Chronic Kidney Disease Trial, Recruiting NCT06341452 Sponsor: Fresenius Medical Care Deutschland GmbH Condition: Chronic Kidney Disease
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Chronic Kidney Disease Trial, Recruiting

NCT06341452
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:

  • People who are at least 18 years old and able to understand and consent to taking part in the trial
  • People who have been diagnosed with end-stage kidney disease (the most advanced stage of chronic kidney disease, where the kidneys are functioning at 15 ml/min or less)
  • People who have been receiving dialysis (haemodialysis or haemodiafiltration) for at least 3 months, with sessions lasting at least 4 hours, three times per week, using a standard salt concentration in the dialysis fluid of 136 mmol/L
  • People whose urine output is very low (less than 300 mL per day, confirmed by a measurement taken within the last 4 weeks)
  • People who meet at least one of the following conditions during the lead-in period: gaining more than 4% of their dry body weight between dialysis sessions; having a pre-dialysis top blood pressure reading above 180 mmHg; experiencing at least three dialysis sessions with problems such as low blood pressure, high blood pressure, cramps, or headaches; or having excess fluid in the body of a certain level as measured by a body composition monitor
  • People whose dialysis treatment results in a measurable level of sodium being added to the body (confirmed with trial site)

Who may not be able to join:

  • People who are unable to give informed consent, or who have a condition that may prevent them from following the study requirements
  • Women who are pregnant or breastfeeding (women aged 55 or under will be given a pregnancy test at the start and end of the study)
  • People who have taken part in another interventional clinical trial in the past 30 days, or who have previously participated in this same study
  • People who have had personalised sodium management as part of their dialysis care in the last 3 months
  • People with very low albumin levels in their blood (30 g/L or below, based on a test within the last 4 weeks)
  • People with higher-than-normal sodium levels in their blood before dialysis (145 mmol/L or above, based on a test within the last 4 weeks)
  • People with diabetes whose long-term blood sugar control measure (HbA1c) is above 8%, based on a test within the last 4 weeks
  • People for whom body composition measurement by bioimpedance is not reliable — for example, those with a lower limb amputation, a certain type of pacemaker, or metallic prostheses
  • People whose life expectancy is less than 6 months
  • People receiving certain specific types of dialysis treatment, including ONLINEplus HF, haemofiltration, or single-needle treatments
  • People with a dry body weight below 40 kg
  • People with active or chronic infections including HIV, COVID-19 (SARS-CoV-2), hepatitis B, or hepatitis C

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 7 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

Principal Investigator: Martin Jirovec, Dr., Fresenius Medical Care - DS, s.r.o., Marianske Lazne; Czech Republic

Phone: +49 6172 608 93488

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

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Fresenius Medical Care Deutschland GmbH
Registry
ClinicalTrials.gov
Start date
16 December 2025
Est. completion
1 December 2026

Where this trial is recruiting

🇨🇿 Czechia

Primary endpoints

Interdialytic weight gain; Intradialytic hemodynamic stability; Intradialytic hemodynamic stability; Intradialytic morbid events; Fluid status; Fluid status

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: 7 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