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

Renal Function Disorder Clinical Trial

Official title:

Effects of Benazepril,Valsartan or Combination of Both on Residual Renal Function in Peritoneal Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721773
• Other study ID #: PDRRF
• Status: Completed
• Phase: N/A
• First received: July 22, 2008
• Last updated: May 18, 2015
• Start date: September 2008
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

RRF has been shown to decline progressively with time on dialysis in both CAPD and hemodialysis. Although RRF is an important determinant of mortality and morbidity in peritoneal dialysis (PD) patients, few studies have addressed therapeutic approaches for preserving RRF after the initiation of dialysis therapy. Blockade of the renin-angiotensin system by ACEI or ARB is a well-established approach for renoprotection in pre-dialysis chronic kidney disease patients. Up to now, only two trials showed that an ACEI, ramipril, and ARB, valsartan , were effective in the preservation of RRF of CAPD patients. However it is important to point out that the evidence cited has limitations. First, the trial only involved patients from one university teaching hospital. Second, transport characteristics, were not assessed before the start of the study. Third, the trial was too small to detect potentially important differences in health care use and survival between groups. Therefore, whether both ACEI and ARB preserve RRF, improve clinical outcomes and decrease health care use and costs should be tested in much longer and larger studies involving multiple sites. In order to confirm these findings, here the investigators will perform prospective, randomized, open-label and multiple center study to address long-term effects of ACEI, ARB and combination of both therapy on RRF in Patients on CAPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Function Disorder
• Renal Insufficiency

Intervention

Drug:
• Benazepril
Patients 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.
• Valsartan
Patients 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.
• Benazepril+Valsartan
Patients 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.
• Control
Patients 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.

Locations

Country	Name	City	State
China	The 1st Affiliated Hospital, Sun Yet-sen University	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The longitudinal change in residual glomerular filtration rate (GFR)	Residual GFR is defined as the average of 24-hour urinary urea and creatinine clearances.	3 years	No
Secondary	Dialysis adequacy	Indices of the adequacy of dialysis include Kt/V and weekly creatinine clearance assessed by 24-hour dialysate and urinary collection.	3 years	No
Secondary	Peritoneal membrane function	Peritoneal membrane function assessed by standard peritoneal equilibration test.	3 years	No
Secondary	Blood pressure	Office systolic and diastolic blood pressure measurement during follow up period.	3 years	Yes
Secondary	The time to anuria	Anuria is defined as urine volume < 100ml/d.	3 years	No
Secondary	Number of participants not alive	Death from any cause.	3 years	No