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

NCT03806998 | Completed Phase 3 DMC

• 1 other identifier: Ketosterilrenal
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Ketoacid supplementation

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Will receive placebo tablets in a dose of 1 tablet every 5 kg of body weight

Dietary Supplement: Placebo

Interventions

Ketoacids DIETARY_SUPPLEMENT

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

Ketoacid supplementation

Placebo DIETARY_SUPPLEMENT

Provision of placebo capsules similar to active supplement

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead
• Servicio de Salud Metropolitano Oriente: collaborator

Study Sites (1)

Hospital del Salvador

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Keto Acids

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals

Study Officials

• Daniel Bunout, MD

  INTA University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: There will be no masking of the treatment arm for researchers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Cardiovascular Program

Model Details: Participants will be randomly assgned to receive the ketoacid supplement or placebo

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 16, 2019
• Study Start: September 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

CL (1)