Status:
UNKNOWN
Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease (CKD)- ELPD Study
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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 , s...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01418508
Start Date
August 1 2011
End Date
December 1 2014
Last Update
August 17 2011
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730