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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of a Ketoacid Supplementation on Urinary Urea Nitrogen Excretion in Patients With Stage III to IV Renal Failure

Conditions
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Renal Failure

Intervention / Treatment
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* Dietary Supplement: Ketoacids
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assgned to receive the ketoacid supplement or placebo
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketoacid supplementation<br>Will receive a ketoacid supplement containing 630 mg of ketoacids in a dose of 1 tablet every 5 kg of body weight | Dietary Supplement: Ketoacids<br>* Provision of 1 Tablet containing 630 mg of ketoacids every 5 kg of body weight during 16 weeks<br>|
| Placebo Comparator: Placebo<br>Will receive placebo tablets in a dose of 1 tablet every 5 kg of body weight | Dietary Supplement: Placebo<br>* Provision of placebo capsules similar to active supplement<br>|

What is the study measuring?
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Primary Outcome Measures

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