Study to Evaluate the Protective Effect of α-Keto Acid With Low-Protein Diet (LPD) on Renal Function (RRF) in Peritoneal Dialysis (PD) Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00734552
First received: August 13, 2008
Last updated: March 9, 2009
Last verified: March 2009
  Purpose

This randomized, open-label, prospective study will evaluate the renal effective effect of compound α-Keto Acid plus low protein diet in PD Patients.


Condition Intervention
Continuous Ambulatory Peritoneal Dialysis
Dietary Supplement: α-Keto Acid with low protein diet
Dietary Supplement: Normal protein diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • The longitudinal change in residual glomerular filtration rate (GFR),residual urine volume [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Peritoneal membrane transport characteristics,cardiovascular events,nutritional status,hospitalization, peritonitis episodes, any adverse drug effects. [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: October 2007
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
α-Keto Acid plus low protein diet
Dietary Supplement: α-Keto Acid with low protein diet

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.

Other Name: Test Group
2
Normal protein diet
Dietary Supplement: Normal protein diet
Diet contain protein 1.0-1.2 g/kg/d.
Other Name: Control Group

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients on PD at least one month prior to study entry.
  2. Subjects of either sex, more than 20 years old, the range of age is 20 to 75 year old.
  3. Residual GFR ≥3 ml/min/1.73m2.
  4. Residual urine volume ≥ 500 ml/24h.
  5. No history of taking α-Keto Acid within 2 weeks.
  6. Subjects who agree to participate in the study and sign the informed consent.

Exclusion Criteria:

  1. History of peritonitis or other infection within one month.
  2. History of taking drug which may affect amino acid metabolism within one month.
  3. Incapable of following study requirements to control diet.
  4. With severe cardiovascular disease, chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse.
  5. Participation in another clinic trial within one month prior to screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734552

Contacts
Contact: Xueqing Yu, M.D.& Ph.D. 8620-87766335 yuxq@mail.sysu.edu.cn
Contact: Haiping Mao, M.D.& Ph.D. 8620-87755766 ext 8143 haipingmao@126.com

Locations
China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University Recruiting
GuangZhou, Guangdong, China, 510080
Contact: Xueqing Yu, M.D. & Ph.D.    8620-87766335    yuxq@mail.sysu.edu.cn   
Contact: Haiping Mao, M.D. & Ph.D.    8620-87755766 ext 8143    haipingmao@126.com   
Principal Investigator: Xueqing Yu, M.D.& Ph.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Xueqing Yu, M.D. & Ph.D. 1st Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Xueqing Yu/Director, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00734552     History of Changes
Other Study ID Numbers: SYSU-KAPDRRF
Study First Received: August 13, 2008
Last Updated: March 9, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Continuous Ambulatory Peritoneal Dialysis
α-Keto Acid
Low Protein Diet
Residual Renal Function

ClinicalTrials.gov processed this record on October 20, 2014