INCREmental DIalysis and Diet for a Better Life Experience (INCREDIBLE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Incremental Haemodialysis
• Intervention / Treatment: Drug: Supplementation by ketosteril

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Christelle JADEAU, MD; Phone Number: +33 0244710781; Email: cjadeau@ch-lemans.fr
• Study Contact Backup: Name: Massimo TORREGGIANI, MD; Phone Number: +33 02 53 04 04 70; Email: mtorreggiani@ch-lemans.fr

Study Locations

• France
  • Le Mans, France, 72000
    • Centre Hospitalier Le Mans
    • Contact: Christelle JADEAU, MD; Phone Number: +33 02 44 71 07 81; Email: cjadeau@ch-lemans.fr
    • Principal Investigator: Massimo TORREGGIANI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, …)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Current dietary management, without Ketosteril
Experimental: Interventional arm; Current dietary management with supplementation by Ketosteril	Drug: Supplementation by ketosteril; 1 tablet each 10 kg of ideal Body Weight is dispensed per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24 months
Hospitalization rates	Hospitalization rates (all causes), excluding the hospitalization at dialysis start and hospitalization for end-of-life care.	24 months
Combined outcome mortality and hospitalization		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)	24 months
Nutritional status	Nutritional status will be assessed by evaluation of body composition by Bioelectrical Impedance Analysis (BIA).	24 months
Costs	Costs related to incremental Haemodialysis and Ketosteril, with respect to costs of standard Haemodialysis	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	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)	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	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	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)	24 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: incremental haemodialysis; ketosteril
• Other Study ID Numbers: CHM-2025/S08/16; 2025-524093-41-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No