An interventional study of α-Keto Acid with restricted protein diet and Placebo plus restricted protein diet in Renal Function Disorder, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-05-22.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
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.
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.
Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Also known as: Test Group
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.
Also known as: 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
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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