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OpenTrials
Completed

NCT Number: NCT03806998

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

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

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital del Salvador

Santiago, Santiago Metropolitan, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketoacids

Dietary Supplement

Provision of 1 Tablet containing 630 mg of ketoacids every 5 kg of body weight during 16 weeks

Placebo

Dietary Supplement

Provision of placebo capsules similar to active supplement

Primary outcomes

  1. Estimated glomerular filtration rate

    Time frame: 16 weeks

    glomerular filtration rate estimated using the CKD-EPI formula for Cystatin-C

  2. Urinary urea nitrogen excretion

    Time frame: 16 weeks

    Measurement of urea nitrogen i na spot urine sample

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

  • Servicio de Salud Metropolitano Oriente

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 16, 2019
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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