Trial Outcomes & Findings for Low Dose Thymoglobin in Renal Transplant Patients (NCT NCT01280617)
NCT ID: NCT01280617
Last Updated: 2021-03-16
Results Overview
Incidence of Biopsy Proven Acute Rejection at 1 year post transplant:
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
1 year from date of transplant
Results posted on
2021-03-16
Participant Flow
All unsensitized renal transplant recipients were considered eligible and were approached for consent. Inclusion dates were October 2010 until April 2013. A total of 58 patients were approached; 44 consented and were enrolled in the protocol
Participant milestones
| Measure |
Thymoglobulin 1.25mg/kg Dose
The safety and efficacy of low dose Thymoglobulin (1.25mg/kg) as an induction agent in renal transplant subjects.
Thymoglobulin: Thymoglobulin 1.25mg/kg dose
|
Thymoglobulin 0.75mg/kg Dose
The safety and efficacy of low dose Thymoglobulin (0.75mg/kg) as an induction agent in renal transplant subjects.
Thymoglobulin 0.75mg/kg dose: Thymoglobulin
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
|
Overall Study
COMPLETED
|
23
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Thymoglobulin 1.25mg/kg Dose
The safety and efficacy of low dose Thymoglobulin (1.25mg/kg) as an induction agent in renal transplant subjects.
Thymoglobulin: Thymoglobulin 1.25mg/kg dose
|
Thymoglobulin 0.75mg/kg Dose
The safety and efficacy of low dose Thymoglobulin (0.75mg/kg) as an induction agent in renal transplant subjects.
Thymoglobulin 0.75mg/kg dose: Thymoglobulin
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Low Dose Thymoglobin in Renal Transplant Patients
Baseline characteristics by cohort
| Measure |
Thymoglobulin 1.25mg/kg Dose
n=23 Participants
The safety and efficacy of low dose Thymoglobulin (1.25mg/kg) as an induction agent in renal transplant subjects.
Thymoglobulin: Thymoglobulin 1.25mg/kg dose
|
Thymoglobulin 0.75mg/kg Dose
n=20 Participants
The safety and efficacy of low dose Thymoglobulin (0.75mg/kg) as an induction agent in renal transplant subjects.
Thymoglobulin 0.75mg/kg dose: Thymoglobulin
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex/Gender, Customized
males
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Sex/Gender, Customized
females
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 year from date of transplantIncidence of Biopsy Proven Acute Rejection at 1 year post transplant:
Outcome measures
| Measure |
Thymoglobulin 1.25mg/kg Dose
n=23 Participants
Thymoglobulin 1.25mg/kg dose All Cause mortality 0/23
|
Thymoglobulin 0.75mg/kg Dose
n=20 Participants
Thymoglobulin 0.75mg/kg dose All Cause Mortality 3/20 - 2 with pre-existing cardiac disease, diabetes, and history of smoking
|
|---|---|---|
|
Rates of Acute Cellular Rejection Between Study Group
|
4 Number of rejection
|
2 Number of rejection
|
SECONDARY outcome
Timeframe: 1 year from date of transplantNumber of individual adverse events in high versus low dose Thymoglobulin groups will be tabulated and statistical analyses performed
Outcome measures
| Measure |
Thymoglobulin 1.25mg/kg Dose
n=23 Participants
Thymoglobulin 1.25mg/kg dose All Cause mortality 0/23
|
Thymoglobulin 0.75mg/kg Dose
n=20 Participants
Thymoglobulin 0.75mg/kg dose All Cause Mortality 3/20 - 2 with pre-existing cardiac disease, diabetes, and history of smoking
|
|---|---|---|
|
, "Total Number of Adverse Events, Including Any Infections, Leucopenia, and Malignancy"
|
3 Adverse Events
|
8 Adverse Events
|
Adverse Events
Thymoglobulin 1.25mg/kg Dose
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Thymoglobulin 0.75mg/kg Dose
Serious events: 2 serious events
Other events: 8 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Thymoglobulin 1.25mg/kg Dose
n=23 participants at risk
Thymoglobulin 1.25mg/kg dose All Cause mortality 0/23
|
Thymoglobulin 0.75mg/kg Dose
n=20 participants at risk
Thymoglobulin 0.75mg/kg dose All Cause Mortality 3/20 - 2 with pre-existing cardiac disease, diabetes, and history of smoking
|
|---|---|---|
|
Infections and infestations
Serious Infections
|
13.0%
3/23 • Number of events 3 • Day of kidney transplant until end of first post transplant year
|
10.0%
2/20 • Number of events 2 • Day of kidney transplant until end of first post transplant year
|
Other adverse events
| Measure |
Thymoglobulin 1.25mg/kg Dose
n=23 participants at risk
Thymoglobulin 1.25mg/kg dose All Cause mortality 0/23
|
Thymoglobulin 0.75mg/kg Dose
n=20 participants at risk
Thymoglobulin 0.75mg/kg dose All Cause Mortality 3/20 - 2 with pre-existing cardiac disease, diabetes, and history of smoking
|
|---|---|---|
|
Renal and urinary disorders
Delayed Graft Function
|
13.0%
3/23 • Number of events 3 • Day of kidney transplant until end of first post transplant year
|
40.0%
8/20 • Number of events 8 • Day of kidney transplant until end of first post transplant year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place