Renal Protective Effects of Restricted Protein Dietary With α-keto Acid in CAPD Patients

Study Overview
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Brief Summary
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The prospective, double blind randomized, parallel control, and multi-center clinical trial will evaluate the safety and efficacy of α-keto acid with restricted protein diet on protecting residual renal function in continuous ambulatory peritoneal dialysis (CAPD) 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 α-keto acids may slow the loss of RRF in chronic kidney disease patients. However, these trials are small sample and short-time research. In PD patients, there is very few reports to indicate the effect of α-keto acid with restricted protein diet on RRF. The aim of this study is to evaluate the safety and efficacy of α-keto acid with restricted protein diet on protecting residual renal function in continuous ambulatory peritoneal dialysis (CAPD) patients.This is a prospective, double blind randomized, parallel control, and multi-center clinical study. 160 patients who meet Inclusion/Exclusion criteria will be randomized into α-Keto Acid group or control group at the ratio of 1:1. The α-Keto Acid group will use compound α-Keto Acid plus restricted protein diet, while control group will use placebo plus restricted protein diet.The α-Keto Acid dosage is 100mg/kg/d daily. The restricted protein dosage is 1g/kg/d. The safety and efficacy of α-Keto Acid with restricted protein diet on RRF will be evaluated after 1 year treatment.

Official Title
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Safety and Efficacy Evaluation of Restricted Protein Dietary Supplemented With α-keto Acid on Protecting Residual Renal Function in CAPD Patients--A Prospective, Double Blind Randomized, Parallel Control, Multi-center Clinical Trial

Conditions
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Renal Function Disorder

Intervention / Treatment
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* Drug: α-Keto Acid with restricted protein diet
* Drug: Placebo plus restricted protein diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients on peritoneal dialysis (PD) at least three month prior to study entry. Subjects of either sex, more than 18 years old, the range of age is 18 to 70 year old. Residual GFR ≥ 3 ml/min/1.73m2. Without α-Keto Acid therapy in recent 4 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. Patients with insufficient dialysis. History of taking drug which may influence amino acid metabolism within one month(glucocorticoid, thyroxin, antithyroid drug, androgens,amino acids,et al). Patients with diseases which contraindicate ketosteril. Cannot control diet according to protocol. Alcohol abuse or drug abuse. Having malignant tumor. History of psychiatric or neuropathic dysfunction. Cardiac failure, with New York Heart Association (NYHA) grade III-IV or history of severe heart and cerebrovascular disease in recent one month(acute stroke, acute heart failure, Lability angina) Serum albumin < 30g/l. Serum calcium > 2.8mmol/l. Participation in another clinic trial within last three months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: α-Keto Acid plus restricted protein diet<br>Participants randomized to this group will receive 12 months treatment of α-Keto Acid. The dose of α-Keto Acid is 100mg/kg per day and will divided into three times per day, and the α-Keto Acid will be asked to be taken during the meal. In addition, the participants will be asked to restrict the protein intake. The protein intake is restricted as 1g/kg/d. | Drug: α-Keto Acid with restricted protein diet<br>* α-Keto Acid: The daily dose of compound α-Keto Acid is 100mg/kg/d. The total daily dose will be divided into three times a day. Restricted Protein Diet: Diet contain protein 1.0g/kg/d<br>* Other names: Test Group;|
| Placebo Comparator: Placebo plus restricted protein diet<br>All participants will receive 12 months treatment of placebo, at the same time they will be asked to restrict the protein intake.The dose of placebo is 100mg/kg per day, and the protein intake is restricted as 1g/kg/d. | Drug: Placebo plus restricted protein diet<br>* placebo: The daily dose of placebo is 100mg/kg/d. The total daily dose will be divided into three times a day. Diet contain protein 1.0 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) |  | Every 3 months up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peritoneal membrane transport characteristics |  | Every 3 months up to 12 months | 
| Cardiovascular events |  | Every 3 months up to 12 months | 
| Nutritional status |  | Every 3 months up to 12 months | 
| Hospitalization |  | Every 3 months up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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α-Keto Acid, Restricted Protein Diet, Residual Renal Function