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Ketoanalogue Supplementation for Muscle Protection in chronic kidney disease (stade 4 and 5) Patients with Moderately Low Protein Diet
EU CTIS ID: 2024-516764-29-00
What this study is testing
To determine the effect of Ketoanalogue supplementation on sarcopenia at 12 months in patients with stage 4 or 5 CKD and dietary protein intake between 0.6 and 0.8 g/kg/d
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men or women older than 18 years
- Stage 4 or 5 Chronic Kidney Disease (CKD) (eGFR with CKD-EPI 2009 creatinine equation < 30 mL/min/m2)
- Protein intake 0.6-0.8 g/kg/d (estimated with dietary survey)
- patient with social security cover
- Written informed consent
You likely can't join if
- Hospitalization in the past 3 months
- Patient under a legal protection (curatorship or tutorship)
- Corticosteroids (> 7.5 mg/d), cytotoxic or immunosuppressive drugs
- Severe symptomatic heart (NYHA 3 or 4) or liver failure (Child Pugh B or C)
- Respiratory failure requiring oxygenotherapy
- Ongoing infection, autoimmune disease or cancer
See the full eligibility criteria
- Men or women older than 18 years
- Stage 4 or 5 Chronic Kidney Disease (CKD) (eGFR with CKD-EPI 2009 creatinine equation < 30 mL/min/m2)
- Protein intake 0.6-0.8 g/kg/d (estimated with dietary survey)
- patient with social security cover
- Written informed consent
- Hospitalization in the past 3 months
- Patient under a legal protection (curatorship or tutorship)
- Corticosteroids (> 7.5 mg/d), cytotoxic or immunosuppressive drugs
- Severe symptomatic heart (NYHA 3 or 4) or liver failure (Child Pugh B or C)
- Respiratory failure requiring oxygenotherapy
- Ongoing infection, autoimmune disease or cancer
- Pregnant (e.g., positive human chorionic gonadotrophin [HCG] test) or lactating patients
- Patients with psychiatric or cognitive disorders rendering them unable to give written informed consent
- Hypersensitivity to the active substances in Ketosteril
- Hypercalcaemia
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.