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

Primary Purpose

Chronic Kidney Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
low protein diet plus α-keto acid
very low protein diet plus α-keto acid
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

low protein diet

low protein diet plusα-keto acid

very low protein diet plus α-keto acid

Arm Description

Behavioral: low protein diet 0.6g of proteins per kilo of body weight per day

0.6g of proteins per kilo of body weight per day

0.3g of proteins per kilo of body weight per day

Outcomes

Primary Outcome Measures

changes in glomerular filtration rate

Secondary Outcome Measures

Compliance to diet
Quality of life
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
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

Full Information

First Posted
August 15, 2011
Last Updated
August 16, 2011
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01418508
Brief Title
Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease (CKD)- ELPD Study
Acronym
ELPD-CKD
Official Title
Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease(CKD)- ELPD Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low protein diet
Arm Type
No Intervention
Arm Description
Behavioral: low protein diet 0.6g of proteins per kilo of body weight per day
Arm Title
low protein diet plusα-keto acid
Arm Type
Experimental
Arm Description
0.6g of proteins per kilo of body weight per day
Arm Title
very low protein diet plus α-keto acid
Arm Type
Experimental
Arm Description
0.3g of proteins per kilo of body weight per day
Intervention Type
Behavioral
Intervention Name(s)
low protein diet plus α-keto acid
Intervention Description
low protein diet plus α-keto acid 0.6g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets
Intervention Type
Behavioral
Intervention Name(s)
very low protein diet plus α-keto acid
Intervention Description
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
Primary Outcome Measure Information:
Title
changes in glomerular filtration rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Compliance to diet
Time Frame
1 year
Title
Quality of life
Time Frame
1 year
Title
Cardiovascular morbidity
Description
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
Time Frame
1 year
Title
Nutritional status
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuemei Li, M.D.& Ph.D.
Phone
8610-65295058
Email
0605.mei@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Limeng Chen, M.D.& Ph.D.
Phone
8610-65295351
Email
climeng2000@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuemei Li, M.D.& Ph.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuemei Li, M.D.& Ph.D.
Phone
8610-65295058
Email
0605.mei@gmail.com
First Name & Middle Initial & Last Name & Degree
Limeng Chen, M.D.& Ph.D.
Phone
8610-65295351
Email
climeng2000@yahoo.com.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
33118160
Citation
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(10):CD001892. doi: 10.1002/14651858.CD001892.pub5.
Results Reference
derived

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

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