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

Chulalongkorn University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Hemodialysis; Kidney Function

Treatments: Drug: Ketosteril

Study type: Interventional

Funder types: Other

Identifiers

NCT05030168

IRB NO.779/62

Details and patient eligibility

About

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

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Placebo

No Intervention group

Description:

Twice weekly hemodialysis program plus regular protein diet (1.0 g/kg/day) every day

Ketosteril

Experimental group

Description:

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

Treatment:

Drug: Ketosteril