Kidney Disease, ChronicReDeDiaNCT07718568
Impact of Reducing the Dialysate Flow Rate in Chronic Hemodialysis on Dialysis Quality and Environmental Impact on Water Consumption
A study testing Dialysate flow at 400mL/min and Dialysate flow at 500mL/min in people with Kidney Disease, Chronic, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
In France, 60,000 patients are receiving renal replacement therapy via dialysis in 2022, 90% of whom are on hemodialysis. This technique is based on the principle of exchange across a membrane between the patient's blood and the dialysate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease, Chronic
- What is being tested?
- Dialysate flow at 400mL/min and Dialysate flow at 500mL/min
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2027to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- No decompensated psychiatric disorder, acute or decompensated somatic condition
- Patients on hemodialysis for more than 3 months
- Dialysis schedule: 3 times per week for 4 hours each session
- Stable vascular access (arteriovenous fistula or tunneled central catheter)
- Blood flow > 300 mL/min
- Anuric (urine output < 500 mL/24 h)
- Dialysis method: hemodialysis or hemodiafiltration
Who cannot join
- Age < 18 years
- Patient on dialysis for < 3 months
- Unstable vascular access
- Blood flow rate < 300 mL/min
- Urine output > 500 mL/day
- Dialysis technique: hemofiltration
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- Severe intercurrent condition (somatic or psychiatric)
- Pregnant or breastfeeding patients.
- Patients who are legally incapacitated, under guardianship, or under conservatorship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Assistance Publique - Hôpitaux de Marseille
Marseille
Romain Vial, Dr, 04913883569 ext. +33, romain.vial@ap-hm.fr
About this study
Official title: Non-inferiority Study on the Efficacy of Hemodialysis With Dialysate Flow Rates of 400 mL/Min Versus 500 mL/Min in a Population of Patients Undergoing Chronic Hemodialysis. Impact of Reducing the Dialysate Flow Rate in Chronic Hemodialysis on Dialysis Quality and Environmental Impact on Water Consumption
In France, 60,000 patients are receiving renal replacement therapy via dialysis in 2022, 90% of whom are on hemodialysis. This technique is based on the principle of exchange across a membrane between the patient's blood and the dialysate. The goal is to purify the patient's blood as effectively as possible by removing all solutes that have accumulated due to kidney failure. The dialysate is produced from municipal water, which is treated through several processes (reverse osmosis, filtration) to produce ultrapure water. Water consumption at the La Conception Hospital center in Marseille, which conducts 37,000 sessions per year (64 hemodialysis stations), is estimated at 120 m³ of water per day, which is discharged into the sewer system after use. In France, this would correspond to an estimated total consumption of nearly one million m³ of drinking water per year. In the context of climate change, which will lead to a reduction in water resources, it is important to rethink all aspects of water consumption. The investigator's reflection is part of a growing awareness of the environmental impact of dialysis within a working group of the Francophone Society of Nephrology, Dialysis, and Transplantation: "Green Dialysis." The quality of clearance depends on blood flow and dialysate flow rate (Qd). The Qd was set at 500 mL/min based on earlier studies that showed this flow rate corresponded to maximum clearance of urea and the main toxic solutes. These studies were conducted at a time when dialysis membranes were less efficient. Today, the investigators use membranes with higher exchange efficiency. Despite this, the investigators have not reevaluated the appropriateness of a Qd of 500 mL/min. The quality criterion in dialysis is a balanced urea Kt/V measurement >1.2 for a 4-hour session (target set at 1.4 with certain "single-pool" dialysis machine measurement techniques). At the ivnestigator's center, the average urea Kt/V is 1.55 in "single-pool" mode. Reducing the Qd could be done without risk to patients, even if it leads to a decrease in urea Kt/V. A Colombian study with 5 years of follow-up demonstrates patient safety with a Qd of 400 mL/min (vs. 500 mL/min), with no difference in mortality or dialysis efficacy. The study population was not representative of chronic dialysis patients; 10% regained renal function, and the final analysis included only 25 of the 71 patients enrolled.
- Conditions
- Kidney Disease, Chronic
- Being tested
- Dialysate flow at 400mL/min, Dialysate flow at 500mL/min
- Keywords
- Efficicency or Quality of Hemodialysis, Green Dialysis
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysate flow at 400mL/minOther
Dialysate flow fixed at 400mL/min for one month.
Dialysate flow at 500mL/minOther
Dialysate flow fixed at 500mL/min for one month.
| Study group | Role | What they receive |
|---|---|---|
| Dialysate flow at 400mL/min | Experimental | Not described Receives: Other: Dialysate flow at 400mL/min |
| Dialysate flow at 500mL/min | Active comparator | Not described Receives: Other: Dialysate flow at 500mL/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesure of Urea Kt/V
Mesure of Urea clearance by two blood samples, after dialysis minus before dialyse (of urea blood sample), at Day 0 and Month 1
Measured: Day 0, Month 1
Secondary outcomes (9)
Mesure of Beta2-microglobulin clearance
Mesure of Beta2-microglobulin clearance by two blood samples, after dialysis minus before dialyse (of urea blood sample), at Day 0 and Month 1
Measured: Day 0, Month 1
Potassium rate before dialysis
Mesure of Potassium rate before dialysis (Blood sample), at Day 0 and Month 1
Measured: Day 0, Month 1
Phosphorus rate before dialysis
Mesure of Phosphorus rate before dialysis (Blood sample), at Day 0 and Month 1
Measured: Day 0, Month 1
Bicarbonate rate before dialysis
Mesure of bicarbonate rate before dialysis (Blood sample), at Day 0 and Month 1
Measured: Day 0, Month 1
Acid indol acetic dosage rate
Blood sample before dialysis at Day 0 and Month 1
Measured: Day 0, Month 1 - Only for patient in dialysis in Assistance Publique Hopitaux de Marseille
Questionnaire The 5-level EQ-5D version (EQ-5D-5L)
Questionnaries Quality of life EQ-5D-5L for patients, at Day 0 and Month 1. Scale ranging from 0 to 100, higher scores mean a better outcome.
Measured: Day 0, Month 1
Questionnaire The Kidney Disease Quality of Life 36-item short form survey (KDQoL)
Questionnaries Quality of life for patients KDQoL, at Day 0 and Month 1. Scale ranging from 0 to 100, higher scores mean a better outcome.
Measured: Day 0, Month 1
Indoxyl sulfate dosing rate
Blood sample before dialysis at Day 0 and Month 1
Measured: Day 0, Month 1 - Only for patient in dialysis in Assistance Publique Hopitaux de Marseille
Para cresyl sulfate dosage rate
Blood sample before dialysis at Day 0 and Month 1
Measured: Day 0, Month 1 - Only for patient in dialysis in Assistance Publique Hopitaux de Marseille
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Disease, ChronicStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Collaborators
- Aix Marseille Université
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718568
- Sponsor's protocol ID
- RCAPHM25_0445
- Other IDs
- 2025-A02924-45
- Acronym
- ReDeDia
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study on the Efficacy of Hemodialysis With Dialysate Flow Rates of 400 mL/Min Versus 500 mL/Min in a Population of Patients Undergoing Chronic Hemodialysis. Impact of Reducing the Dialysate Flow Rate in Chronic Hemodialysis on Dialysis Quality and Environmental Impact on Water Consumption
- ClinicalTrials.gov ID
- NCT07718568
- Acronym / sponsor ID
- ReDeDia / RCAPHM25_0445
- Conditions
- Kidney Disease, Chronic
- Keywords
- Efficicency or Quality of Hemodialysis, Green Dialysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Collaborators
- Aix Marseille Université
- Study start
- Jan 2027 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 22 Jul 2026 (actual)
- 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.
