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

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

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 weeks

Population: 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

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

Other adverse events
Measure
Aldesleukin
n=2 participants at risk
aldesleukin
General disorders
Elevated Creatinine
100.0%
2/2 • 6 weeks

Additional Information

Anil Chandraker

Brigham and Women's Hospital

Phone: 617-732-7412

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place