Trial Outcomes & Findings for Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation (NCT NCT02417870)
NCT ID: NCT02417870
Last Updated: 2021-06-24
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
2 participants
Primary outcome timeframe
6 weeks
Results posted on
2021-06-24
Participant Flow
Participant milestones
| Measure |
Aldesleukin
aldesleukin
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation
Baseline characteristics by cohort
| Measure |
Aldesleukin
n=2 Participants
aldesleukin
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Study was termination prior to completion
Outcome measures
Outcome data not reported
Adverse Events
Aldesleukin
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aldesleukin
n=2 participants at risk
aldesleukin
|
|---|---|
|
Cardiac disorders
ischemic heart disease
|
50.0%
1/2 • Number of events 1 • 6 weeks
|
Other adverse events
| Measure |
Aldesleukin
n=2 participants at risk
aldesleukin
|
|---|---|
|
General disorders
Elevated Creatinine
|
100.0%
2/2 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place