INCREmental DIalysis and Diet for a Better Life Experience (INCREDIBLE)
8. juli 2026 opdateret af: Centre Hospitalier le Mans
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
70
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Christelle JADEAU, MD
- Telefonnummer: +33 0244710781
- E-mail: cjadeau@ch-lemans.fr
Undersøgelse Kontakt Backup
- Navn: Massimo TORREGGIANI, MD
- Telefonnummer: +33 02 53 04 04 70
- E-mail: mtorreggiani@ch-lemans.fr
Studiesteder
-
-
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Le Mans, Frankrig, 72000
- Centre Hospitalier Le Mans
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Kontakt:
- Christelle JADEAU, MD
- Telefonnummer: +33 02 44 71 07 81
- E-mail: cjadeau@ch-lemans.fr
-
Ledende efterforsker:
- Massimo TORREGGIANI, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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, …)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Control arm
Current dietary management, without Ketosteril
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|
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Eksperimentel: Interventional arm
Current dietary management with supplementation by Ketosteril
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1 tablet each 10 kg of ideal Body Weight is dispensed per day
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Duration of incremental haemodialysis period
Tidsramme: 24 months
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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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mortality
Tidsramme: 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)
|
24 months
|
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Hospitalization rates
Tidsramme: 24 months
|
Hospitalization rates (all causes), excluding the hospitalization at dialysis start and hospitalization for end-of-life care.
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24 months
|
|
Combined outcome mortality and hospitalization
Tidsramme: 24 months
|
24 months
|
|
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Quality of life
Tidsramme: 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)
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24 months
|
|
Nutritional status
Tidsramme: 24 months
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Nutritional status will be assessed by evaluation of body composition by Bioelectrical Impedance Analysis (BIA).
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24 months
|
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Costs
Tidsramme: 24 months
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Costs related to incremental Haemodialysis and Ketosteril, with respect to costs of standard Haemodialysis
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24 months
|
|
Water saving
Tidsramme: 24 months
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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
Tidsramme: 24 months
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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)
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24 months
|
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Energy savings
Tidsramme: 24 months
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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
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24 months
|
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Waste Management
Tidsramme: 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
|
24 months
|
|
Assessment of Appetite
Tidsramme: 24 months
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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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. september 2030
Studieafslutning (Anslået)
1. september 2030
Datoer for studieregistrering
Først indsendt
9. juni 2026
Først indsendt, der opfyldte QC-kriterier
8. juli 2026
Først opslået (Faktiske)
13. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- CHM-2025/S08/16
- 2025-524093-41-00 (Ctis)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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