Renal Protective Effects of Renin Angiotensin System (RAS) Inhibitor in Peritoneal Dialysis Patients
- Conditions
- Renal Function Disorder
- Interventions
- Registration Number
- NCT00721773
- Lead Sponsor
- Sun Yat-sen University
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RAS inhibitors, benazepril+valsartan Benazepril+Valsartan Benazepril 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, control Control Drug: antihypertensive agents, except ACE inhibitors and ARBs. Administration of antihypertensive agents will select as follows: CCB→β-blocker→α-blocker. ACE inhibitor, benazepril Benazepril Benazepril 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, valsartan Valsartan Valsartan will be started at 80 mg/day and will be up-titrated to 160 mg/day according to BP control and tolerability.
- Primary Outcome Measures
Name Time Method The longitudinal change in residual glomerular filtration rate (GFR) 3 years Residual GFR is defined as the average of 24-hour urinary urea and creatinine clearances.
- Secondary Outcome Measures
Name Time Method Dialysis adequacy 3 years Indices of the adequacy of dialysis include Kt/V and weekly creatinine clearance assessed by 24-hour dialysate and urinary collection.
Peritoneal membrane function 3 years Peritoneal membrane function assessed by standard peritoneal equilibration test.
Blood pressure 3 years Office systolic and diastolic blood pressure measurement during follow up period.
The time to anuria 3 years Anuria is defined as urine volume \< 100ml/d.
Number of participants not alive 3 years Death from any cause.
Trial Locations
- Locations (1)
The 1st Affiliated Hospital, Sun Yet-sen University
🇨🇳GuangZhou, Guangdong, China