Incremental HaemodialysisPhase 2INCREDIBLENCT07699627
INCREmental DIalysis and Diet for a Better Life Experience
A Phase 2 study testing Supplementation by ketosteril in people with Incremental Haemodialysis, run by Centre Hospitalier le Mans at 1 site in France.
Trial summary
Previous studies suggest that the supplementation of essential amino acids and ketaoacids may prolong the duration of the incremental phase of peritoneal dialysis. There is no data on incremental haemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incremental Haemodialysis
- What is being tested?
- Supplementation by ketosteril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 Sep 2030
- Phase
- Phase 2
- 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
- Adult patients (aged 18 years or older)
- Able and accepting to give informed consent
- Starting iHD in the Centre Hospitalier Le Mans
Who cannot join
- Denying informed consent
- Acute kidney injury (AKI)
- Life expectancy of less than 3 months, or kidney transplantation scheduled within 3 months
- Cognitive impairment severe enough to limit understanding and acceptance of the study
- Impossibility to regain kidney function (bilateral nephrectomy, documented irreversible complete destruction of the kidney tissue)
- Patient with genetic disease affecting amino acid metabolism
Show all 12Show fewer
- Hypercalcemia defined as calcemia beyond the upper limit of normality according to the laboratory where the test is performed and persisting for at least one month
- Hypersensitivity to the active substances or to any of the excipients of Ketosteril
- Non-compliance to dialysis prescription
- Previous enrolment in a randomized study using Ketosteril
- Currently enrolled in another interventional clinical trial
- Protected by law (patient under guardianship, minor, prisoner, pregnant or breastfeeding woman, …)
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
Centre Hospitalier Le Mans
Le Mans, 72000
Christelle JADEAU, MD, 02 44 71 07 81 ext. +33, cjadeau@ch-lemans.fr
Massimo TORREGGIANI, MD
About this study
Official title: INCREDIBLE: INCREmental DIalysis and Diet for a Better Life Experience; Clinical Relevance of an "add-on" Ketosteril Supplementation on Incremental Haemodialysis Period in Incident Haemodialysis Patients. An Exploratory Randomized Controlled Trial
Previous studies suggest that the supplementation of essential amino acids and ketaoacids may prolong the duration of the incremental phase of peritoneal dialysis. There is no data on incremental haemodialysis patients. Such data would be highly needed to support the management of haemodialysis patients in the transition phase from "pre-dialysis" to "full dose" dialysis. In this context, investigator proposed a randomized "add on" trial, to evaluate the effect of the addition of Ketosteril to the usual nutritional plan to patients who start haemodialysis in incremental way.
- Conditions
- Incremental Haemodialysis
- Being tested
- Supplementation by ketosteril
- Keywords
- ketosteril, incremental haemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation by ketosterilDrug
1 tablet each 10 kg of ideal Body Weight is dispensed per day
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Current dietary management, without Ketosteril |
| Interventional arm | Experimental | Current dietary management with supplementation by Ketosteril Receives: Drug: Supplementation by ketosteril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of incremental haemodialysis period
Duration in months of the incremental haemodialysis period (defined as less than 3 times per week but excluding the cases in which dialysis frequency is reduced in the context of palliative and end-of life care)
Measured: 24 months
Secondary outcomes (11)
Mortality
Number of patients who have died (patients who discontinue dialysis in the context of an "end of life care project" are considered as deceased at the start of the program of palliative care)
Measured: 24 months
Hospitalization rates
Hospitalization rates (all causes), excluding the hospitalization at dialysis start and hospitalization for end-of-life care.
Measured: 24 months
Combined outcome mortality and hospitalization
Measured: 24 months
Quality of life
Quality of life is assessed by questionnaire WHO QoL (from 26 to 130, the higher the score, the better the quality of life)
Measured: 24 months
Nutritional status
Nutritional status will be assessed by evaluation of body composition by Bioelectrical Impedance Analysis (BIA).
