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

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

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).

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Behavioral: low protein diet plus α-keto acid; Behavioral: very low protein diet plus α-keto acid

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xuemei Li, M.D.& Ph.D.; Phone Number: 8610-65295058; Email: 0605.mei@gmail.com
• Study Contact Backup: Name: Limeng Chen, M.D.& Ph.D.; Phone Number: 8610-65295351; Email: climeng2000@yahoo.com.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Xuemei Li, M.D.& Ph.D.; Phone Number: 8610-65295058; Email: 0605.mei@gmail.com
      • Contact: Limeng Chen, M.D.& Ph.D.; Phone Number: 8610-65295351; Email: climeng2000@yahoo.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: low protein diet; Behavioral: low protein diet 0.6g of proteins per kilo of body weight per day
Experimental: low protein diet plusα-keto acid; 0.6g of proteins per kilo of body weight per day	Behavioral: low protein diet plus α-keto acid; low protein diet plus α-keto acid 0.6g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets
Experimental: very low protein diet plus α-keto acid; 0.3g of proteins per kilo of body weight per day	Behavioral: very low protein diet plus α-keto acid; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Xuemei Li, M.D.& Ph.D., Peking Union Medical College Hospital

Publications and helpful links

General Publications

• Hahn D, Hodson EM, Fouque D. Low protein diets for non-diabetic adults with chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 29;10:CD001892. doi: 10.1002/14651858.CD001892.pub5.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: August 15, 2011
• First Submitted That Met QC Criteria: August 16, 2011
• First Posted (Estimate): August 17, 2011

Study Record Updates

• Last Update Posted (Estimate): August 17, 2011
• Last Update Submitted That Met QC Criteria: August 16, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: ELPD-CKD