In France, 60,000 patients are receiving renal replacement therapy via dialysis in 2022, 90% of whom are on hemodialysis. This technique is based on the principle of exchange across a membrane between the patient's blood and the dialysate. The goal is to purify the patient's blood as effectively as possible by removing all solutes that have accumulated due to kidney failure. The dialysate is produced from municipal water, which is treated through several processes (reverse osmosis, filtration) to produce ultrapure water. Water consumption at the La Conception Hospital center in Marseille, which conducts 37,000 sessions per year (64 hemodialysis stations), is estimated at 120 m³ of water per day, which is discharged into the sewer system after use. In France, this would correspond to an estimated total consumption of nearly one million m³ of drinking water per year. In the context of climate change, which will lead to a reduction in water resources, it is important to rethink all aspects of water consumption. The investigator's reflection is part of a growing awareness of the environmental impact of dialysis within a working group of the Francophone Society of Nephrology, Dialysis, and Transplantation: "Green Dialysis." The quality of clearance depends on blood flow and dialysate flow rate (Qd). The Qd was set at 500 mL/min based on earlier studies that showed this flow rate corresponded to maximum clearance of urea and the main toxic solutes. These studies were conducted at a time when dialysis membranes were less efficient. Today, the investigators use membranes with higher exchange efficiency. Despite this, the investigators have not reevaluated the appropriateness of a Qd of 500 mL/min. The quality criterion in dialysis is a balanced urea Kt/V measurement >1.2 for a 4-hour session (target set at 1.4 with certain "single-pool" dialysis machine measurement techniques). At the ivnestigator's center, the average urea Kt/V is 1.55 in "single-pool" mode. Reducing the Qd could be done without risk to patients, even if it leads to a decrease in urea Kt/V. A Colombian study with 5 years of follow-up demonstrates patient safety with a Qd of 400 mL/min (vs. 500 mL/min), with no difference in mortality or dialysis efficacy. The study population was not representative of chronic dialysis patients; 10% regained renal function, and the final analysis included only 25 of the 71 patients enrolled.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialysate flow at 400mL/min | Experimental | Other: Dialysate flow at 400mL/min |
| Dialysate flow at 500mL/min | Active comparator | Other: Dialysate flow at 500mL/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- No decompensated psychiatric disorder, acute or decompensated somatic condition
- Patients on hemodialysis for more than 3 months
- Dialysis schedule: 3 times per week for 4 hours each session
- Stable vascular access (arteriovenous fistula or tunneled central catheter)
Key exclusion criteria (9 listed)
- Age < 18 years
- Patient on dialysis for < 3 months
- Unstable vascular access
- Blood flow rate < 300 mL/min
- Urine output > 500 mL/day
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 |
|---|---|---|
| Dialysate flow at 400mL/minDialysate flow fixed at 400mL/min for one month. | Other | Dialysate flow at 400mL/min |
| Dialysate flow at 500mL/minDialysate flow fixed at 500mL/min for one month. | Other | Dialysate flow at 500mL/min |
Primary outcome
Mesure of Urea Kt/V
Time frame: Day 0, Month 1
Mesure of Urea clearance by two blood samples, after dialysis minus before dialyse (of urea blood sample), at Day 0 and Month 1
9 secondary outcomes
Mesure of Beta2-microglobulin clearance
Time frame: Day 0, Month 1
Potassium rate before dialysis
Time frame: Day 0, Month 1
Phosphorus rate before dialysis
Time frame: Day 0, Month 1
Bicarbonate rate before dialysis
Time frame: Day 0, Month 1
Acid indol acetic dosage rate
Time frame: Day 0, Month 1 - Only for patient in dialysis in Assistance Publique Hopitaux de Marseille
Questionnaire The 5-level EQ-5D version (EQ-5D-5L)
Time frame: Day 0, Month 1
Questionnaire The Kidney Disease Quality of Life 36-item short form survey (KDQoL)
Time frame: Day 0, Month 1
Indoxyl sulfate dosing rate
Time frame: Day 0, Month 1 - Only for patient in dialysis in Assistance Publique Hopitaux de Marseille
Para cresyl sulfate dosage rate
Time frame: Day 0, Month 1 - Only for patient in dialysis in Assistance Publique Hopitaux de Marseille
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialysate flow at 400mL/min and Dialysate flow at 500mL/min in people with Kidney Disease, Chronic, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain Vial, Dr (0491383569 ext. + 33, Romain.vial@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mesure of Urea Kt/V (time frame: Day 0, Month 1). 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 22 Jul 2026.