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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03806998

Enrollment

147

Registered

2019-01-16

Start date

2015-09-30

Completion date

2018-10-01

Last updated

2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure

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.

Interventions

DIETARY_SUPPLEMENTKetoacids

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

DIETARY_SUPPLEMENTPlacebo

Provision of placebo capsules similar to active supplement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

There will be no masking of the treatment arm for researchers

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026