Measured: 24 months
Costs
Costs related to incremental Haemodialysis and Ketosteril, with respect to costs of standard Haemodialysis
Measured: 24 months
Water saving
Savings in terms of water (m^3) will be calculated based on the number of spared hemodialysis sessions compared to a standard schedule three times/week hemodialysis
Measured: 24 months
Perceived diet quality
Perceived diet quality is assessed by questionnaire MDRD (Modification of Diet in Renal Disease, the higher the score, the more satisfied the patient is with their diet)
Measured: 24 months
Energy savings
Savings in terms of energy (kW/h) will be calculated based on the number of spared hemodialysis sessions compared to a standard schedule three times/week hemodialysis
Measured: 24 months
Waste Management
Savings in terms of waste (kg) will be calculated based on the number of spared hemodialysis sessions compared to a standard schedule three times/week hemodialysis
Measured: 24 months
Assessment of Appetite
Appetite is assessed by council on nutrition appetite questionnaire (A CNAQ score of 28 or less indicates a significant risk of weight loss of at least 5% within six months)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incremental HaemodialysisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699627
- Sponsor's protocol ID
- CHM-2025/S08/16
- Other IDs
- 2025-524093-41-00, 2025
- Acronym
- INCREDIBLE
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INCREDIBLE: INCREmental DIalysis and Diet for a Better Life Experience; Clinical Relevance of an "add-on" Ketosteril Supplementation on Incremental Haemodialysis Period in Incident Haemodialysis Patients. An Exploratory Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07699627
- Acronym / sponsor ID
- INCREDIBLE / CHM-2025/S08/16
- Conditions
- Incremental Haemodialysis
- Keywords
- ketosteril, incremental haemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 13 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.
Previous studies suggest that the supplementation of essential amino acids and ketaoacids may prolong the duration of the incremental phase of peritoneal dialysis. There is no data on incremental haemodialysis patients. Such data would be highly needed to support the management of haemodialysis patients in the transition phase from "pre-dialysis" to "full dose" dialysis. In this context, investigator proposed a randomized "add on" trial, to evaluate the effect of the addition of Ketosteril to the usual nutritional plan to patients who start haemodialysis in incremental way.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Current dietary management, without Ketosteril |
| Interventional arm | Experimental | Drug: Supplementation by ketosterilCurrent dietary management with supplementation by Ketosteril |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (aged 18 years or older)
- Able and accepting to give informed consent
- Starting iHD in the Centre Hospitalier Le Mans
Key exclusion criteria (12 listed)
- Denying informed consent
- Acute kidney injury (AKI)
- Life expectancy of less than 3 months, or kidney transplantation scheduled within 3 months
- Cognitive impairment severe enough to limit understanding and acceptance of the study
- Impossibility to regain kidney function (bilateral nephrectomy, documented irreversible complete destruction of the kidney tissue)
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 |
|---|---|---|
| Supplementation by ketosteril1 tablet each 10 kg of ideal Body Weight is dispensed per day | Drug | Interventional arm |
Primary outcome
Duration of incremental haemodialysis period
Time frame: 24 months
Duration in months of the incremental haemodialysis period (defined as less than 3 times per week but excluding the cases in which dialysis frequency is reduced in the context of palliative and end-of life care)
11 secondary outcomes
Mortality
Time frame: 24 months
Hospitalization rates
Time frame: 24 months
Combined outcome mortality and hospitalization
Time frame: 24 months
Quality of life
Time frame: 24 months
Nutritional status
Time frame: 24 months
Costs
Time frame: 24 months
Water saving
Time frame: 24 months
Perceived diet quality
Time frame: 24 months
Energy savings
Time frame: 24 months
Waste Management
Time frame: 24 months
Assessment of Appetite
Time frame: 24 months
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 13 Jul 2026.
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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 Phase 2 study testing Supplementation by ketosteril in people with Incremental Haemodialysis, run by Centre Hospitalier le Mans 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 3 inclusion and 12 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 13 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Christelle JADEAU, MD (0244710781 ext. +33, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of incremental haemodialysis period (time frame: 24 months). 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 13 Jul 2026.