Clinical trial NCT01255020: Renal Protective Effects of Restricted Protein Dietary With α-keto Acid in CAPD Patients
Official title: Safety and Efficacy Evaluation of Restricted Protein Dietary Supplemented With α-keto Acid on Protecting Residual Renal Function in CAPD Patients--A Prospective, Double Blind Randomized, Parallel Control, Multi-center Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Function Disorder
Keywords: α-Keto Acid
Restricted Protein Diet
Residual Renal Function
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Beijing Fresenius Kabi Pharmaceutical Co
First posted: 2010-12-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The longitudinal change in residual glomerular filtration rate (GFR)
timeFrame: Every 3 months up to 12 months
Secondary outcomes:
measure: Peritoneal membrane transport characteristics
timeFrame: Every 3 months up to 12 months
measure: Cardiovascular events
timeFrame: Every 3 months up to 12 months
measure: Nutritional status
timeFrame: Every 3 months up to 12 months
measure: Hospitalization
timeFrame: Every 3 months up to 12 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
affiliation: Ruijin Hospital
name: Lan Chen, M.D. & Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Zhejiang University
name: Jianghua Chen, M.D. & Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Zhangsuo Liu, M.D. & Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan Chinese and Western Medicine Combined Hospital
name: Fei Xiong, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Qinfeng Han, M.D.&Ph.D
role: PRINCIPAL_INVESTIGATOR
References: