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

NCT ID: NCT05030168

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2024-03-31

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

Conditions

Kidney Function; Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Placebo

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Ketosteril

Intervention Type: DRUG

ketoanalogues of essential amino acid

Interventions

Ketosteril

ketoanalogues of essential amino acid

Intervention Type: DRUG

Other Intervention Names

incremental hemodialysis; low protein diet

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Kearkiat Praditpornsilpa

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IRB NO.779/62

Identifier Type: -

Identifier Source: org_study_id