Effects of Low Protein Diet Supplemented With Ketoanalogues on Preservation of Kidney Function in Incremental Dialysis

Phase 2

• Conditions: Kidney Function; Hemodialysis
• Interventions: Drug: Ketosteril

• Registration Number: NCT05030168
• Lead Sponsor: Chulalongkorn University

Brief Summary

The investigators hypothesized that combination of incremental hemodialysis and ketoanologues will better preserve residual kidney function and maintenance of nutritional status among the incident ESRD patients during the early initiation of chronic dialysis. This hypothesis has been a new concept of chronic hemodialysis initiation for End stage renal disease (ESRD) patients

Detailed Description

The investigators plan to conduct the first randomized Phase IIA clinical trial to investigate the efficacy of incremental hemodialysis and moderately low protein diet combined with ketoanologues supplementation on preservation of residual kidney function, inflammatory status and nutritional parameters among incident chronic dialysis patients

Study Timeline

• Study First Submitted: 2020-10-12
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-27
• Last Update Submitted: 2021-08-27
• Study First Posted: 2021-09-01
• Last Update Posted: 2021-09-01
• Study Start: 2021-12
• Primary Completion: 2023-12
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age ≥ 18 years at screening
• Stable CKD stage 5 not yet on dialysis with residual kidney function 5-10 ml/min/1.73m2 by CKD-EPI equation
• Urine output ≥ 800 ml/day
• Willing to participate in the study and can provide inform consent

Exclusion Criteria

• Rapid glomerular filtration rate (GFR) progression defined as a decline of eGFR >10 ml/min/1.73m2 by CKD-EPI equation in the prior 6 months before enrollment
• Presence of wasting diseases, cancer cachexia, tuberculosis, AIDS wasting syndrome
• Other active infection/inflammation determined by CRP >10 mg/L
• Severe gastrointestinal problem: persistent nausea/vomiting, dysphagia, chronic diarrhea, severe malabsorption
• Conditions at baseline requiring withdrawal from the study including severe protein energy wasting by SGA and MIS score, prior kidney transplantation with immunosuppressive agents or other serious medical conditions.
• Pregnancy
• Uncontrolled hypercalcemia (persistent serum Ca ≥10.5 mg/dl)
• BMI ≥ 35 kg/m2
• Hypersensitivity to the active substances or to any of the excipients of Ketosteril
• Disturbed amino acid metabolism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketosteril	Ketosteril	Incremental hemodialysis program, starting from once weekly hemodialysis/hemodialysis filtration(HDF) plus low protein diet (0.6 g/kg/day) and ketoanologues 0.12g/kg/day supplementation on non-dialysis days and regular protein diet (1.0-1.2 g/kg/day) on dialysis day

Primary Outcome Measures

Name	Time	Method
residual renal function	12 months	To demonstrate superiority effect of incremental hemodialysis (HD) protocol (initiate with once-weekly hemodialysis) plus ketoanalogues-supplemented low-protein diet during non-dialysis days over the standard HD protocol (initiate with twice weekly hemodialysis) on preservation of residual renal function (renal urea clearance) at 12 months.

Secondary Outcome Measures

Name	Time	Method
structural protein	12 months	To compare muscle mass between the two treatment groups over 12 months.
muscle function	12 months	To compare muscle strength between the two treatment groups over 12 months.
visceral protein	12 months	To compare serum albumin levels between the two treatment groups over 12 months.