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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
EU CTIS ID: 2025-524093-41-00
What this study is testing
To evaluate the efficacy of the addition of Ketosteril to the usual nutritional plan to patients who start incremental haemodialysis with respect to the end-point duration of the incremental haemodialysis period
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients (aged 18 years or older)
- Able and accepting to give informed consent
- Starting incremental Haemodialysis in the Centre Hospitalier Le Mans
You likely can't join if
- Denying informed consent
- 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, …)
- Acute kidney injury (AKI)
- Life expectancy of less than 3 months, or kidney transplantation scheduled within 3 months
See the full eligibility criteria
- Adult patients (aged 18 years or older)
- Able and accepting to give informed consent
- Starting incremental Haemodialysis in the Centre Hospitalier Le Mans
- Denying informed consent
- 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, …)
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.