End Stage Renal DiseasePERCINCT01582893
Permeability Enhancement to Reduce Chronic Inflammation
A study testing HCO1100 and P210H in people with End Stage Renal Disease and Inflammation, run by Vantive Health LLC at 2 sites in Germany.
Trial summary
Chronic dialysis patients with end stage renal disease have an increased mortality rate as compared to the age matched healthy population. It is known that chronic inflammation contributes to the high incidence of cardiovascular events in chronic dialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- End Stage Renal Disease, Inflammation
- What is being tested?
- HCO1100 and P210H
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2012to Jul 2013
- Phase
- Interventional
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dialysis treatment for ≥ 3 months
- Dialysis 3x weekly
- Vascular access by fistula or CVC providing QB of ≥ 250 ml/min
- Dialysis with high-flux dialyzer for a minimum of 2 weeks before begin of study
- CRP > 5mg/L at least once within 12 weeks before inclusion
- Age > 18 and < 99 Years
- Ability to give written informed consent
Who cannot join
- Missing informed consent form
- Clinically manifested infection or current CRP-value > 50mg/L
- Serum albumin < 35g/L
- Intake of immune suppressive medication
- Pregnancy or lactation
- Participation in a different study
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
KfH-Bismarkstrasse 95-96
Berlin, 10625
KfH Bachstzelzenweg 4
Halle, Saxony-Anhalt, 06120
About this study
Chronic dialysis patients with end stage renal disease have an increased mortality rate as compared to the age matched healthy population. It is known that chronic inflammation contributes to the high incidence of cardiovascular events in chronic dialysis patients. Dialyzers made by membranes with increased pore size (high cut-off Dialyzer HCO1100) may be beneficial in the elimination of inflammatory mediators and may improve the inflammatory status. Hypothesis: In this study it will be investigated whether the treatment with HCO1100 will improve the inflammatory status of chronic dialysis patients.
- Conditions
- End Stage Renal Disease, Inflammation
- Being tested
- HCO1100, P210H
- Keywords
- inflammation, dialysis
- Medical subject headings
- Kidney Failure, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCO1100Device
Dialysis
P210HDevice
Dialysis
| Study group | Role | What they receive |
|---|---|---|
| HCO1100-P14L | Experimental | HCO1100 is connected in row with low flux dialyzer P14L Receives: Device: HCO1100 |
| P210H | Active comparator | High flux Filter P210H Receives: Device: P210H |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of CD162 expression on monocytes
change of CD162 expression on monocytes, timepoints in each treatment phase: 1.)1st.day (prae dialysis) 2.)1st.day (post dialysis) 3.)2nd.day (prae dialysis) 4.)8th.day (prae dialysis) 5.)15th.day (prae dialysis) 6.)22nd.day (prae dialysis)
Measured: 8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)
Secondary outcomes (1)
Albumin blood level
change of albumin blood level, timepoints in each treatment phase: 1.)1st.day (prae dialysis) 2.)1st.day (post dialysis) 3.)2nd.day (prae dialysis) 4.)8th.day (prae dialysis) 5.)15th.day (prae dialysis) 6.)22nd.day (prae dialysis)
Measured: 8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gambro Dialysatoren GmbH, Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Matthias Girndt, MD, Study director, Martin-Luther-Universität Halle-WittenbergRalf Schindler, MD, Principal investigator, Charité, Humboldt Universität Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582893
- Sponsor's protocol ID
- 1492
- Other IDs
- CIV-11-10-002741
- Acronym
- PERCI
- Status last verified
- Mar 2025
- First submitted
- 11 Apr 2012
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Permeability Enhancement to Reduce Chronic Inflammation
- ClinicalTrials.gov ID
- NCT01582893
- Acronym / sponsor ID
- PERCI / 1492
- Conditions
- End Stage Renal Disease, Inflammation
- Keywords
- inflammation, dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Gambro Dialysatoren GmbH, Baxter Healthcare Corporation
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Apr 2012 (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.
Chronic dialysis patients with end stage renal disease have an increased mortality rate as compared to the age matched healthy population. It is known that chronic inflammation contributes to the high incidence of cardiovascular events in chronic dialysis patients. Dialyzers made by membranes with increased pore size (high cut-off Dialyzer HCO1100) may be beneficial in the elimination of inflammatory mediators and may improve the inflammatory status. Hypothesis: In this study it will be investigated whether the treatment with HCO1100 will improve the inflammatory status of chronic dialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCO1100-P14L | Experimental | Device: HCO1100HCO1100 is connected in row with low flux dialyzer P14L |
| P210H | Active comparator | Device: P210HHigh flux Filter P210H |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Dialysis treatment for ≥ 3 months
- Dialysis 3x weekly
- Vascular access by fistula or CVC providing QB of ≥ 250 ml/min
- Dialysis with high-flux dialyzer for a minimum of 2 weeks before begin of study
- CRP > 5mg/L at least once within 12 weeks before inclusion
Key exclusion criteria (6 listed)
- Missing informed consent form
- Clinically manifested infection or current CRP-value > 50mg/L
- Serum albumin < 35g/L
- Intake of immune suppressive medication
- Pregnancy or lactation
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 |
|---|---|---|
| HCO1100Dialysis | Device | HCO1100-P14L |
| P210HDialysis | Device | P210H |
Primary outcome
change of CD162 expression on monocytes
Time frame: 8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)
change of CD162 expression on monocytes, timepoints in each treatment phase: 1.)1st.day (prae dialysis) 2.)1st.day (post dialysis) 3.)2nd.day (prae dialysis) 4.)8th.day (prae dialysis) 5.)15th.day (prae dialysis) 6.)22nd.day (prae dialysis)
1 secondary outcome
Albumin blood level
Time frame: 8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)
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 13 Mar 2025.
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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.
Matthias Girndt, MD study director
Martin-Luther-Universität Halle-Wittenberg
Ralf Schindler, MD principal investigator
Charité, Humboldt Universität Berlin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCO1100 and P210H in people with End Stage Renal Disease and Inflammation, run by Vantive Health LLC at 2 sites 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 6 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 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
change of CD162 expression on monocytes (time frame: 8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2025.