Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Renal Function in PD Patients

Randomized, Open-Label, Prospective Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Residual Renal Function (RRF) in Peritoneal Dialysis Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00734552

Enrollment

100

Registered

2008-08-14

Start date

2007-10-31

Completion date

2010-05-31

Last updated

2015-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Dialysis

Keywords

Continuous Ambulatory Peritoneal Dialysis, α-Keto Acid, Low Protein Diet, Residual Renal Function

Brief summary

This randomized, open-label, prospective study will evaluate the renal effective effect of compound α-Keto Acid plus low protein diet in PD Patients.

Detailed description

Residual renal function (RRF) is associated with cardiovascular complication, nutritional status, incidence of peritonitis, and quality of life in peritoneal dialysis (PD) patients. Therefore, RRF is an important determinant of mortality and morbidity in PD patients. Previous studies have suggested that dietary protein restriction supplemented with compound keto/amino acids may slow the loss of RRF in chronic kidney disease patients. However, there is very few reports to address the effect of compound keto/amino acid supplementation in RRF in PD patients. The aim of this study is to evaluate the protective effect of compound α-Keto Acid plus low protein diet in RRF in PD Patients.This is a randomized, open-label, prospective study. 100 patients who meet Inclusion/Exclusion criteria will be randomized into α-Keto Acid group or control group at the ratio of 1:1. α-Keto Acid group will use compound α-Keto Acid plus low protein diet, while control group will use normal protein diet.Compound α-Keto Acid dosage is 0.1/kg/d daily. The effect of compound α-Keto Acid plus low protein diet in RRF will be evaluated after 1 year treatment.

Interventions

DIETARY_SUPPLEMENTα-Keto Acid with low protein diet

Compound α-Keto Acid: The daily dose of compound α-Keto Acid is 0.1/kg/d. The total daily dose will be divided into three times a day. Low Protein Diet: Diet contain protein 0.8g/kg/d.

DIETARY_SUPPLEMENTNormal protein diet

Diet contain protein 1.0-1.2 g/kg/d.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Patients on PD at least one month prior to study entry. 2. Subjects of either sex, more than 20 years old, the range of age is 20 to 75 year old. 3. Residual GFR ≥3 ml/min/1.73m2. 4. Residual urine volume ≥ 500 ml/24h. 5. No history of taking α-Keto Acid within 2 weeks. 6. Subjects who agree to participate in the study and sign the informed consent.

Exclusion criteria

1. History of peritonitis or other infection within one month. 2. History of taking drug which may affect amino acid metabolism within one month. 3. Incapable of following study requirements to control diet. 4. With severe cardiovascular disease, chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse. 5. Participation in another clinic trial within one month prior to screening.

Design outcomes

Primary

Measure	Time frame
The longitudinal change in residual glomerular filtration rate (GFR),residual urine volume	Every 3 months

Secondary

Measure	Time frame
Peritoneal membrane transport characteristics,cardiovascular events,nutritional status,hospitalization, peritonitis episodes, any adverse drug effects.	Every 3 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026