Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure

Phase 3

Completed

• Conditions: Renal Failure
• Interventions: Dietary Supplement: Ketoacids; Dietary Supplement: Placebo

• Registration Number: NCT03806998
• Lead Sponsor: University of Chile

Brief Summary

The aim of the study is to demonstrate that a ketoacid supplement in patients with stage III to IV chronic renal failure, reduces the excretion of urinary urea nitrogen

Detailed Description

Patients with an estimated glomerular filtration rate of less than 25 ml/kg/min, not on renal substitution therapy, without important concomitant diseases and aged between 40 and 70 years, will be invited to participate in the study. They will be randomly assigned to a group that will receive receive a supplement of ketoacids (Ketosteril) 1 tablet containing 630 mg of ketoacids every 5 kg of body weight and a diet containing 25 to 35 kcal/kg and 0.3 g/protein per day or to a group receiving placebo and a diet containing 25 to 35 kcal/kg and 0.6 g/protein per day. The intervention will last 16 weeks. At baseline and the end of the intervention a blood sample will be obtained to measure creatinine, urea nitrogen and cystatin C. Also a spot urine sample will be obtained to measure urea nitrogen and creatinine excretion. The compliance with the dietary prescription and the ketoacid or placebo supplement will be assessed every 2 weeks.

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-01
• Status Verified: 2019-01
• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-15
• Last Update Submitted: 2019-01-15
• Study First Posted: 2019-01-16
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• Estimated glomerular filtration rate of less tan 25/ml/min/1.73m2
• Not on renal substitution therapy
• Absence of severe life threatening concomitant diseases

Exclusion Criteria

• Malignant or renovascular hypertension
• Use of systemic steroids or immunosuppressant drugs
• Alcohol or illicit drug abuse
• A body mass index of less tan 18 kg/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketoacid supplementation	Ketoacids	Will receive a ketoacid supplement containing 630 mg of ketoacids in a dose of 1 tablet every 5 kg of body weight
Placebo	Placebo	Will receive placebo tablets in a dose of 1 tablet every 5 kg of body weight

Primary Outcome Measures

Name	Time	Method
Estimated glomerular filtration rate	16 weeks	glomerular filtration rate estimated using the CKD-EPI formula for Cystatin-C
Urinary urea nitrogen excretion	16 weeks	Measurement of urea nitrogen i na spot urine sample

Trial Locations

Locations (1)

Hospital del Salvador; 🇨🇱 Santiago, Metropolitana, Chile