Peritoneal DialysisNCT00734552
Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Renal Function in PD Patients
A study testing α-Keto Acid with low protein diet and Normal protein diet in people with Peritoneal Dialysis, run by Sun Yat-sen University at 1 site in China.
Trial summary
This randomized, open-label, prospective study will evaluate the renal effective effect of compound α-Keto Acid plus low protein diet in PD Patients. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Peritoneal Dialysis
- What is being tested?
- α-Keto Acid with low protein diet and Normal protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2007to May 2010
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on PD at least one month prior to study entry.
- Subjects of either sex, more than 20 years old, the range of age is 20 to 75 year old.
- Residual GFR ≥3 ml/min/1.73m2.
- Residual urine volume ≥ 500 ml/24h.
- No history of taking α-Keto Acid within 2 weeks.
- Subjects who agree to participate in the study and sign the informed consent.
Who cannot join
- History of peritonitis or other infection within one month.
- History of taking drug which may affect amino acid metabolism within one month.
- Incapable of following study requirements to control diet.
- With severe cardiovascular disease, chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse.
- Participation in another clinic trial within one month prior to screening.
Trial locations and contacts
1 site in 1 country.
China1 site
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Randomized, Open-Label, Prospective Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Residual Renal Function (RRF) in Peritoneal Dialysis Patients
This randomized, open-label, prospective study will evaluate the renal effective effect of compound α-Keto Acid plus low protein diet in PD Patients.
Read the detailed description
Residual renal function (RRF) is associated with cardiovascular complication, nutritional status, incidence of peritonitis, and quality of life in peritoneal dialysis (PD) patients. Therefore, RRF is an important determinant of mortality and morbidity in PD patients.
Previous studies have suggested that dietary protein restriction supplemented with compound keto/amino acids may slow the loss of RRF in chronic kidney disease patients. However, there is very few reports to address the effect of compound keto/amino acid supplementation in RRF in PD patients.
The aim of this study is to evaluate the protective effect of compound α-Keto Acid plus low protein diet in RRF in PD Patients.This is a randomized, open-label, prospective study. 100 patients who meet Inclusion/Exclusion criteria will be randomized into α-Keto Acid group or control group at the ratio of 1:1. α-Keto Acid group will use compound α-Keto Acid plus low protein diet, while control group will use normal protein diet.Compound α-Keto Acid dosage is 0.1/kg/d daily. The effect of compound α-Keto Acid plus low protein diet in RRF will be evaluated after 1 year treatment.
- Conditions
- Peritoneal Dialysis
- Being tested
- α-Keto Acid with low protein diet, Normal protein diet
- Keywords
- Continuous Ambulatory Peritoneal Dialysis, α-Keto Acid, Low Protein Diet, Residual Renal Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
α-Keto Acid with low protein dietDietary supplement
Also called Test Group
Compound α-Keto Acid: The daily dose of compound α-Keto Acid is 0.1/kg/d. The total daily dose will be divided into three times a day.
Low Protein Diet: Diet contain protein 0.8g/kg/d.
Normal protein dietDietary supplement
Also called Control Group
Diet contain protein 1.0-1.2 g/kg/d.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | α-Keto Acid plus low protein diet Receives: Dietary Supplement: α-Keto Acid with low protein diet |
| 2 | Other | Normal protein diet Receives: Dietary Supplement: Normal protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The longitudinal change in residual glomerular filtration rate (GFR),residual urine volume
Measured: Every 3 months
Secondary outcomes (1)
Peritoneal membrane transport characteristics,cardiovascular events,nutritional status,hospitalization, peritonitis episodes, any adverse drug effects.
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Qing Yu, Sun Yat-sen University
- Investigators
- Xueqing Yu, M.D. & Ph.D., Principal investigator, 1st Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734552
- Sponsor's protocol ID
- SYSU-KAPDRRF
- Status last verified
- May 2015
- First submitted
- 13 Aug 2008
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Label, Prospective Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Residual Renal Function (RRF) in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT00734552
- Acronym / sponsor ID
- SYSU-KAPDRRF
- Conditions
- Peritoneal Dialysis
- Keywords
- Continuous Ambulatory Peritoneal Dialysis, α-Keto Acid, Low Protein Diet, Residual Renal Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Aug 2008 (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.
This randomized, open-label, prospective study will evaluate the renal effective effect of compound α-Keto Acid plus low protein diet in PD Patients.
Detailed description
Residual renal function (RRF) is associated with cardiovascular complication, nutritional status, incidence of peritonitis, and quality of life in peritoneal dialysis (PD) patients. Therefore, RRF is an important determinant of mortality and morbidity in PD patients.
Previous studies have suggested that dietary protein restriction supplemented with compound keto/amino acids may slow the loss of RRF in chronic kidney disease patients. However, there is very few reports to address the effect of compound keto/amino acid supplementation in RRF in PD patients.
The aim of this study is to evaluate the protective effect of compound α-Keto Acid plus low protein diet in RRF in PD Patients.This is a randomized, open-label, prospective study. 100 patients who meet Inclusion/Exclusion criteria will be randomized into α-Keto Acid group or control group at the ratio of 1:1. α-Keto Acid group will use compound α-Keto Acid plus low protein diet, while control group will use normal protein diet.Compound α-Keto Acid dosage is 0.1/kg/d daily. The effect of compound α-Keto Acid plus low protein diet in RRF 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
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: α-Keto Acid with low protein dietα-Keto Acid plus low protein diet |
| 2 | Other | Dietary Supplement: Normal protein dietNormal protein diet |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients on PD at least one month prior to study entry.
- Subjects of either sex, more than 20 years old, the range of age is 20 to 75 year old.
- Residual GFR ≥3 ml/min/1.73m2.
- Residual urine volume ≥ 500 ml/24h.
- No history of taking α-Keto Acid within 2 weeks.
Key exclusion criteria (5 listed)
- History of peritonitis or other infection within one month.
- History of taking drug which may affect amino acid metabolism within one month.
- Incapable of following study requirements to control diet.
- With severe cardiovascular disease, chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse.
- Participation in another clinic trial within one month prior to screening.
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 |
|---|---|---|
| α-Keto Acid with low protein dietAlso: Test GroupCompound α-Keto Acid: The daily dose of compound α-Keto Acid is 0.1/kg/d. The total daily dose will be divided into three times a day. Low Protein Diet: Diet contain protein 0.8g/kg/d. | Dietary supplement | 1 |
| Normal protein dietAlso: Control GroupDiet contain protein 1.0-1.2 g/kg/d. | Dietary supplement | 2 |
Primary outcome
The longitudinal change in residual glomerular filtration rate (GFR),residual urine volume
Time frame: Every 3 months
1 secondary outcome
Peritoneal membrane transport characteristics,cardiovascular events,nutritional status,hospitalization, peritonitis episodes, any adverse drug effects.
Time frame: Every 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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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.
Xueqing Yu, M.D. & Ph.D. principal investigator
1st Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing α-Keto Acid with low protein diet and Normal protein diet in people with Peritoneal Dialysis, run by Sun Yat-sen University 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 22 May 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The longitudinal change in residual glomerular filtration rate (GFR),residual urine volume (time frame: Every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2015.