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

January 15, 2019 updated by: Eduardo Lorca, University of Chile

Effects of a Ketoacid Supplementation on Urinary Urea Nitrogen Excretion 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • Hospital del Salvador

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ketoacid supplementation
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
Provision of 1 Tablet containing 630 mg of ketoacids every 5 kg of body weight during 16 weeks
PLACEBO_COMPARATOR: Placebo
Will receive placebo tablets in a dose of 1 tablet every 5 kg of body weight
Dietary supplement: Placebo
Provision of placebo capsules similar to active supplement

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Collaborators

Servicio de Salud Metropolitano Oriente

Investigators

  • Principal Investigator: Daniel Bunout, MD, INTA University of Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ACTUAL)

October 1, 2018

Study Completion (ACTUAL)

October 1, 2018

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (ACTUAL)

January 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ketosterilrenal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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