Chronic Kidney DiseaseELPD-CKDNCT01418508
Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease (CKD)- ELPD Study
A study testing low protein diet plus α-keto acid and very low protein diet plus α-keto acid in people with Chronic Kidney Disease, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- low protein diet plus α-keto acid and very low protein diet plus α-keto acid
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xuemei Li, M.D.& Ph.D., 8610-65295058, 0605.mei@gmail.com
Limeng Chen, M.D.& Ph.D., 8610-65295351, climeng2000@yahoo.com.cn
About this study
Official title: 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).
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- low protein diet plus α-keto acid, very low protein diet plus α-keto acid
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low protein diet plus α-keto acidBehavioural
low protein diet plus α-keto acid 0.6g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets
very low protein diet plus α-keto acidBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| low protein diet | No intervention | Behavioral: low protein diet 0.6g of proteins per kilo of body weight per day |
| low protein diet plusα-keto acid | Experimental | 0.6g of proteins per kilo of body weight per day Receives: Behavioral: low protein diet plus α-keto acid |
| very low protein diet plus α-keto acid | Experimental | 0.3g of proteins per kilo of body weight per day Receives: Behavioral: very low protein diet plus α-keto acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in glomerular filtration rate
Measured: 1 year
Secondary outcomes (4)
Compliance to diet
Measured: 1 year
Quality of life
Measured: 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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Xuemei Li, M.D.& Ph.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418508
- Sponsor's protocol ID
- ELPD-CKD
- Acronym
- ELPD-CKD
- Status last verified
- Aug 2011
- First submitted
- 15 Aug 2011
- Last updated
- 17 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
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(10):CD001892. doi: 10.1002/14651858.CD001892.pub5.
PubMed 33118160
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease(CKD)- ELPD Study
- ClinicalTrials.gov ID
- NCT01418508
- Acronym / sponsor ID
- ELPD-CKD / ELPD-CKD
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low protein diet | No intervention | –Behavioral: low protein diet 0.6g of proteins per kilo of body weight per day |
| low protein diet plusα-keto acid | Experimental | Behavioral: low protein diet plus α-keto acid0.6g of proteins per kilo of body weight per day |
| very low protein diet plus α-keto acid | Experimental | Behavioral: very low protein diet plus α-keto acid0.3g of proteins per kilo of body weight per day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low protein diet plus α-keto acidlow protein diet plus α-keto acid 0.6g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets | Behavioural | low protein diet plusα-keto acid |
| very low protein diet plus α-keto acidvery low protein diet plus α-keto acid 0.3g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets | Behavioural | very low protein diet plus α-keto acid |
Primary outcome
changes in glomerular filtration rate
Time frame: 1 year
4 secondary outcomes
Compliance to diet
Time frame: 1 year
Quality of life
Time frame: 1 year
Cardiovascular morbidity
Time frame: 1 year
Nutritional status
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2011.
- Derived from this study: PubMed 33118160Hahn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuemei Li, M.D.& Ph.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low protein diet plus α-keto acid and very low protein diet plus α-keto acid in people with Chronic Kidney Disease, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuemei Li, M.D.& Ph.D. (8610-65295058, 0605.mei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in glomerular filtration rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01418508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2011.