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New treatment option for Kidney Disease, Chronic
Official title Ketoanalogue Supplementation for Muscle Protection in CKD 4 and 5 Patients With Moderately Low Protein Diet (KETO-PROT-ACTION)
ClinicalTrials.gov ID: NCT07374042
What this study is testing
What is Keto Acid?
Keto Acid is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for kidney disease, chronic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Chronic kidney disease (CKD) complicates many pathologies and the rapid increase in its prevalence constitutes a major public health concern. Whatever the cause of kidney failure, high protein consumption is a factor of progression to end-stage kidney disease.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Men or women
- Older than 18 years of age
- Stage 4 or 5 CKD (eGFR with CKD-EPI 2009 creatinine equation \< 30 mL/min/m2), whitout renal replacement therapy or kidney transplantation
- Protein intake 0.6-0.8 g/kg/d (estimated with Moroni formula)
- Social security cover
You likely can't join if
- Hospitalization in the past 3 months
- 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
See the full eligibility criteria
- Men or women
- Older than 18 years of age
- Stage 4 or 5 CKD (eGFR with CKD-EPI 2009 creatinine equation \< 30 mL/min/m2), whitout renal replacement therapy or kidney transplantation
- Protein intake 0.6-0.8 g/kg/d (estimated with Moroni formula)
- Social security cover
- Written informed consent
- Hospitalization in the past 3 months
- 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
- Risk of pregnancy: any woman who does not fulfil one of the following criteria:
- post-menopausal (aged \> 45 years with amenorrhea for more than 2 years, or of any age with amenorrhea for more than 6 months and an FSH level \> 40 mUI / mL)
- permanent sterilisation (e.g., occlusion/bilateral ligature of the fallopian tubes, hysterectomy, bilateral salpingectomy, bilateral ovariectomy) or constitutional sterility
- of childbearing age and using an efficient method of contraception, begun at least 28 days before inclusion. Efficient contraception methods are: oral, injectable or implantable hormonal methods intra-uterine devices...
- Patients with psychiatric or cognitive disorders rendering them unable to give written informed consent
- Patients unwilling to participate in the study
- Hypersensitivity to the active substances in Ketosteril®
- Hypercalcaemia
- Hypophosphatemia
- Patient under a legal protection (curatorship or tutorship)
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
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 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.