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NCT Number: NCT07699627

INCREmental DIalysis and Diet for a Better Life Experience

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.

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Key information

Conditions

Incremental Haemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Le Mans

Le Mans, 72000, France

Location contact

Christelle JADEAU, MD

CONTACT

[email protected]

02 44 71 07 81 ext. +33

Massimo TORREGGIANI, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, …)

Treatment and study plan

Supplementation by ketosteril

Drug

1 tablet each 10 kg of ideal Body Weight is dispensed per day

Primary outcomes

  1. 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)

Secondary outcomes

  1. Mortality

    Time frame: 24 months

    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)

  2. Hospitalization rates

    Time frame: 24 months

    Hospitalization rates (all causes), excluding the hospitalization at dialysis start and hospitalization for end-of-life care.

  3. Combined outcome mortality and hospitalization

    Time frame: 24 months

  4. Quality of life

    Time frame: 24 months

    Quality of life is assessed by questionnaire WHO QoL (from 26 to 130, the higher the score, the better the quality of life)

  5. Nutritional status

    Time frame: 24 months

    Nutritional status will be assessed by evaluation of body composition by Bioelectrical Impedance Analysis (BIA).

  6. Costs

    Time frame: 24 months

    Costs related to incremental Haemodialysis and Ketosteril, with respect to costs of standard Haemodialysis

  7. Water saving

    Time frame: 24 months

    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

  8. Perceived diet quality

    Time frame: 24 months

    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)

  9. Energy savings

    Time frame: 24 months

    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

  10. Waste Management

    Time frame: 24 months

    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

  11. Assessment of Appetite

    Time frame: 24 months

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle JADEAU, MD

CONTACT

[email protected]

0244710781 ext. +33

Massimo TORREGGIANI, MD

CONTACT

[email protected]

02 53 04 04 70 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Official study 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

Acronym: INCREDIBLE

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.