Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease (CKD)- ELPD Study

Study Overview
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Brief Summary
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The purpose of this study is to determine whether low protein diet and very low protein diet supplemented keto-/amino acid is effective in preventing the progression of chronic kidney disease (CKD , stage 3b and 4).

Detailed Description
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Dietary protein restriction represents a basic therapeutic approach in chronic kidney disease(CKD), by reducing the accumulation of nitrogen catabolic substances, and by delaying the progress of CKD and proteinuria, but the effects of the different degree's protein diet on the renal progression remain to be determined. The aim of this study is to evaluate the efficacy of low protein diet and α-keto acid tablet in retard the progress of CKD. This is a randomized, open-label, prospective study, 120 patients who meet inclusion and exclusion criteria will be randomized into three groups at the ratio of 1:1:1. Group I patients will receive low protein diet(0.6g/kg BW), group II will receive low protein diet supplemented with α-keto acid, while group III will take very low protein diet(0.3g/kg BW) supplemented with α-keto acid. The changes of glomerular filtration rate in CKD will be evaluated after 1 year treatment.

Official Title
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Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease(CKD)- ELPD Study

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Behavioral: low protein diet plus α-keto acid
* Behavioral: very low protein diet plus α-keto acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic kidney disease in stage 3b and 4(15ml/min/1.73m2<GFR<45 ml/min/1.73m2, estimated by EPI formula) receiving conservative treatment for CKD Exclusion Criteria: With diagnosis of diabetic mellitus; Incapable of following study requirements to control diet; Glomerular filtration rate < 15 ml/min/1.73m2; Hypercalcemia or hyperkalemia (> normal upper limit); Other serious disease(eg.heart,lung,brain) within the last 3 months; Cardiac failure stage IV NYHA; With cirrhosis of liver or obvious symptoms of liver diseases, ALT or AST two times normal upper limit; Severe edema or serous cavity effusion; Drug abuse; Final diagnosis of malignant tumor; Receiving the long-term systematic steroid hormone or immunosuppressive agents(eg. Cyclophosphamidum,Cyclosporine, Prograf,Azathioprine) treatment; Gestation already, prepares to be pregnant in the period of the trial, lactating women; Participate in other product clinical trial within 30 days prior to this trial

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| No Intervention: low protein diet<br>Behavioral: low protein diet 0.6g of proteins per kilo of body weight per day | |
| Experimental: low protein diet plusα-keto acid<br>0.6g of proteins per kilo of body weight per day | Behavioral: low protein diet plus α-keto acid<br>* low protein diet plus α-keto acid 0.6g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets<br>|
| Experimental: very low protein diet plus α-keto acid<br>0.3g of proteins per kilo of body weight per day | Behavioral: very low protein diet plus α-keto acid<br>* very low protein diet plus α-keto acid 0.3g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in glomerular filtration rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to diet |  | 1 year | 
| Quality of life |  | 1 year | 
| Cardiovascular morbidity | Cardiovascular morbidity, defined by angina, heart failure, myocardial infarction, left ventricular mass, stroke, blood pressure, lipid profile, calcium/phosphorus/parathormone status and Charlson comorbidity index, at the start of dialysis | 1 year | 
| Nutritional status | Nutritional status, defined by anthropo-plicometry, biochemistry, body bioimpedance analysis (BIA), subjective global nutritional assessment (SGA), at the start and during the 1st year of dialysis | 1 year |