INCREmental DIalysis and Diet for a Better Life Experience
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Supplementation by ketosteril.
- Who it may be relevant to
- Registry conditions: Incremental Haemodialysis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Supplementation by ketosteril
1 tablet each 10 kg of ideal Body Weight is dispensed per day
Primary outcome measures
- Duration of incremental haemodialysis period [Time frame: 24 months]
Secondary outcome measures (11)
- 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]
Eligibility criteria
Inclusion criteria
- Adult patients (aged 18 years or older)
- Able and accepting to give informed consent
- Starting iHD in the Centre Hospitalier Le Mans
Exclusion criteria
- 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, …)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Centre Hospitalier Le Mans — Le Mans
Identifiers
NCT: NCT07699627 · CHM-2025/S08/16 · 2025-524093-41-00