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Ketoanalogue Supplementation for Muscle Protection in CKD 4 and 5 Patients with Moderately Low Protein Diet

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516764-29-00
Acronym
RBHP 2023 ANIORT 2
Enrollment
100
Registered
2025-01-13
Start date
2026-01-05
Completion date
Unknown
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney disease

Brief summary

Muscle mass index measured by DEXA (appendicular lean mass kg/m²) at 12 months. Appendicular muscle mass is the sum of the lean muscle mass of the upper and lower extremities.

Detailed description

Weight and BMI at 3, 6, 12 months, Concentration of albumin, prealbumin and CRP at 3, 6, 9 and 12 months, Serum lipids and glycemia at 12 months, Skin fold and mid arm muscle circumference, Grip strength measured by dynamometry at 12 months, Muscle performance evaluated by walking speed test over 4 meters at 12 months, Serum Calcium and phosphate at 3, 6, 9 and 12 months, Parathormone at 3, 6, 9 and 12 months, 25OH Vitamin D2 + D3 at 12 months, Bone mineral density measured by DEXA at 12 months, Use and dosage of phosphate binders, Time to renal replacement therapy start (or transplantation?), Estimated GFR using 2012 CKD EPI creatinine and cystatin C equation at 12 months, Proteinuria at 12 months

Interventions

DRUGKetosteril Ketoacid film-coated tablets

Sponsors

CHU Gabriel-Montpied
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Muscle mass index measured by DEXA (appendicular lean mass kg/m²) at 12 months. Appendicular muscle mass is the sum of the lean muscle mass of the upper and lower extremities.

Secondary

MeasureTime frame
Weight and BMI at 3, 6, 12 months, Concentration of albumin, prealbumin and CRP at 3, 6, 9 and 12 months, Serum lipids and glycemia at 12 months, Skin fold and mid arm muscle circumference, Grip strength measured by dynamometry at 12 months, Muscle performance evaluated by walking speed test over 4 meters at 12 months, Serum Calcium and phosphate at 3, 6, 9 and 12 months, Parathormone at 3, 6, 9 and 12 months, 25OH Vitamin D2 + D3 at 12 months, Bone mineral density measured by DEXA at 12 months, Use and dosage of phosphate binders, Time to renal replacement therapy start (or transplantation?), Estimated GFR using 2012 CKD EPI creatinine and cystatin C equation at 12 months, Proteinuria at 12 months

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026