Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure
Primary Purpose
Renal Failure
Status
Completed
Phase
Phase 3
Locations
Chile
Study Type
Interventional
Intervention
Ketoacids
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure
Eligibility Criteria
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
Sites / Locations
- Hospital del Salvador
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ketoacid supplementation
Placebo
Arm Description
Will receive a ketoacid supplement containing 630 mg of ketoacids in a dose of 1 tablet every 5 kg of body weight
Will receive placebo tablets in a dose of 1 tablet every 5 kg of body weight
Outcomes
Primary Outcome Measures
Estimated glomerular filtration rate
glomerular filtration rate estimated using the CKD-EPI formula for Cystatin-C
Urinary urea nitrogen excretion
Measurement of urea nitrogen i na spot urine sample
Secondary Outcome Measures
Full Information
NCT ID
NCT03806998
First Posted
January 15, 2019
Last Updated
January 15, 2019
Sponsor
University of Chile
Collaborators
Servicio de Salud Metropolitano Oriente
1. Study Identification
Unique Protocol Identification Number
NCT03806998
Brief Title
Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure
Official Title
Effects of a Ketoacid Supplementation on Urinary Urea Nitrogen Excretion in Patients With Stage III to IV Renal Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
Collaborators
Servicio de Salud Metropolitano Oriente
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assgned to receive the ketoacid supplement or placebo
Masking
Participant
Masking Description
There will be no masking of the treatment arm for researchers
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketoacid supplementation
Arm Type
Experimental
Arm Description
Will receive a ketoacid supplement containing 630 mg of ketoacids in a dose of 1 tablet every 5 kg of body weight
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Will receive placebo tablets in a dose of 1 tablet every 5 kg of body weight
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketoacids
Intervention Description
Provision of 1 Tablet containing 630 mg of ketoacids every 5 kg of body weight during 16 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Provision of placebo capsules similar to active supplement
Primary Outcome Measure Information:
Title
Estimated glomerular filtration rate
Description
glomerular filtration rate estimated using the CKD-EPI formula for Cystatin-C
Time Frame
16 weeks
Title
Urinary urea nitrogen excretion
Description
Measurement of urea nitrogen i na spot urine sample
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Bunout, MD
Organizational Affiliation
INTA University of Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital del Salvador
City
Santiago
State/Province
Metropolitana
Country
Chile
12. IPD Sharing Statement
Learn more about this trial
Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure
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