Trial Outcomes & Findings for Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant (NCT NCT00970073)
NCT ID: NCT00970073
Last Updated: 2018-10-09
Results Overview
Postoperative acute kidney injury is measured as reduced (eGFR) within 12 months post-surgery.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
12 Months
Results posted on
2018-10-09
Participant Flow
Participant milestones
| Measure |
Delayed CNI Group 1
Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)
Thymoglobulin 3mg total: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Delayed CNI Group 2
Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)
Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Early CNI / Control Arm
Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Delayed CNI Group 1
n=10 Participants
Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)
Thymoglobulin 3mg total: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Delayed CNI Group 2
n=10 Participants
Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)
Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Early CNI / Control Arm
n=10 Participants
Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
28 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
24 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
30 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPostoperative acute kidney injury is measured as reduced (eGFR) within 12 months post-surgery.
Outcome measures
| Measure |
Delayed CNI Group 1
n=10 Participants
Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)
Thymoglobulin 3mg total: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Delayed CNI Group 2
n=10 Participants
Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)
Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Early CNI / Control Arm
n=10 Participants
Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180.
|
|---|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery
|
72 mL/min
Interval 57.7 to 86.3
|
87.8 mL/min
Interval 67.3 to 108.3
|
51.0 mL/min
Interval 24.4 to 77.6
|
SECONDARY outcome
Timeframe: 12 months post-transplantPopulation: Kaplan- Meier
Outcome measures
| Measure |
Delayed CNI Group 1
n=10 Participants
Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)
Thymoglobulin 3mg total: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Delayed CNI Group 2
n=10 Participants
Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)
Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Early CNI / Control Arm
n=10 Participants
Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180.
|
|---|---|---|---|
|
Patient Survival
|
10 Participants
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 months post transplantPopulation: Kaplan Meier for patient survival
90% graft survival, related to the deaths of 3 patients during the study period.
Outcome measures
| Measure |
Delayed CNI Group 1
n=10 Participants
Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)
Thymoglobulin 3mg total: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Delayed CNI Group 2
n=10 Participants
Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)
Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Early CNI / Control Arm
n=10 Participants
Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180.
|
|---|---|---|---|
|
Graft Survival
|
10 Participants
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 30 daysAcute Allograft Rejection
Outcome measures
| Measure |
Delayed CNI Group 1
n=10 Participants
Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)
Thymoglobulin 3mg total: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Delayed CNI Group 2
n=10 Participants
Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)
Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Early CNI / Control Arm
n=10 Participants
Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180.
|
|---|---|---|---|
|
Allograft Rejection Rates at 30 Days
|
3 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Delayed CNI Group 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Delayed CNI Group 2
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Early CNI / Control Arm
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Delayed CNI Group 1
n=10 participants at risk
Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)
Thymoglobulin 3mg total: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Delayed CNI Group 2
n=10 participants at risk
Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)
Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Early CNI / Control Arm
n=10 participants at risk
Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Metastatic Lung Cancer
|
0.00%
0/10 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
|
Immune system disorders
Graft vs Host Disease
|
0.00%
0/10 • 1 Year
|
0.00%
0/10 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/10 • 1 Year
|
0.00%
0/10 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
Other adverse events
| Measure |
Delayed CNI Group 1
n=10 participants at risk
Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)
Thymoglobulin 3mg total: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Delayed CNI Group 2
n=10 participants at risk
Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)
Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
|
Early CNI / Control Arm
n=10 participants at risk
Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).
Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months
tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180.
|
|---|---|---|---|
|
Infections and infestations
HCV recurrence
|
20.0%
2/10 • Number of events 2 • 1 Year
|
50.0%
5/10 • Number of events 5 • 1 Year
|
40.0%
4/10 • Number of events 4 • 1 Year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place