Chronic Kidney Disease Trial, Recruiting NCT06224140 Sponsor: Assistance Publique Hopitaux De Marseille Condition: Chronic Kidney Disease
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Chronic Kidney Disease Trial, Recruiting

NCT06224140
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 years or older.
  • People with end-stage kidney disease who have been receiving intermittent hemodialysis (kidney dialysis) for more than 3 months before the screening visit, with each dialysis session lasting at least 4 hours.
  • People whose dialysis sessions have been effectively managed with blood-thinning medication (either UFH or LMWH), with no loss of the dialysis circuit in the last 3 months.
  • People whose dialysis is working adequately, as measured by a standard test called Kt/V, with an average result of 1.2 or higher.
  • People whose blood calcium levels are within the normal range (2.2 to 2.6 mmol/L), based on the most recent monthly blood test.
  • People who are enrolled in or covered by a social security system.
  • People who have signed a written consent form agreeing to take part in the study.

Who may not be able to join:

  • People whose dialysis access point (the entry point used for dialysis) is not working properly at the time of screening.
  • People who use a single needle for their dialysis access (called unipuncture of the AVF).
  • People currently receiving hemofiltration or hemodiafiltration (other types of kidney filtering treatments, different from standard hemodialysis).
  • People currently taking ongoing blood-thinning (anticoagulation) medication outside of dialysis.
  • People currently being treated with digitalis-based heart medications (a specific type of heart drug).
  • People currently taking thiazide diuretics (a type of water tablet used to reduce fluid).
  • People with high calcium levels in the blood or urine (hypercalcemia or hypercalciuria).
  • People with a known history of allergy to heparin or a condition called heparin-induced thrombocytopenia (a serious reaction to heparin that affects blood platelets).
  • People with active bleeding.
  • People considered at high risk of bleeding, including those who have had bleeding, surgery, a head injury, or an ischemic stroke (a type of stroke caused by a blood clot) within the past 7 days, or who have a condition called uremic pericarditis (inflammation around the heart related to kidney disease).
  • People whose body weight is below 45 kg or above 140 kg at screening.
  • People with a known allergy to citrate.
  • People who are in hospital at the time of screening for any reason other than their regular dialysis.
  • People whose health is so critical that death is expected within three months.
  • People with liver failure, based on their most recent blood test results (confirm with trial site for exact threshold used).
  • People currently participating in another clinical trial involving dialysis or blood-thinning treatments.
  • People who are pregnant or breastfeeding, and other groups with special legal protections under French health law, including people under legal guardianship, people hospitalised without their consent, people in social or health care facilities for treatment rather than research, and people in emergency situations.
  • People who are unable or unwilling to give informed consent to take part in the study.
  • People whose current dialysis prescription uses a heparin-coated membrane (a special type of dialysis filter treated with heparin).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 04 91 38 41 17

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
6 June 2024
Est. completion
1 September 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Demonstrate the non-inferiority of the regional anticoagulation procedure compared to heparin anticoagulation on the dialysis sessions success three times per week

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov