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.
Sponsor:
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00734552
First received: August 13, 2008
Last updated: May 20, 2015
Last verified: May 2015

August 13, 2008
May 20, 2015
October 2007
October 2009   (final data collection date for primary outcome measure)
The longitudinal change in residual glomerular filtration rate (GFR),residual urine volume [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00734552 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Renal Function in PD Patients
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Peritoneal Dialysis
  • 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
  • Dietary Supplement: Normal protein diet
    Diet contain protein 1.0-1.2 g/kg/d.
    Other Name: Control Group
  • Active Comparator: 1
    α-Keto Acid plus low protein diet
    Intervention: Dietary Supplement: α-Keto Acid with low protein diet
  • 2
    Normal protein diet
    Intervention: Dietary Supplement: Normal protein diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2010
October 2009   (final data collection date for primary outcome measure)

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.
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00734552
SYSU-KAPDRRF
Yes
Xue Qing Yu, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: Xueqing Yu, M.D. & Ph.D. 1st Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP