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

Hemodialysis Clinical Trial

Official title:

The Effects of Low Protein Diet Supplemented With Ketoanalogues on Preservation of Residual Kidney Function Among Patients Undergoing Incremental Dialysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05030168
• Other study ID #: IRB NO.779/62
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: December 2021
• Est. completion date: March 2024

Study information

• Verified date: August 2021
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis
• Kidney Function

Intervention

Drug:
• Ketosteril
ketoanalogues of essential amino acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	visceral protein	To compare serum albumin levels between the two treatment groups over 12 months.	12 months
Secondary	structural protein	To compare muscle mass between the two treatment groups over 12 months.	12 months
Secondary	muscle function	To compare muscle strength between the two treatment groups over 12 months.	12 months