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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:
ClinicalTrials.gov Identifier:
NCT00734552
First Posted: August 14, 2008
Last Update Posted: May 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University
  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
Peritoneal Dialysis Dietary Supplement: α-Keto Acid with low protein diet Dietary Supplement: Normal protein diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Xue Qing Yu, Sun Yat-sen University:

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

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

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
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734552


Locations
China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University
GuangZhou, Guangdong, China, 510080
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

Responsible Party: Xue Qing Yu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00734552     History of Changes
Other Study ID Numbers: SYSU-KAPDRRF
First Submitted: August 13, 2008
First Posted: August 14, 2008
Last Update Posted: May 22, 2015
Last Verified: May 2015

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