Peritoneal Membrane Failure Clinical Trial
Official title:
The Effect of Aliskiren and Losartan on Peritoneal Membrane in Continuous Ambulatory Peritoneal Dialysis Patients
This is a prospective, randomized, placebo controlled, multi-center clinical trial to determine whether aliskiren or aliskiren plus losartan or enalapril plus losartan effects on peritoneal membrane transportation.
Detailed description:
Many peritoneal dialysis patients suffer from uremia due to inadequate dialysis or volume
overload caused by failure of peritoneal membrane transportation. One of the most important
etiologies of peritoneal membrane failure is unavoidable to use high glucose-containing
dialysate solution that induces injury to mesothelial cells. Previous data found that
injured mesothelial cell produced Angiotensin II inducing peritoneal inflammation and
fibrosis. Blockade of the renin-angiotensin system by angiotensin-converting enzyme
inhibition or angiotensin receptor antagonism play a major role to slow these effects.
Many trials in animal studies have proved the benefit of angiotensin-converting enzyme
inhibition and angiotensin receptor antagonism in preservation of peritoneal membrane but
clinical evidences in human are controversy in the past. Recently our data have demonstrated
the roles of angiotensin-converting enzyme inhibition and angiotensin receptor antagonism
for slowing peritoneal membrane dysfunction in views of anatomy and solute transportation
(abstract presentation in American Society of Nephrology 2010). These available data
confirmed that renin-angiotensin system blockages were benefit. Nowadays, there is a new
class of antihypertensive drug, called direct renin inhibitor . It blocks (pro)renin active
site that is the rate- limiting step of renin-angiotensin system. We're interesting in this
drug and wonder it can slow the peritoneal membrane dysfunction in continuous ambulatory
peritoneal dialysis patients. Therefore, we design a study to show the effect of aliskiren
alone or combination with angiotensin receptor antagonism for slowing peritoneal membrane
dysfunction in naive continuous ambulatory peritoneal dialysis patients in several
hospitals. Our study will be taken in 1 year duration and uses modified peritoneal
equilibrium test and dialysate cancer antigen 125 (CA125) as indexes of peritoneal membrane
transportations.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment