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

Sponsored by:	Sun Yat-sen University
Information provided by:	Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT00734552

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

MedlinePlus related topics: Dietary Supplements Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 ]

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
1: Active Comparator 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.
2 Normal protein diet	Dietary Supplement: Normal protein diet Diet contain protein 1.0-1.2 g/kg/d.

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:

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

Exclusion Criteria:

History of peritonitis or other infection within one month.
History of taking drug which may affect amino acid metabolism within one month.
Incapable of following study requirements to control diet.
With severe cardiovascular disease, chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse.
Participation in another clinic trial within one month prior to screening.

Contacts and Locations

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

Responsible Party:	Sun Yat-sen University ( Xueqing Yu/Director )
Study ID Numbers:	SYSU-KAPDRRF
Study First Received:	August 13, 2008
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00734552
Health Authority:	China: State 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 January 16, 2009