Renal Protective Effects of Restricted Protein Dietary With α-keto Acid in CAPD Patients
|ClinicalTrials.gov Identifier: NCT01255020|
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : May 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Renal Function Disorder||Drug: α-Keto Acid with restricted protein diet Drug: Placebo plus restricted protein diet||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Start Date :||March 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Active Comparator: α-Keto Acid plus 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.
Drug: α-Keto Acid with restricted protein diet
α-Keto Acid: The daily dose of compound α-Keto Acid is 100mg/kg/d. The total daily dose will be divided into three times a day.
Restricted Protein Diet: Diet contain protein 1.0g/kg/d
Other Name: Test Group
Placebo Comparator: 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.
Drug: Placebo plus restricted protein diet
placebo: The daily dose of placebo is 100mg/kg/d. The total daily dose will be divided into three times a day.
Diet contain protein 1.0 g/kg/d.
Other Name: Control Group
- The longitudinal change in residual glomerular filtration rate (GFR) [ Time Frame: Every 3 months up to 12 months ]
- Peritoneal membrane transport characteristics [ Time Frame: Every 3 months up to 12 months ]
- Cardiovascular events [ Time Frame: Every 3 months up to 12 months ]
- Nutritional status [ Time Frame: Every 3 months up to 12 months ]
- Hospitalization [ Time Frame: Every 3 months up to 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255020
|The 1st Affiliated Hospital, Sun Yet-sen University|
|GuangZhou, Guangdong, China, 510080|
|Principal Investigator:||Xueqing YU, M.D. & Ph.D.||1st Affiliated Hospital, Sun Yat-Sen University|
|Principal Investigator:||Lan Chen, M.D. & Ph.D||Ruijin Hospital|
|Principal Investigator:||Jianghua Chen, M.D. & Ph.D||First Affiliated Hospital of Zhejiang University|
|Principal Investigator:||Zhangsuo Liu, M.D. & Ph.D||The First Affiliated Hospital of Zhengzhou University|
|Principal Investigator:||Fei Xiong, M.D.||Wuhan Chinese and Western Medicine Combined Hospital|
|Principal Investigator:||Qinfeng Han, M.D.&Ph.D||Peking University Third Hospital|