Renal Function DisorderNCT01255020

Renal Protective Effects of Restricted Protein Dietary With α-keto Acid in CAPD Patients

A study testing α-Keto Acid with restricted protein diet in people with Renal Function Disorder, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The prospective, double blind randomized, parallel control, and multi-center clinical trial will evaluate the safety and efficacy of α-keto acid with restricted protein diet on protecting residual renal function in continuous ambulatory peritoneal dialysis (CAPD) patients. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Renal Function Disorder
What is being tested?: α-Keto Acid with restricted protein diet
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 1 siteChina
Study dates: Mar 2010to Dec 2013
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients on peritoneal dialysis (PD) at least three month prior to study entry.
Subjects of either sex, more than 18 years old, the range of age is 18 to 70 year old.
Residual GFR ≥ 3 ml/min/1.73m2.
Without α-Keto Acid therapy in recent 4 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.
Patients with insufficient dialysis.
History of taking drug which may influence amino acid metabolism within one month(glucocorticoid, thyroxin, antithyroid drug, androgens,amino acids,et al).
Patients with diseases which contraindicate ketosteril.
Cannot control diet according to protocol.
Alcohol abuse or drug abuse.

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Having malignant tumor.
History of psychiatric or neuropathic dysfunction.
Cardiac failure, with New York Heart Association (NYHA) grade III-IV or history of severe heart and cerebrovascular disease in recent one month(acute stroke, acute heart failure, Lability angina)
Serum albumin < 30g/l.
Serum calcium > 2.8mmol/l.
Participation in another clinic trial within last three months

Trial locations and contacts

1 site in 1 country.

China1 site

The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: Safety and Efficacy Evaluation of Restricted Protein Dietary Supplemented With α-keto Acid on Protecting Residual Renal Function in CAPD Patients--A Prospective, Double Blind Randomized, Parallel Control, Multi-center Clinical Trial

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 α-keto acids may slow the loss of RRF in chronic kidney disease patients. However, these trials are small sample and short-time research. In PD patients, there is very few reports to indicate the effect of α-keto acid with restricted protein diet on RRF.

The aim of this study is to evaluate the safety and efficacy of α-keto acid with restricted protein diet on protecting residual renal function in continuous ambulatory peritoneal dialysis (CAPD) patients.This is a prospective, double blind randomized, parallel control, and multi-center clinical study. 160 patients who meet Inclusion/Exclusion criteria will be randomized into α-Keto Acid group or control group at the ratio of 1:1. The α-Keto Acid group will use compound α-Keto Acid plus restricted protein diet, while control group will use placebo plus restricted protein diet.The α-Keto Acid dosage is 100mg/kg/d daily. The restricted protein dosage is 1g/kg/d. The safety and efficacy of α-Keto Acid with restricted protein diet on RRF will be evaluated after 1 year treatment.

Conditions: Renal Function Disorder
Being tested: α-Keto Acid with restricted protein diet, Placebo plus restricted protein diet
Keywords: α-Keto Acid, Restricted 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 restricted protein dietDrug
Also called Test Group
α-Keto Acid: The daily dose of compound α-Keto Acid is 100mg/kg/d. The total daily dose will be divided into three times a day.
Restricted Protein Diet: Diet contain protein 1.0g/kg/d
Placebo plus restricted protein dietDrug
Also called Control Group
placebo: The daily dose of placebo is 100mg/kg/d. The total daily dose will be divided into three times a day.
Diet contain protein 1.0 g/kg/d.

Study groups in NCT01255020
Study group	Role	What they receive
α-Keto Acid plus restricted protein diet	Active comparator	Participants randomized to this group will receive 12 months treatment of α-Keto Acid. The dose of α-Keto Acid is 100mg/kg per day and will divided into three times per day, and the α-Keto Acid will be asked to be taken during the meal. In addition, the participants will be asked to restrict the protein intake. The protein intake is restricted as 1g/kg/d. Receives: Drug: α-Keto Acid with restricted protein diet
Placebo plus restricted protein diet	Placebo comparator	All participants will receive 12 months treatment of placebo, at the same time they will be asked to restrict the protein intake.The dose of placebo is 100mg/kg per day, and the protein intake is restricted as 1g/kg/d. Receives: Drug: Placebo plus restricted 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)
Measured: Every 3 months up to 12 months

Secondary outcomes (4)

Peritoneal membrane transport characteristics
Measured: Every 3 months up to 12 months
Cardiovascular events
Measured: Every 3 months up to 12 months
Nutritional status
Measured: Every 3 months up to 12 months
Hospitalization
Measured: Every 3 months up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Dec 2013

First posted7 Dec 2010 (estimated)
Study startMar 2010
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal Function DisorderStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01255020
Sponsor's protocol ID: KAPDRRF
Status last verified: May 2015
First submitted: 11 Aug 2010
Last updated: 22 May 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Function Disorder trials

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: Safety and Efficacy Evaluation of Restricted Protein Dietary Supplemented With α-keto Acid on Protecting Residual Renal Function in CAPD Patients--A Prospective, Double Blind Randomized, Parallel Control, Multi-center Clinical Trial
ClinicalTrials.gov ID: NCT01255020
Acronym / sponsor ID: KAPDRRF
Conditions: Renal Function Disorder
Keywords: α-Keto Acid, Restricted Protein Diet, Residual Renal Function
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Collaborators: Beijing Fresenius Kabi Pharmaceutical Co
Study start: Mar 2010
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 7 Dec 2010 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
α-Keto Acid plus restricted protein diet	Active comparator	Drug: α-Keto Acid with restricted protein dietParticipants randomized to this group will receive 12 months treatment of α-Keto Acid. The dose of α-Keto Acid is 100mg/kg per day and will divided into three times per day, and the α-Keto Acid will be asked to be taken during the meal. In addition, the participants will be asked to restrict the protein intake. The protein intake is restricted as 1g/kg/d.
Placebo plus restricted protein diet	Placebo comparator	Drug: Placebo plus restricted protein dietAll participants will receive 12 months treatment of placebo, at the same time they will be asked to restrict the protein intake.The dose of placebo is 100mg/kg per day, and the protein intake is restricted as 1g/kg/d.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients on peritoneal dialysis (PD) at least three month prior to study entry.
Subjects of either sex, more than 18 years old, the range of age is 18 to 70 year old.
Residual GFR ≥ 3 ml/min/1.73m2.
Without α-Keto Acid therapy in recent 4 weeks.
Subjects who agree to participate in the study and sign the informed consent.

Key exclusion criteria (12 listed)

History of peritonitis or other infection within one month.
Patients with insufficient dialysis.
History of taking drug which may influence amino acid metabolism within one month(glucocorticoid, thyroxin, antithyroid drug, androgens,amino acids,et al).
Patients with diseases which contraindicate ketosteril.
Cannot control diet according to protocol.

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 restricted protein dietAlso: Test Groupα-Keto Acid: The daily dose of compound α-Keto Acid is 100mg/kg/d. The total daily dose will be divided into three times a day. Restricted Protein Diet: Diet contain protein 1.0g/kg/d	Drug	α-Keto Acid plus restricted protein diet
Placebo plus restricted protein dietAlso: Control Groupplacebo: The daily dose of placebo is 100mg/kg/d. The total daily dose will be divided into three times a day. Diet contain protein 1.0 g/kg/d.	Drug	Placebo plus restricted protein diet

Primary outcome

The longitudinal change in residual glomerular filtration rate (GFR)
Time frame: Every 3 months up to 12 months

4 secondary outcomes

Peritoneal membrane transport characteristics
Time frame: Every 3 months up to 12 months
Cardiovascular events
Time frame: Every 3 months up to 12 months
Nutritional status
Time frame: Every 3 months up to 12 months
Hospitalization
Time frame: Every 3 months up to 12 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.

Related trials for Renal Function Disorder

Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD
CKD (Chronic Kidney Disease) Stage 5D

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

Lan Chen, M.D. & Ph.D principal investigator

Ruijin Hospital

Jianghua Chen, M.D. & Ph.D principal investigator

First Affiliated Hospital of Zhejiang 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 restricted protein diet in people with Renal Function Disorder, 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 5 inclusion and 12 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. Some participants in this study may receive a placebo. 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) (time frame: Every 3 months up to 12 months). 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 NCT01255020.

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.