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

Peritoneal Dialysis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734552
• Other study ID #: SYSU-KAPDRRF
• Status: Completed
• Phase: N/A
• First received: August 13, 2008
• Last updated: May 20, 2015
• Start date: October 2007
• Est. completion date: May 2010

Study information

• Verified date: May 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 a-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.

Study Design

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

Related Conditions & MeSH terms

• Peritoneal Dialysis

Intervention

Dietary Supplement:
• a-Keto Acid with low protein diet
Compound a-Keto Acid: The daily dose of compound a-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.
• Normal protein diet
Diet contain protein 1.0-1.2 g/kg/d.

Locations

Country	Name	City	State
China	The 1st Affiliated Hospital, Sun Yet-sen University	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The longitudinal change in residual glomerular filtration rate (GFR),residual urine volume		Every 3 months	Yes
Secondary	Peritoneal membrane transport characteristics,cardiovascular events,nutritional status,hospitalization, peritonitis episodes, any adverse drug effects.		Every 3 months	Yes