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

This study is currently recruiting participants.

Verified August 2011 by Peking Union Medical College Hospital

Sponsor:

Information provided by:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT01418508

First received: August 15, 2011

Last updated: August 16, 2011

Last verified: August 2011

History of Changes

Purpose

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).

Condition	Intervention
Chronic Kidney Disease	Behavioral: low protein diet plus α-keto acid Behavioral: very low protein diet plus α-keto acid

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease(CKD)- ELPD Study

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease

Drug Information available for: Amino acids

U.S. FDA Resources

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:

changes in glomerular filtration rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Compliance to diet [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Cardiovascular morbidity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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

Estimated Enrollment:	120
Study Start Date:	August 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418508

Contacts

Contact: Xuemei Li, M.D.& Ph.D.	8610-65295058	0605.mei@gmail.com
Contact: Limeng Chen, M.D.& Ph.D.	8610-65295351	climeng2000@yahoo.com.cn

Locations

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

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

Principal Investigator:

Xuemei Li, M.D.& Ph.D.

Peking Union Medical College Hospital

More Information

No publications provided

Responsible Party:	Xuemei Li, department of nephrology
ClinicalTrials.gov Identifier:	NCT01418508 History of Changes
Other Study ID Numbers:	ELPD-CKD
Study First Received:	August 15, 2011
Last Updated:	August 16, 2011
Health Authority:	China: Ministry of Health

Additional relevant MeSH terms:

Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 22, 2013

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