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

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Le Mans

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Decision date (initial)

2026-05-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

FRESENIUS KABI DEUTSCHLAND GmbH

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate the efficacy of the addition of Ketosteril to the usual nutritional plan to patients who start incremental haemodialysis with respect to the end-point duration of the incremental haemodialysis period

Secondary objectives 1

1. To evaluate the effects of the addition of Ketosteril on the nutritional status, the compliance, quality of life, hospitalizations, survival, metabolic balance, sustainability and costs of patients who start haemodialysis

Conditions and MedDRA coding

Incremental Haemodialysis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Adult patients (aged 18 years or older)
2. Able and accepting to give informed consent
3. Starting incremental Haemodialysis in the Centre Hospitalier Le Mans

Exclusion criteria 12

1. Denying informed consent
2. Acute kidney injury (AKI)
3. Life expectancy of less than 3 months, or kidney transplantation scheduled within 3 months
4. Cognitive impairment severe enough to limit understanding and acceptance of the study
5. Impossibility to regain kidney function (bilateral nephrectomy, documented irreversible complete destruction of the kidney tissue)
6. Patient with genetic disease affecting amino acid metabolism
7. 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
8. Hypersensitivity to the active substances or to any of the excipients of Ketosteril
9. Non-compliance to dialysis prescription
10. Previous enrolment in a randomized study using Ketosteril
11. Currently enrolled in another interventional clinical trial
12. Protected by law (patient under guardianship, minor, prisoner, pregnant or breastfeeding woman, …)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 7

1. Mortality (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 (all causes), excluding the hospitalization at dialysis start and hospitalization for end-of-life care
3. Combined outcome mortality and hospitalization
4. Quality of life (WHO QoL), and perceived diet quality (MDRD diet quality questionnaire); Council on Nutrition Appetite Questionnaire (CNAQ) are performed at start of treatment and every 3 months
5. Nutritional status, according to the main usual biochemical and clinical markers (albumin, hemoglobin, CRP, pre-albumin levels; need for ESAs; weigh, BMI; body composition (bioimpedance); handgrip strength measurement), SGA, MIS, in keeping with the recommendations of the KDOQI guidelines 2020
6. Costs related to incremental Haemodialysis and Ketosteril, with respect to costs of standard Haemodialysis
7. Sustainability (savings in terms of water, energy, wastes, related to the reduction of the dialysis sessions)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Le Mans

Sponsor organisation

Centre Hospitalier Le Mans

Address

194 Avenue Rubillard

City

Le Mans Cedex 9

Postcode

72037

Country

France

Scientific contact point

Organisation

Centre Hospitalier Le Mans

Contact name

Clinical research project manager

Public contact point

Organisation

Centre Hospitalier Le Mans

Contact name

Clinical research project manager

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications