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Renal Function Disorder | Renal Protective Effects of Renin Angiotensin System (RAS) Inhibitor in Peritoneal Dialysis Patients

Renal Function Disorder research study

What is the primary objective of this study?

This is a multicentre study examining the effectiveness of angiotension converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or a combination of both in reducing the rate of decline in residual renal function (RRF) in continuous ambulatory peritoneal dialysis (CAPD) patients.

Who is eligible to participate?

Inclusion Criteria: - All patients received CAPD more than 1 months - Subjects of either sex, 20-75 years old - Residual GFR of 3mL/min per 1.73 m2 or more - With hypertension - No history of taking an ACE inhibitor or angiotensin-receptor blockers for at least 1 month - Provision of written informed consent by subject or guardian Exclusion Criteria: - Underlying medical conditions, such as congestive heart failure, or therapy with an ACE inhibitor or ARB - Peritonitis or volume overload within the preceding 1 month - Myocardial infarction within the preceding 6 months - Clinically significant valvular disease - Malignant hypertension - History of hypertensive encephalopathy or cerebrovascular accident within the preceding 6 months - Any condition that may have precluded a patient from remaining in the study, such as alcohol or drug abuse, chronic liver disease, malignant disease, or psychiatric disorder - History of allergy or intolerance to an ACE inhibitor or ARB - Participation in another clinic trial within 2 weeks prior to screening

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Renal Function Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:BenazeprilPatients with hypertension will take 10-20mg benazepril per day, antihypertensive agents other than ACE inhibitors and ARBs will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg.

Drug:ValsartanPatients with hypertension will take 80-160mg valsartan per day, antihypertensive agents other than ACE inhibitors and ARBs will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg.

Drug:Benazepril+ValsartanPatients with hypertension will take 10-20mg benazepril plus 80-160mg valsartan per day, antihypertensive agents other than ACE inhibitors and ARBs will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg.

Drug:ControlPatients in the control group will administer antihypertensive agents, except ACE inhibitors and ARBs. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ACE inhibitor, benazeprilBenazepril will be started at 10 mg/day and will be up-titrated to 20 mg/day according to BP control and tolerability.

Angiotensin receptor blocker, valsartanValsartan will be started at 80 mg/day and will be up-titrated to 160 mg/day according to BP control and tolerability.

RAS inhibitors, benazepril+valsartanBenazepril will be started at 10 mg/day and will be up-titrated to 20 mg/day, and valsartan will be started at 80 mg/day and will be up-titrated to 160 mg/day according to BP control and tolerability.

non-RAS inhibitors, controlDrug: antihypertensive agents, except ACE inhibitors and ARBs. Administration of antihypertensive agents will select as follows: CCB→β-blocker→α-blocker.

Study Status

Completed

Start Date: September 2008

Completed Date: October 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: The longitudinal change in residual glomerular filtration rate (GFR)

Secondary Outcome: Dialysis adequacy

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Sun Yat-sen University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00721773

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