Trial Outcomes & Findings for Inflammation, Proteolysis and IL-1 Beta Receptor Inhibition in Chronic Hemodialysis Patients (NCT NCT00420290)

NCT ID: NCT00420290

Last Updated: 2011-11-17

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: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: month 1
• Results posted on: 2011-11-17

Participant Flow

This study was conducted at the Vanderbilt University Medical Center and Nashville Veterans Affairs Outpatient Dialysis units between January 2008 and May 2010.

There is a 3-month screening period following enrollment to determine level of inflammation. To be eligible to participate in the intervention phase of the study and be assigned to a group, participants must have three consecutive CRP levels > 5 mg/L. Although 31 subjects were enrolled, only 22 were eligible to be assigned to a group.

Participant milestones

Measure	Kineret 100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks	Placebo 100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
Overall Study STARTED	11	11
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	Kineret 100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks	Placebo 100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
Overall Study Adverse Event	3	1
Overall Study Withdrawal by Subject	0	2
Overall Study did not meet inclusion/exclusion	1	1

Baseline Characteristics

Inflammation, Proteolysis and IL-1 Beta Receptor Inhibition in Chronic Hemodialysis Patients

Baseline characteristics by cohort

Measure	Kineret n=11 Participants 100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks	Placebo n=11 Participants 100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks	Total n=22 Participants Total of all reporting groups
Age Continuous	45 years STANDARD_DEVIATION 10.5 • n=5 Participants	50 years STANDARD_DEVIATION 11.4 • n=7 Participants	47 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 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	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	3 Participants n=7 Participants	4 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

PRIMARY outcome

Timeframe: month 1

Population: The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.

hsCRP is a sensitive laboratory assay for serum levels of C-reactive protein, which is a biomarker of inflammation.

Outcome measures

Measure	Kineret n=7 Participants 100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks	Placebo n=7 Participants 100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
High Sensitivity C-reactive Protein (hsCRP)	4.67 mg/dl Standard Deviation 2.87	15.11 mg/dl Standard Deviation 10.18

SECONDARY outcome

Timeframe: month 1

Population: The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.

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

Outcome measures

Measure	Kineret n=7 Participants 100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks	Placebo n=7 Participants 100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
Interleukin-6 (IL-6)	3.34 pg/ml Standard Deviation 3.09	8.14 pg/ml Standard Deviation 6.04

SECONDARY outcome

Timeframe: month 1

Population: The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.

Prealbumin is a sensitive laboratory assay for serum levels of prealbumin, which is a biomarker of nutrition.

Outcome measures

Measure	Kineret n=7 Participants 100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks	Placebo n=7 Participants 100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
Serum Prealbumin	46.43 mg/dl Standard Deviation 11.27	33.57 mg/dl Standard Deviation 12.23

SECONDARY outcome

Timeframe: month 1

Population: The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.

Albumin is a sensitive laboratory assay for serum levels of albumin, which is a biomarker of nutrition.

Outcome measures

Measure	Kineret n=7 Participants 100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks	Placebo n=7 Participants 100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
Serum Albumin	4.26 g/dl Standard Deviation 0.40	3.95 g/dl Standard Deviation 0.38

SECONDARY outcome

Timeframe: month 1

Population: The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.

LBM is a measurement of body composition in terms of lean body mass as determined using Dual Energy X-ray Absorptiometry (DEXA) performed 1 to 2 hours after dialysis.

Outcome measures

Measure	Kineret n=7 Participants 100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks	Placebo n=7 Participants 100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
Lean Body Mass (LBM)	59.13 kg Standard Deviation 8.72	50.38 kg Standard Deviation 7.86

Adverse Events

Kineret

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

Measure	Kineret n=7 participants at risk 100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks	Placebo n=7 participants at risk 100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
Skin and subcutaneous tissue disorders injection site reaction	28.6% 2/7 • Number of events 2 • 1 month	0.00% 0/7 • 1 month
Infections and infestations hemodialysis access site infection	14.3% 1/7 • Number of events 1 • 1 month	0.00% 0/7 • 1 month
Skin and subcutaneous tissue disorders injection site hematoma	14.3% 1/7 • Number of events 1 • 1 month	0.00% 0/7 • 1 month
Blood and lymphatic system disorders thrombocytopenia	0.00% 0/7 • 1 month	14.3% 1/7 • Number of events 1 • 1 month
General disorders fatigue	14.3% 1/7 • Number of events 1 • 1 month	14.3% 1/7 • Number of events 1 • 1 month
Respiratory, thoracic and mediastinal disorders asthma	0.00% 0/7 • 1 month	14.3% 1/7 • Number of events 1 • 1 month

Additional Information

Adriana Hung, MD

Vanderbilt University

Email: adriana.hung@vanderbilt.edu

Results disclosure agreements

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