Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Renal Function in PD Patients

This study has been completed.
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University Identifier:
First received: August 13, 2008
Last updated: May 20, 2015
Last verified: May 2015

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
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

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 ]

Enrollment: 100
Study Start Date: October 2007
Study Completion Date: May 2010
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
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.


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

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
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Please refer to this study by its identifier: NCT00734552

China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University
GuangZhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Principal Investigator: Xueqing Yu, M.D. & Ph.D. 1st Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Xue Qing Yu, Professor, Sun Yat-sen University Identifier: NCT00734552     History of Changes
Other Study ID Numbers: SYSU-KAPDRRF
Study First Received: August 13, 2008
Last Updated: May 20, 2015
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 processed this record on October 08, 2015