Trial Outcomes & Findings for Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal (NCT NCT00374803)
NCT ID: NCT00374803
Last Updated: 2016-04-28
Results Overview
Treatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
12 months
Results posted on
2016-04-28
Participant Flow
Single center, 45 patients consecutively enrolled. Patients were randomized into two groups: (group 1) will be receive 2160 mg/day for two weeks, followed by 1440 mg/day thereafter, and (group 2) will receive 1440 mg/day for the duration of the study.
Participant milestones
| Measure |
Myfortic 1080mg BID, 720mg BID
Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
|
Myfortic 720 mg Twice Daily
Myfortic 720 mg twice daily (1440 mg/day).
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
|
Overall Study
COMPLETED
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
Baseline characteristics by cohort
| Measure |
Myfortic 1080mg BID, 720mg BID
n=22 Participants
Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
|
Myfortic 720 mg Twice Daily
n=23 Participants
Myfortic 720 mg twice daily (1440 mg/day).
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 14 • n=93 Participants
|
55 years
STANDARD_DEVIATION 13 • n=4 Participants
|
52 years
STANDARD_DEVIATION 14 • n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=93 Participants
|
23 participants
n=4 Participants
|
45 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsTreatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine
Outcome measures
| Measure |
Mycophenolic Acid Loading Group
n=22 Participants
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
|
Mycophenolic Acid No Load Group
n=23 Participants
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
|
|---|---|---|
|
Incidence of All Biopsy Proven Acute Rejection.
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPatient and allograft survival at 12 months post-transplant. Allograft survival is different from rejection. An allograft can have rejection, but the allograft can still have survival. If an allograft fails and is no longer functioning this would be considered allograft failure and non-survival.
Outcome measures
| Measure |
Mycophenolic Acid Loading Group
n=22 Participants
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
|
Mycophenolic Acid No Load Group
n=23 Participants
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
|
|---|---|---|
|
Patient and Allograft Survival 12 Months
Patient Survival
|
22 participants
|
23 participants
|
|
Patient and Allograft Survival 12 Months
Allograft Survival
|
22 participants
|
22 participants
|
SECONDARY outcome
Timeframe: 12 monthsRenal function measured by serum creatinine (SCr) at 12 months post-transplant
Outcome measures
| Measure |
Mycophenolic Acid Loading Group
n=22 Participants
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
|
Mycophenolic Acid No Load Group
n=22 Participants
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
|
|---|---|---|
|
Renal Function at 12 Months
|
1.36 mg/dL
Standard Deviation 0.4
|
1.5 mg/dL
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 12 monthsIncidence of post transplant infections that resulted in hospitalization
Outcome measures
| Measure |
Mycophenolic Acid Loading Group
n=22 Participants
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
|
Mycophenolic Acid No Load Group
n=23 Participants
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
|
|---|---|---|
|
Incidence of Post Transplant Infections
|
4 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 12 monthsHospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic)
Outcome measures
| Measure |
Mycophenolic Acid Loading Group
n=22 Participants
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
|
Mycophenolic Acid No Load Group
n=23 Participants
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
|
|---|---|---|
|
GI Toxicities
|
5 participants
|
4 participants
|
Adverse Events
Mycophenolic Acid Loading Group
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Mycophenolic Acid No Load Group
Serious events: 14 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mycophenolic Acid Loading Group
n=22 participants at risk
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
|
Mycophenolic Acid No Load Group
n=23 participants at risk
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/22 • 12 months
|
4.3%
1/23 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
0.00%
0/22 • 12 months
|
4.3%
1/23 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
9.1%
2/22 • Number of events 4 • 12 months
|
17.4%
4/23 • Number of events 4 • 12 months
|
|
General disorders
Fever
|
4.5%
1/22 • Number of events 1 • 12 months
|
4.3%
1/23 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/22 • 12 months
|
8.7%
2/23 • Number of events 2 • 12 months
|
|
Investigations
Creatinine Increased
|
0.00%
0/22 • 12 months
|
17.4%
4/23 • Number of events 8 • 12 months
|
|
Renal and urinary disorders
Acute Tubular Necrosis
|
0.00%
0/22 • 12 months
|
4.3%
1/23 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Acute Kidney Failure
|
4.5%
1/22 • Number of events 1 • 12 months
|
0.00%
0/23 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/22 • 12 months
|
4.3%
1/23 • Number of events 1 • 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/22 • 12 months
|
8.7%
2/23 • Number of events 2 • 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/22 • 12 months
|
4.3%
1/23 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
4.5%
1/22 • Number of events 1 • 12 months
|
4.3%
1/23 • Number of events 1 • 12 months
|
|
Vascular disorders
Worsening Hypertension
|
4.5%
1/22 • Number of events 1 • 12 months
|
0.00%
0/23 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/22 • 12 months
|
4.3%
1/23 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.00%
0/22 • 12 months
|
4.3%
1/23 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Dehiscence with evisceration
|
0.00%
0/22 • 12 months
|
4.3%
1/23 • Number of events 2 • 12 months
|
|
Cardiac disorders
Coronary Artery Bypass
|
0.00%
0/22 • 12 months
|
4.3%
1/23 • Number of events 1 • 12 months
|
|
Infections and infestations
Wound Infection
|
0.00%
0/22 • 12 months
|
4.3%
1/23 • Number of events 1 • 12 months
|
|
Nervous system disorders
Altered Mental Status
|
0.00%
0/22 • 12 months
|
4.3%
1/23 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post-transplant lymphoproliferative disorder (PTLD)
|
0.00%
0/22 • 12 months
|
4.3%
1/23 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Mycophenolic Acid Loading Group
n=22 participants at risk
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
|
Mycophenolic Acid No Load Group
n=23 participants at risk
Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
4/22 • 12 months
|
17.4%
4/23 • 12 months
|
|
Skin and subcutaneous tissue disorders
Wound dehiscence
|
9.1%
2/22 • 12 months
|
0.00%
0/23 • 12 months
|
|
Immune system disorders
CMV Viremia
|
9.1%
2/22 • 12 months
|
4.3%
1/23 • 12 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
40.9%
9/22 • 12 months
|
45.5%
10/22 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place