Trial Outcomes & Findings for Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients (NCT NCT00293202)

Last Updated: 2021-07-13

Results Overview

An increased serum albumin (ALB) concentration expected. Higher concentrations of Albumin indicate better outcome. Normal ranges of Albumin in this study is from 3.5 to 5.5 gram per deciliter (g/dL). We expect ALB to remain or increase in this study.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

52 weeks

Results posted on

2021-07-13

Participant Flow

The protocol was approved by the Human Subjects Review Committee of the University of California Davis Medical Center and Dialysis Clinics, Incorporated. Screening started in January 2005, and had to be terminated early due to low enrollment in December 2006

Subject was consented and screened for safety. Then they have to qualify for 3 monthly screening values. Once deemed qualified for the study, subject then randomized into a double-blind study; to follow regimen of protocols and followed to 52 weeks of study.

Participant milestones

Participant milestones
Measure	Etanercept Active Comparator: Etanercept 25 mg injection twice a week 1. 5 Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week 2. Do not have active infections 3. Patient will be followed for 52 weeks	Placebo Placebo comparator: Saline injection twice a week 1. 5 Hemodialysis patients will receive Saline by subcutaneous injection twice a week 2. Do not have active infections 3. Patient will be followed for 52 weeks
Overall Study STARTED	5	5
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Etanercept Active Comparator: Etanercept 25 mg injection twice a week 1. 5 Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week 2. Do not have active infections 3. Patient will be followed for 52 weeks	Placebo Placebo comparator: Saline injection twice a week 1. 5 Hemodialysis patients will receive Saline by subcutaneous injection twice a week 2. Do not have active infections 3. Patient will be followed for 52 weeks
Overall Study Withdrawal by Subject	1	2
Overall Study positive ANA (antinuclear antibody)	1	0
Overall Study on-hold due to fistula maturation time	1	0

Baseline Characteristics

Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etanercept n=5 Participants Etanercept 25 mg injection twice a week Etanercept: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week	Placebo n=5 Participants Saline injection twice a week Placebo: Hemodialysis patients will receive Saline by subcutaneous injection twice a week	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	51 years STANDARD_DEVIATION 16.739 • n=5 Participants	55 years STANDARD_DEVIATION 15.209 • n=7 Participants	53 years STANDARD_DEVIATION 15.101 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	5 Participant n=5 Participants	5 Participant n=7 Participants	10 Participant n=5 Participants
C-Reactive Protein (CRP)	29.05 mg/L STANDARD_DEVIATION 15.60 • n=5 Participants	10.98 mg/L STANDARD_DEVIATION 3.95 • n=7 Participants	15.79 mg/L STANDARD_DEVIATION 28.13 • n=5 Participants
Albumin	3.39 g/dL STANDARD_DEVIATION 0.24 • n=5 Participants	3.31 g/dL STANDARD_DEVIATION 0.21 • n=7 Participants	3.37 g/dL STANDARD_DEVIATION 0.20 • n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: Hemodialysis patients have a high mortality rate caused by poor nutrition and inflammation. The hypothesis is that suppression of inflammation reverses the malnutrition-inflammation syndrome in hemodialysis patients. Etanercept is an anti-inflammatory agent. Thus it is expected that participant given Etanercept will have a reduced amount of inflammation in their bodies and have better nutritional status - indicated by an increase/steady Albumin level.

Outcome measures

Outcome measures
Measure	Etanercept n=5 Participants Active comparator: Etanercept 25 mg injection twice a week Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week for a total of 52 weeks.	Placebo n=5 Participants No Drug: Saline injection twice a week Hemodialysis patients will receive Saline by subcutaneous injection twice a week for a total of 52 weeks
Albumin	3.34 g/dL Standard Deviation 0.22	3.42 g/dL Standard Deviation 0.25

PRIMARY outcome

Timeframe: 52 weeks

Population: Malnutrition, inflammation, and atherosclerosis affect patients with chronic renal failure. High C-reactive protein is a marker of inflammation. This study is designed to examine whether suppression of the inflammatory response can be accomplished safely with Etanercept. For those who has high CRP level, we expect that CRP level will be reduced

A reduced C-reactive protein (CRP) concentration is expected.

Outcome measures

Outcome measures
Measure	Etanercept n=5 Participants Active comparator: Etanercept 25 mg injection twice a week Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week for a total of 52 weeks.	Placebo n=5 Participants No Drug: Saline injection twice a week Hemodialysis patients will receive Saline by subcutaneous injection twice a week for a total of 52 weeks
C-reactive Protein	28.96 mg/L Standard Deviation 26.00	11.94 mg/L Standard Deviation 13.53

SECONDARY outcome

Timeframe: 52 weeks

Population: Serum Prealbumin is measured in milligram per deciliter (mg/dL). Increase number is a measured of better nutritional status. In the etanercept group we would expect fewer decreases in prealbumin. Decreased level of prealbumin may indicate inflammations may be occurring in the body.

Effect of treatment on prealbumin (PAB) concentration

Outcome measures

Outcome measures
Measure	Etanercept n=5 Participants Active comparator: Etanercept 25 mg injection twice a week Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week for a total of 52 weeks.	Placebo n=5 Participants No Drug: Saline injection twice a week Hemodialysis patients will receive Saline by subcutaneous injection twice a week for a total of 52 weeks
Prealbumin (mg/dL)	32.36 mg/dL Standard Deviation 8.64	31.43 mg/dL Standard Deviation 8.83

Adverse Events

Etanercept

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Etanercept n=5 participants at risk Etanercept 25 mg injection twice a week Etanercept: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week	Placebo n=5 participants at risk Saline injection twice a week Placebo: Hemodialysis patients will receive Saline by subcutaneous injection twice a week
Gastrointestinal disorders Epigastric pain	0.00% 0/5 • 12 months Adverse Event collected was in the same category as defined	20.0% 1/5 • Number of events 1 • 12 months Adverse Event collected was in the same category as defined
Nervous system disorders Stroke	0.00% 0/5 • 12 months Adverse Event collected was in the same category as defined	20.0% 1/5 • Number of events 1 • 12 months Adverse Event collected was in the same category as defined
Cardiac disorders CABG	0.00% 0/5 • 12 months Adverse Event collected was in the same category as defined	20.0% 1/5 • Number of events 1 • 12 months Adverse Event collected was in the same category as defined
Cardiac disorders Ventricular Fibrillation	0.00% 0/5 • 12 months Adverse Event collected was in the same category as defined	20.0% 1/5 • Number of events 1 • 12 months Adverse Event collected was in the same category as defined

Other adverse events

Other adverse events
Measure	Etanercept n=5 participants at risk Etanercept 25 mg injection twice a week Etanercept: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week	Placebo n=5 participants at risk Saline injection twice a week Placebo: Hemodialysis patients will receive Saline by subcutaneous injection twice a week
Skin and subcutaneous tissue disorders Skin pain	0.00% 0/5 • 12 months Adverse Event collected was in the same category as defined	20.0% 1/5 • Number of events 1 • 12 months Adverse Event collected was in the same category as defined
General disorders Cold symptoms	0.00% 0/5 • 12 months Adverse Event collected was in the same category as defined	20.0% 1/5 • Number of events 1 • 12 months Adverse Event collected was in the same category as defined
General disorders Hematuria, chest pain, nausea and vomiting	20.0% 1/5 • Number of events 1 • 12 months Adverse Event collected was in the same category as defined	0.00% 0/5 • 12 months Adverse Event collected was in the same category as defined

Additional Information

George Kaysen MD PhD

University of California, Davis

Phone: 916-734-3774

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place