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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Peritoneal Dialysis

Intervention / Treatment
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* Dietary Supplement: α-Keto Acid with low protein diet
* Dietary Supplement: Normal protein diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients on PD at least one month prior to study entry. Subjects of either sex, more than 20 years old, the range of age is 20 to 75 year old. Residual GFR ≥3 ml/min/1.73m2. Residual urine volume ≥ 500 ml/24h. No history of taking α-Keto Acid within 2 weeks. Subjects who agree to participate in the study and sign the informed consent. Exclusion Criteria: History of peritonitis or other infection within one month. History of taking drug which may affect amino acid metabolism within one month. Incapable of following study requirements to control diet. With severe cardiovascular disease, chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse. Participation in another clinic trial within one month prior to screening.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>α-Keto Acid plus low protein diet | Dietary Supplement: α-Keto Acid with low protein diet<br>* 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.<br>* Other names: Test Group;|
| Other: 2<br>Normal protein diet | Dietary Supplement: Normal protein diet<br>* Diet contain protein 1.0-1.2 g/kg/d.<br>* Other names: Control Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The longitudinal change in residual glomerular filtration rate (GFR),residual urine volume |  | Every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peritoneal membrane transport characteristics,cardiovascular events,nutritional status,hospitalization, peritonitis episodes, any adverse drug effects. |  | Every 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Ambulatory Peritoneal Dialysis, α-Keto Acid, Low Protein Diet, Residual Renal Function