Clinical Trials Logo

Clinical Trial Summary

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. The primary treatment modality is currently hemodialysis. It is known to activate the coagulation cascade and blood platelets, leading to thrombus formation and premature termination of the hemodialysis session. This loss of circuitry results in a decrease in session time leading to an insufficient dialysis dose and blood loss in patients who are already often anemic due to their chronic renal failure. To avoid this complication, current recommendations recommend the use of unfractionated heparin (UFH) or low molecular weight heparin (LMWH) during the hemodialysis session at the cost of an obligatory hemorrhagic risk due to the systemic administration of heparin. However, this risk of bleeding is already very high, due to platelet dysfunction, a direct consequence of uremic toxin impregnation in these patients. In addition, this hemodialysis population is frequently exposed to antiplatelet agents and anticoagulants (heparin or VKA), which aggravate the hemorrhagic risk inherent to renal pathology. In this context, bioactive membranes such as the HeprAN™ membrane, coated in heparin, have been developed to minimize or even eliminate the need for anticoagulation during sessions in chronic hemodialysis patients. Several studies with this membrane have demonstrated the absence of the need for additional heparin in populations with no particular bleeding risk and in populations at risk of bleeding: post-operative (HepZero study), patients on VKA. The HYDROLINK™ membrane offers the same anticoagulant prospects as the HeprAN™ membrane, but its mode of action involves the use of a copolymer with hydrophilic properties, making it possible to avoid the presence of heparin. This membrane would have an influence on platelet aggregation. It would also make it possible to avoid the risk of heparin-induced thrombocytopenia (HIT) by completely excluding heparin from the dialysis session


Clinical Trial Description

The aim of this study is to compare the HYDROLINK™ membrane to the HeprAN™ membrane in a large-scale trial with the strategy of minimizing the dose of peridialytic heparin in order to reduce the risk of bleeding in chronic hemodialysis patients. Participation in the research will be offered at the time of a hemodialysis session to any eligible patient, i.e., over 18 years of age, who has been on chronic hemodialysis for at least 3 months at a rate of three times a week and who has given their consent to this study. A cross over trial will be performed. Each included patient will have hemodialysis sessions with HYDROLINK™ and HeprAN™ membrane. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05117450
Study type Interventional
Source CHU de Reims
Contact Antoine BRACONNIER
Phone 03 26 78 41 40
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date December 2021
Completion date April 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04096547 - Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
Completed NCT04024332 - Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects Phase 1
Completed NCT02849964 - Factors Related to Geographical Variation in the Incidence of End-stage Renal Failure: An Analysis in 5 French Regions N/A
Active, not recruiting NCT03672110 - Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen Phase 3
Completed NCT01407874 - A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency Phase 2
Completed NCT01462136 - PK Study of ACHN-490 Injection in Renally Impaired Subjects Phase 1
Completed NCT01172431 - Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency Phase 4
Completed NCT00765830 - Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension) Phase 3
Completed NCT00770081 - Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study) Phase 3
Completed NCT01545531 - Two-Point Measurement of Glomerular Filtration Rate by Iohexol Plasma Disappearance N/A
Terminated NCT00338455 - Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC Phase 2
Completed NCT00159614 - Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment Phase 2
Recruiting NCT04241666 - Sonographic Examination of Renal Function in Individuals With Long-term Spinal Cord Injury
Completed NCT02894905 - A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of AL-335 Phase 1
Completed NCT02894385 - Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201) Phase 1
Recruiting NCT04876963 - HOLT-ED: Holter-monitoring in End-stage Renal Disease
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Completed NCT03235375 - A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects Phase 1
Recruiting NCT03329612 - Remote Ischemic Preconditioning in ACS Patients N/A
Recruiting NCT02578784 - DEB-after-Cutting Balloon-PTA in Dialysis Fistula Stenosis N/A