Trial Outcomes & Findings for Inflammation in Chronic Kidney Disease and Cardiovascular Disease - The Role of Genetics and Interleukin-1 Receptor Antagonist (IL-1ra) (NCT NCT00897715)

NCT ID: NCT00897715

Last Updated: 2019-10-01

Results Overview

hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

baseline and 12 weeks

Results posted on

2019-10-01

Participant Flow

This study was conducted at the VA Nashville between 01/2013 and 02/2015. Note that essentially the same study was also conducted at the University of Colorado (NCT01663103). Results were combined with Colorado for publication. However, the results reported here are only based on the subjects enrolled at the VA Nashville.

There is about a 2-week screening period between enrollment and assignment to a treatment group to access inclusion/exclusion criteria. Although 45 subjects were enrolled, only 15 subjects were assigned to a treatment group (30 subjects were screen failures).

Participant milestones

Participant milestones
Measure	Interleukin-1 Receptor Antagonist active drug Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks	Placebo matching placebo Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks
Overall Study STARTED	8	7
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Interleukin-1 Receptor Antagonist active drug Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks	Placebo matching placebo Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	1	0
Overall Study increased risk of infection	1	0

Baseline Characteristics

Inflammation in Chronic Kidney Disease and Cardiovascular Disease - The Role of Genetics and Interleukin-1 Receptor Antagonist (IL-1ra)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interleukin-1 Receptor Antagonist n=8 Participants active drug Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks	Placebo n=7 Participants matching placebo Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks	Total n=15 Participants Total of all reporting groups
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	62 years STANDARD_DEVIATION 11.5 • n=5 Participants	67 years STANDARD_DEVIATION 6.2 • n=7 Participants	64 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: The number of participants for analysis was based on those subjects who completed the 12-week study, as well as 2 subjects who withdrew but completed end-of-study procedures (1 in each group). The analysis was per protocol. Note that the results reported here are only based on the subjects enrolled at the VA Nashville.

hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation

Outcome measures

Outcome measures
Measure	Interleukin-1 Receptor Antagonist n=7 Participants active drug Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks	Placebo n=7 Participants matching placebo Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks
Change in the Concentration of High Sensitivity C-Reactive Protein (hsCRP) From Baseline to 12 Weeks	-2.6 mg/dl Interval -3.05 to -1.35	0.8 mg/dl Interval -0.05 to 1.3

SECONDARY outcome

Timeframe: baseline and 12 weeks

IL-6 is a sensitive laboratory assay for serum levels of Interleukin-6, which is a pro-inflammatory cytokine that is used to evaluate the inflammatory response

Outcome measures

Outcome measures
Measure	Interleukin-1 Receptor Antagonist n=7 Participants active drug Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks	Placebo n=7 Participants matching placebo Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks
Change in Concentration of Interleukin-6 (IL-6) From Baseline to 12 Weeks	-0.63 pg/ml Interval -0.98 to 0.0	0.05 pg/ml Interval -0.18 to 0.53

Adverse Events

Interleukin-1 Receptor Antagonist

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Interleukin-1 Receptor Antagonist n=8 participants at risk active drug Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks	Placebo n=7 participants at risk matching placebo Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks
General disorders back pain	12.5% 1/8 • Number of events 2 • 12 weeks	0.00% 0/7 • 12 weeks
Skin and subcutaneous tissue disorders injection site reaction	12.5% 1/8 • Number of events 1 • 12 weeks	0.00% 0/7 • 12 weeks
Nervous system disorders nerve puncture	0.00% 0/8 • 12 weeks	14.3% 1/7 • Number of events 1 • 12 weeks
Infections and infestations infection	0.00% 0/8 • 12 weeks	14.3% 1/7 • Number of events 1 • 12 weeks
Cardiac disorders heart arrhythmia	0.00% 0/8 • 12 weeks	14.3% 1/7 • Number of events 1 • 12 weeks
General disorders burn	12.5% 1/8 • Number of events 1 • 12 weeks	0.00% 0/7 • 12 weeks
Gastrointestinal disorders cramps	12.5% 1/8 • Number of events 1 • 12 weeks	0.00% 0/7 • 12 weeks

Additional Information

Adriana Hung

VA Tennessee Valley Healthcare System.

Phone: 615-873-7480

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place