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

University of Chile

Status and phase: Completed; Phase 3

Conditions: Renal Failure

Treatments: Dietary Supplement: Ketoacids; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03806998

Ketosterilrenal

Details and patient eligibility

About

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

Full 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.

Enrollment: 147 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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147 participants in 2 patient groups, including a placebo group

Ketoacid supplementation

Experimental group

Description:

Will receive a ketoacid supplement containing 630 mg of ketoacids in a dose of 1 tablet every 5 kg of body weight

Treatment:

Dietary Supplement: Ketoacids

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo