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

NCT ID: NCT03806998

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-10-01

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.

Conditions

Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ketoacid supplementation

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

Group Type: EXPERIMENTAL

Ketoacids

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Provision of placebo capsules similar to active supplement

Interventions

Ketoacids

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Provision of placebo capsules similar to active supplement

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Servicio de Salud Metropolitano Oriente

UNKNOWN

Sponsor Role: collaborator

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Lorca

Chief Cardiovascular Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Bunout, MD

Role: PRINCIPAL_INVESTIGATOR

INTA University of Chile

Locations

Hospital del Salvador

Santiago, Santiago Metropolitan, Chile

Countries

Chile

Other Identifiers

Ketosterilrenal

Identifier Type: -

Identifier Source: org_study_id