End Stage Renal DiseasePhase 2/3HCO1100NCT00974779
High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients
A Phase 2/3 study testing HCO1100 dialyzer and regular dialysis polyamide in people with End Stage Renal Disease, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
The purpose of this study is to test whether a dialyzer with a higher than usual permeability for proteins can eliminate proinflammatory proteins from the blood of patients on regular maintenance hemodialysis who have chronically elevated levels of inflammation markers such as C-reactive protein (CRP) in their blood. 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?
- HCO1100 dialyzer and regular dialysis polyamide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Dec 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- regular hemodialysis for at least 3 months
- treatment thrice weekly
- high-flux hemodialyzer for at least 4 weeks
- age > 18 years and < 80 years
- at least one CRP value > 5mg/L within 8 weeks before inclusion
- able to understand and consent the study
- written informed consent
Who cannot join
- no consent
- clinically apparent acute infection
- CRP > 50 mg/L
- serum albumin < 3,5 mg/L
- central venous line as dialysis access
- immunosuppressive medication
- pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal Medicine II, Martin-Luther-University Medical School
Halle, Saxony-Anhalt
About this study
Official title: Application of the "High-cutoff (HCO1100)" Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients With Elevated CRP Levels
The purpose of this study is to test whether a dialyzer with a higher than usual permeability for proteins can eliminate proinflammatory proteins from the blood of patients on regular maintenance hemodialysis who have chronically elevated levels of inflammation markers such as C-reactive protein (CRP) in their blood.
Read the detailed description
Patients with ESRD on chronic hemodialysis patients frequently have elevated markers of inflammation (e.g. serum CRP values). Hemodialysis may clear the blood from low molecular weight toxins and retention products such as creatinine, potassium, or urea. The dialyzer clearance of middle to high molecular weight substances such as cytokines and cytokine receptors is low. Nearly 50% of chronic dialysis patients have persistent subclinical inflammation which is strongly associated with cardiovascular disease and mortality. The study tests the hypothesis that removal of proteins in the weight range of 10.000-30.000 D via a more permeable dialyzer membrane reduces chronic inflammation in these patients.
- Conditions
- End Stage Renal Disease
- Being tested
- HCO1100 dialyzer, regular dialysis polyamide
- Keywords
- kidney failure chronic, renal dialysis, inflammation, monocytes, end stage renal disease on regular thrice weekly hemodialysis
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCO1100 dialyzerDevice
Also called Gambro HCO1100
Thrice weekly dialysis using the HCO1100 dialyzer for 4.5h, 2 weeks
regular dialysis polyamideDevice
Also called Gambro Polyflux 11
Continuation of the regular hemodialysis using polyamide high-flux hemodialysers
| Study group | Role | What they receive |
|---|---|---|
| HCO dialyzer | Experimental | Hemodialysis with the HCO1100 hemodialyzer membrane with high molecular weight cut off. Receives: Device: HCO1100 dialyzer |
| Placebo | Active comparator | Regular dialysis using a polyamide high-flux hemodialyzer Receives: Device: regular dialysis polyamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes
Measured: 2 weeks
Secondary outcomes (1)
Serum albumin losses
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- Gambro Dialysatoren GmbH, KfH Kuratorium für Dialyse und Nierentransplantation e.V., Neu Isenburg, Germany
- Responsible party
- Principal investigator, Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974779
- Sponsor's protocol ID
- KIM2H-2009-02
- Acronym
- HCO1100
- Status last verified
- Jan 2012
- First submitted
- 9 Sep 2009
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fiedler R, Neugebauer F, Ulrich C, Wienke A, Gromann C, Storr M, Bohler T, Seibert E, Girndt M. Randomized controlled pilot study of 2 weeks' treatment with high cutoff membrane for hemodialysis patients with elevated C-reactive protein. Artif Organs. 2012 Oct;36(10):886-93. doi: 10.1111/j.1525-1594.2012.01479.x. Epub 2012 Jul 30.
PubMed 22845695
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the "High-cutoff (HCO1100)" Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients With Elevated CRP Levels
- ClinicalTrials.gov ID
- NCT00974779
- Acronym / sponsor ID
- HCO1100 / KIM2H-2009-02
- Conditions
- End Stage Renal Disease
- Keywords
- kidney failure chronic, renal dialysis, inflammation, monocytes, end stage renal disease on regular thrice weekly hemodialysis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- Gambro Dialysatoren GmbH, KfH Kuratorium für Dialyse und Nierentransplantation e.V., Neu Isenburg, Germany
- Study start
- Nov 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether a dialyzer with a higher than usual permeability for proteins can eliminate proinflammatory proteins from the blood of patients on regular maintenance hemodialysis who have chronically elevated levels of inflammation markers such as C-reactive protein (CRP) in their blood.
Detailed description
Patients with ESRD on chronic hemodialysis patients frequently have elevated markers of inflammation (e.g. serum CRP values). Hemodialysis may clear the blood from low molecular weight toxins and retention products such as creatinine, potassium, or urea. The dialyzer clearance of middle to high molecular weight substances such as cytokines and cytokine receptors is low. Nearly 50% of chronic dialysis patients have persistent subclinical inflammation which is strongly associated with cardiovascular disease and mortality. The study tests the hypothesis that removal of proteins in the weight range of 10.000-30.000 D via a more permeable dialyzer membrane reduces chronic inflammation in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCO dialyzer | Experimental | Device: HCO1100 dialyzerHemodialysis with the HCO1100 hemodialyzer membrane with high molecular weight cut off. |
| Placebo | Active comparator | Device: regular dialysis polyamideRegular dialysis using a polyamide high-flux hemodialyzer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- regular hemodialysis for at least 3 months
- treatment thrice weekly
- high-flux hemodialyzer for at least 4 weeks
- age > 18 years and < 80 years
- at least one CRP value > 5mg/L within 8 weeks before inclusion
Key exclusion criteria (7 listed)
- no consent
- clinically apparent acute infection
- CRP > 50 mg/L
- serum albumin < 3,5 mg/L
- central venous line as dialysis access
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 |
|---|---|---|
| HCO1100 dialyzerAlso: Gambro HCO1100Thrice weekly dialysis using the HCO1100 dialyzer for 4.5h, 2 weeks | Device | HCO dialyzer |
| regular dialysis polyamideAlso: Gambro Polyflux 11Continuation of the regular hemodialysis using polyamide high-flux hemodialysers | Device | Placebo |
Primary outcome
Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes
Time frame: 2 weeks
1 secondary outcome
Serum albumin losses
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
- Derived from this study: PubMed 22845695Fiedler R, Neugebauer F, Ulrich C, Wienke A, Gromann C, Storr M, Bohler T, Seibert E, Girndt M. Randomized controlled pilot study of 2 weeks' treatment with high cutoff membrane for hemodialysis patients with elevated C-reactive protein. Artif Organs. 2012 Oct;36(10):886-93. doi: 10.1111/j.1525-1594.2012.01479.x. Epub 2012 Jul 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HCO1100 dialyzer and regular dialysis polyamide in people with End Stage Renal Disease, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 18 Jan 2012. 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 Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes (time frame: 2 weeks). 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 NCT00974779, 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 18 Jan 2012.