End Stage Renal DiseasePhase 2NCT00293202

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

A Phase 2 study testing Etanercept in people with End Stage Renal Disease, run by Kaysen, George A., M.D., Ph.D. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Etanercept is a novel anti-inflammatory agent currently used in patients with rheumatoid arthritis. We are examining whether Etanercept is effective in improving the nutritional status of hemodialysis patients as a consequence of its ability to decrease inflammation. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: End Stage Renal Disease
What is being tested?: Etanercept
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Jan 2005to Jun 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Presence of end stage renal disease

Who cannot join

History of Tuberculosis History of Recurrent Infection Recent AMI, Cancer within previous 5 years Presence of Hepatitis B, Hepatitis C, HIV, systemic lupus erythematosis, presence of transcutaneous access (external catheter)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, Davis, Medical Center
Sacramento, California, 95817

Other trials in United States

About this study

Official title: The Effect of Etanercept in Suppression of the Systemic Inflammatory Response in Hemodialysis Patients

Read the detailed description

Hemodialysis patients with end stage renal disease have a high mortality rate. In individual patients, mortality is associated with a low serum albumin concentration, a marker of poor nutritional status, and with elevated C-reactive protein, a marker of inflammation. Since efforts to improve nutrition through dietary intake have not been successful, inflammation is thought to play a key role in determining nutritional status. Recently, it has been shown that malnutrition, inflammation, and atherosclerosis are closely related in patients with chronic renal failure. It is our hypothesis that suppression of the cycle of inflammation, malnutrition, and vascular injury caused by atherosclerosis will improve survival in dialysis patients. This study is designed to examine whether suppression of the inflammatory response can be accomplished safely with Etanercept and to determine if this suppression will improve nutritional status and clinical outcome in hemodialysis patients with poor nutritional status and evidence of inflammation.

Conditions: End Stage Renal Disease
Being tested: Etanercept, Placebo
Keywords: etanercept, malnutrition, inflammation, hemodialysis
Medical subject headings: Kidney Failure, Chronic, Malnutrition, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EtanerceptDrug
Also called Enbrel
Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week
PlaceboDrug
Also called Saline
Hemodialysis patients will receive Saline by subcutaneous injection twice a week

Study groups in NCT00293202
Study group	Role	What they receive
Etanercept 25 mg	Active comparator	Etanercept 25 mg injection twice a week Receives: Drug: Etanercept
Saline	Placebo comparator	Saline injection twice a week Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Albumin
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.
Measured: 52 weeks
C-reactive Protein
A reduced C-reactive protein (CRP) concentration is expected.
Measured: 52 weeks

Secondary outcomes (1)

Prealbumin (mg/dL)
Effect of treatment on prealbumin (PAB) concentration
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Jun 2010

First posted17 Feb 2006 (estimated)
Study startJan 2005
Primary completionMar 2008
Study completionJun 2010

Why it stopped: We were unable to recruit sufficient patients within the confines of our budget considering the restrains on our recruitment criteria

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a double blind study- one group received 25mg Etanercept twice per week; the other is control - receiving saline twice per week
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00293202
Sponsor's protocol ID: 200311904
Status last verified: Jul 2021
First submitted: 15 Feb 2006
Last updated: 13 Jul 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

Don BR, Kim K, Li J, Dwyer T, Alexander F, Kaysen GA. The effect of etanercept on suppression of the systemic inflammatory response in chronic hemodialysis patients. Clin Nephrol. 2010 Jun;73(6):431-8. doi: 10.5414/cnp73431.
PubMed 20497755

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Etanercept in Suppression of the Systemic Inflammatory Response in Hemodialysis Patients
ClinicalTrials.gov ID: NCT00293202
Acronym / sponsor ID: 200311904
Conditions: End Stage Renal Disease
Keywords: etanercept, malnutrition, inflammation, hemodialysis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: We were unable to recruit sufficient patients within the confines of our budget considering the restrains on our recruitment criteria
Enrolment: 10 participants (actual)
Lead sponsor: Kaysen, George A., M.D., Ph.D.University, hospital or other
Collaborators: Amgen, Dialysis Clinic, Inc.
Study start: Jan 2005 (actual)
Primary completion: Mar 2008 (actual)
Study completion: Jun 2010 (actual)
First posted: 17 Feb 2006 (estimated)
Results: Posted 28 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: This is a double blind study- one group received 25mg Etanercept twice per week; the other is control - receiving saline twice per week

Arm	Type	Receives
Etanercept 25 mg	Active comparator	Drug: EtanerceptEtanercept 25 mg injection twice a week
Saline	Placebo comparator	Drug: PlaceboSaline injection twice a week

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Presence of end stage renal disease

Key exclusion criteria (1 listed)

History of Tuberculosis History of Recurrent Infection Recent AMI, Cancer within previous 5 years Presence of Hepatitis B, Hepatitis C, HIV, systemic lupus erythematosis, presence of transcutaneous access (external catheter)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EtanerceptAlso: EnbrelHemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week	Drug	Etanercept 25 mg
PlaceboAlso: SalineHemodialysis patients will receive Saline by subcutaneous injection twice a week	Drug	Saline

Primary outcome

Albumin
Time frame: 52 weeks
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.
C-reactive Protein
Time frame: 52 weeks
A reduced C-reactive protein (CRP) concentration is expected.

1 secondary outcome

Prealbumin (mg/dL)
Time frame: 52 weeks

Results and safety

Results posted to the registry on 28 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etanercept	5	2
Placebo	5	3

Primary outcome: Albumin

Time frame: 52 weeks. Mean (Standard Deviation). Unit: g/dL

Measure	Etanercept n = 5	Placebo n = 5
Value	3.34 (0.22)	3.42 (0.25)

Population analysed: 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.

Primary outcome: C-reactive Protein

Time frame: 52 weeks. Mean (Standard Deviation). Unit: mg/L

Measure	Etanercept n = 5	Placebo n = 5
Value	28.96 (26.00)	11.94 (13.53)

Population analysed: 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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etanercept	0 of 5 (0%)	1 of 5 (20%)	0 of 5
Placebo	3 of 5 (60%)	1 of 5 (20%)	0 of 5

Limitations and caveats (from the sponsor): Only 10 out of 40 subjects recruited. Only 5 out of 10 subject randomized completed the study. The study has been slow to accrue patients due to the large number and stringent inclusion and exclusion criteria so as to optimize safety. This is due to Etanercept as an anti-inflammatory agent that acts directly on a key regulatory protein in the immune system, tumor necrosis factor α. Extreme stringency was intended to prevent the potential unmasking of latent infection.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20497755Don BR, Kim K, Li J, Dwyer T, Alexander F, Kaysen GA. The effect of etanercept on suppression of the systemic inflammatory response in chronic hemodialysis patients. Clin Nephrol. 2010 Jun;73(6):431-8. doi: 10.5414/cnp73431.
B.R. Don, K.Kim, J. Li, T. Dwyer, F. Alexander and G.A. Kaysen.The effect of etanercept on suppression of the systemic inflammatory response in chronic hemodialysis patients. 2010; 73: 431-438. doi: 10.5414/CNP73431Link provided by the sponsor.

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

George Kaysen, MD, PhD principal investigator

University of California, Davis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Etanercept in people with End Stage Renal Disease, run by Kaysen, George A., M.D., Ph.D. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Albumin (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00293202, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.