INCREmental DIalysis and Diet for a Better Life Experience
Starting soon · Phase 2
Conditions studied: Incremental Haemodialysis
In brief
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.
Key facts
- Study ID
- NCT07699627
- Run by
- Centre Hospitalier le Mans
- People needed
- 70
- Starts
- 2026-09-01
- Expected to finish
- 2030-09-01
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients (aged 18 years or older)
- Able and accepting to give informed consent
- Starting iHD in the Centre Hospitalier Le Mans
You may not qualify if…
- 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
- 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, …)
Where it is running
- Centre Hospitalier Le Mans — Le Mans, France
Full record on ClinicalTrials.gov
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