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

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03806998
• Other study ID #: Ketosterilrenal
• Status: Completed
• Phase: Phase 3
• Start date: September 2015
• Est. completion date: October 1, 2018

Study information

• Verified date: January 2019
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Dietary Supplement:
• Ketoacids
Provision of 1 Tablet containing 630 mg of ketoacids every 5 kg of body weight during 16 weeks
• Placebo
Provision of placebo capsules similar to active supplement

Locations

Country	Name	City	State
Chile	Hospital del Salvador	Santiago	Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
University of Chile	Servicio de Salud Metropolitano Oriente

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated glomerular filtration rate	glomerular filtration rate estimated using the CKD-EPI formula for Cystatin-C	16 weeks
Primary	Urinary urea nitrogen excretion	Measurement of urea nitrogen i na spot urine sample	16 weeks