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

NCT05030168 | Unknown Phase 2

• 1 other identifier: IRB NO.779/62
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Kidney Function; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• residual renal function

  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.

  12 months

Secondary Outcomes (3)

• visceral protein

  12 months

• structural protein

  12 months

• muscle function

  12 months

Study Arms (2)

Placebo

NO INTERVENTION

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

Ketosteril

EXPERIMENTAL

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

Drug: Ketosteril

Interventions

Ketosteril DRUG

ketoanalogues of essential amino acid

Also known as: incremental hemodialysis, low protein diet

Ketosteril

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

MeSH Terms

Interventions

ketosteril; Diet, Protein-Restricted

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: September 1, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share