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New treatment option for Renal Insufficiency
Official title Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients
ClinicalTrials.gov ID: NCT05117450
What this study is testing
- What it's testing
- Chronic kidney disease (CKD) results from the progressive and irreversible destruction of the kidneys. As of December 31, 2018, there were 89,692 people in France undergoing replacement therapy, including 49,271 (55%) on dialysis and 40,421 (45%) with a functioning kidney transplant.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with Age \> 18 years
- Chronic hemodialysis for at least 3 months
- Hemodialysis three times a week
- On per dialytic heparin therapy (UFH or LMWH)
- Affiliated to the French Social Security
You likely can't join if
- Patients undergoing Hemodiafiltration (HDF)
- Pregnant or lactating woman
- Patient participating in another treatment study
- Persons deprived of liberty by judicial or administrative decision
- Adults under legal protection (under guardianship or curators)
- Persons under a legal protection measure
See the full eligibility criteria
- Patients with Age \> 18 years
- Chronic hemodialysis for at least 3 months
- Hemodialysis three times a week
- On per dialytic heparin therapy (UFH or LMWH)
- Affiliated to the French Social Security
- Having given their consent for this study
- Patients undergoing Hemodiafiltration (HDF)
- Pregnant or lactating woman
- Patient participating in another treatment study
- Persons deprived of liberty by judicial or administrative decision
- Adults under legal protection (under guardianship or curators)
- Persons under a legal protection measure
- Patients with a history of HIT
- Patients with acquired or congenital coagulation disorders
- Pathology with active neoplasia (Myeloma, Waldenström disease, solid cancers)
- Patient on an ACE inhibitor (ACE inhibitor)
- Patient requiring transfusion during the study period
- Patient not hemoglobin-stabilized (mean Hb \ 12 g/dL in the previous month)
- Patient septic or with significant inflammation (defined as C-reactive protein \> 25mg/L) at the time of inclusion
- Patient requiring per-dialytic parenteral nutrition
- Patient requiring hospitalization or scheduled surgery during the study period
- Vascular access (Arteriovenous Fistula or Arteriovenous graft with the possibility of 2 needles) not allowing a sufficient blood pump flow (\< 300 mL/min determined during the screening phase = blood flow prescribed by...
- Patient dialyzing on catheter ("single line" or "double line") or in unipuncture on Arteriovenous fistula on the day of the screening session
- Net ultrafiltration on the day of the screening session \> 4000 mL
The study team makes the final eligibility decision.
Where it's taking place
- Reims, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Reims, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.