * grade 0 (no acute rejection) * grade 1A (Focal, mild acute rejection) * grade 1B (Diffuse, mild acute rejection) * grade 2 (Focal, moderate acute rejection) * grade 3A (multifocal moderate rejection) * grade 3B (Diffuse, borderline severe acute rejection) * grade 4 (Severe acute rejection).

Outcome measures

Outcome measures
Measure	Enteric-coated Mycophenolate Sodium (Myfortic) n=20 myocardial biopsies 1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection. No rejection (Grade 0 or 1A)	20 myocardial biopsies
Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection. Rejection (Grade 1B or higher)	0 myocardial biopsies
Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection. Death due to rejection	0 myocardial biopsies

Adverse Events

Enteric-coated Mycophenolate Sodium (Myfortic)

Serious events: 8 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Enteric-coated Mycophenolate Sodium (Myfortic) n=11 participants at risk Enteric-coated Mycophenolate Sodium (Myfortic) 1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
Infections and infestations Sepsis	9.1% 1/11 • Number of events 1
Cardiac disorders Heart failure	9.1% 1/11 • Number of events 1
Cardiac disorders Heart re-transplant	9.1% 1/11 • Number of events 1
Gastrointestinal disorders Diarrhea	36.4% 4/11 • Number of events 4
Metabolism and nutrition disorders Failure to thrive	9.1% 1/11 • Number of events 1
Immune system disorders Anaphylactic reaction	9.1% 1/11 • Number of events 1
Blood and lymphatic system disorders Neutropenia	9.1% 1/11 • Number of events 1
Cardiac disorders Hypovolemia	9.1% 1/11 • Number of events 1
Musculoskeletal and connective tissue disorders Steroid induced myopathy	9.1% 1/11 • Number of events 1
Gastrointestinal disorders GI Bleeding	9.1% 1/11 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia	9.1% 1/11 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Ernst Schwarz, MD, PhD

Cedars-Sinai Medical Center

Phone: (310) 840-7089

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place