In China, the estimated prevalence of patients with ESRD receiving peritoneal dialysis (PD) or maintenance hemodialysis (HD) increased from 51.7 per million population (pmp) at the end of 2007 to 79.1 pmp at the end of 2008. There is a growing body of evidence that large uremic solutes play a significant role in clinical complications in dialysis patients. Since high-flux membranes show low permeability for large uremic solutes, extracorporeal blood purification treatments using these membranes have failed to significantly eliminate and reduce plasma levels of these molecules. To remove large sized uremic solutes by dialysis the membrane needs to have adequate permeability properties (pore size, porosity) for these solutes. The Theranova 400 contains a dialysis membrane that has a sharper sieving profile and a higher cutoff than that in conventional high-flux dialysis membranes. The primary objective of this study is to demonstrate non-inferiority of the Theranova Dialyzer compared to the FX80 with clinical endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
An existing functioning vascular access (AVF, graft) must be in place and will be used for dialysis. Treatments will be administered by trained clinical staff. The use of temporary or tunneled dialysis catheters will not be allowed.
An existing functioning vascular access (AVF, graft) must be in place and will be used for dialysis. Treatments will be administered by trained clinical staff. The use of temporary or tunneled dialysis catheters will not be allowed.
Investigational Site
Beijing, Beijing Municipality, China
Investigational Site
Guangzhou, Guangdong, China
Investigational Site
Chengdu, Sichuan, China
Investigational Site
Hangzhou, Zhejiang, China
Creatinine Clearance (K of Creatinine)
One mid-week dialysis session
Time frame: Up to 1 week
Urea Clearance (K of Urea)
One mid-week dialysis session
Time frame: Up to 1 week
Reduction Ratio (RR) of Beta-2 Microglobulin
One mid-week dialysis session
Time frame: Up to 1 week
Kappa and Lambda Free Light Chains (FLCs) Reduction Ratio
One mid-week dialysis session
Time frame: Up to 1 week
Ultrafiltration Rate (QUF)
One mid-week dialysis session
Time frame: Up to 1 week
Urea reduction ratio (URR)
One mid-week dialysis session
Time frame: Up to 1 week
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