A Phase 2 interventional study of Supplementation by ketosteril in Incremental Haemodialysis, sponsored by Centre Hospitalier le Mans. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Centre Hospitalier le Mans · Phase 2, Interventional, and Treatment
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.
Centre Hospitalier le Mans is the lead sponsor of 44 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Current dietary management, without Ketosteril
Current dietary management with supplementation by Ketosteril
Drug: Supplementation by ketosteril
1 tablet each 10 kg of ideal Body Weight is dispensed per day
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)
Time frame: 24 months
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)
Time frame: 24 months
Hospitalization rates
Hospitalization rates (all causes), excluding the hospitalization at dialysis start and hospitalization for end-of-life care.
Time frame: 24 months
Combined outcome mortality and hospitalization
Time frame: 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)
Time frame: 24 months
Nutritional status
Nutritional status will be assessed by evaluation of body composition by Bioelectrical Impedance Analysis (BIA).
Time frame: 24 months
Costs
Costs related to incremental Haemodialysis and Ketosteril, with respect to costs of standard Haemodialysis
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 24 months
Start is estimated for Sep 2026; primary completion for Sep 2030, 48 months later.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier le Mans