Clinical trial NCT00734552: Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Renal Function in PD Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritoneal Dialysis
Keywords: Continuous Ambulatory Peritoneal Dialysis
α-Keto Acid
Low Protein Diet
Residual Renal Function
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2008-08-14
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: The longitudinal change in residual glomerular filtration rate (GFR),residual urine volume
timeFrame: Every 3 months
Secondary outcomes:
measure: Peritoneal membrane transport characteristics,cardiovascular events,nutritional status,hospitalization, peritonitis episodes, any adverse drug effects.
timeFrame: Every 3 months
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: The 1st Affiliated Hospital, Sun Yet-sen University
state: Guangdong
Study officials:
affiliation: 1st Affiliated Hospital, Sun Yat-Sen University
name: Xueqing Yu, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: