Renal Protective Effects of Restricted Protein Dietary With α-keto Acid in CAPD Patients

Not Applicable

Completed

• Conditions: Renal Function Disorder
• Interventions: Drug: α-Keto Acid with restricted protein diet; Drug: Placebo plus restricted protein diet

• Registration Number: NCT01255020
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The prospective, double blind randomized, parallel control, and multi-center clinical trial will evaluate the safety and efficacy of α-keto acid with restricted protein diet on protecting residual renal function in continuous ambulatory peritoneal dialysis (CAPD) 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 α-keto acids may slow the loss of RRF in chronic kidney disease patients. However, these trials are small sample and short-time research. In PD patients, there is very few reports to indicate the effect of α-keto acid with restricted protein diet on RRF.

The aim of this study is to evaluate the safety and efficacy of α-keto acid with restricted protein diet on protecting residual renal function in continuous ambulatory peritoneal dialysis (CAPD) patients.This is a prospective, double blind randomized, parallel control, and multi-center clinical study. 160 patients who meet Inclusion/Exclusion criteria will be randomized into α-Keto Acid group or control group at the ratio of 1:1. The α-Keto Acid group will use compound α-Keto Acid plus restricted protein diet, while control group will use placebo plus restricted protein diet.The α-Keto Acid dosage is 100mg/kg/d daily. The restricted protein dosage is 1g/kg/d. The safety and efficacy of α-Keto Acid with restricted protein diet on RRF will be evaluated after 1 year treatment.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Patients on peritoneal dialysis (PD) at least three month prior to study entry.
2. Subjects of either sex, more than 18 years old, the range of age is 18 to 70 year old.
3. Residual GFR ≥ 3 ml/min/1.73m2.
4. Without α-Keto Acid therapy in recent 4 weeks.
5. 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. Patients with insufficient dialysis.
3. History of taking drug which may influence amino acid metabolism within one month(glucocorticoid, thyroxin, antithyroid drug, androgens,amino acids,et al).
4. Patients with diseases which contraindicate ketosteril.
5. Cannot control diet according to protocol.
6. Alcohol abuse or drug abuse.
7. Having malignant tumor.
8. History of psychiatric or neuropathic dysfunction.
9. Cardiac failure, with New York Heart Association (NYHA) grade III-IV or history of severe heart and cerebrovascular disease in recent one month(acute stroke, acute heart failure, Lability angina)
10. Serum albumin < 30g/l.
11. Serum calcium > 2.8mmol/l.
12. Participation in another clinic trial within last three months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
α-Keto Acid plus restricted protein diet	α-Keto Acid with restricted protein diet	Participants randomized to this group will receive 12 months treatment of α-Keto Acid. The dose of α-Keto Acid is 100mg/kg per day and will divided into three times per day, and the α-Keto Acid will be asked to be taken during the meal. In addition, the participants will be asked to restrict the protein intake. The protein intake is restricted as 1g/kg/d.
Placebo plus restricted protein diet	Placebo plus restricted protein diet	All participants will receive 12 months treatment of placebo, at the same time they will be asked to restrict the protein intake.The dose of placebo is 100mg/kg per day, and the protein intake is restricted as 1g/kg/d.

Primary Outcome Measures

Name	Time	Method
The longitudinal change in residual glomerular filtration rate (GFR)	Every 3 months up to 12 months

Secondary Outcome Measures

Name	Time	Method
Nutritional status	Every 3 months up to 12 months
Hospitalization	Every 3 months up to 12 months
Peritoneal membrane transport characteristics	Every 3 months up to 12 months
Cardiovascular events	Every 3 months up to 12 months

Trial Locations

Locations (1)

The 1st Affiliated Hospital, Sun Yet-sen University; 🇨🇳 GuangZhou, Guangdong, China