Renal Function Disorder
Conditions
Keywords
Continuous Ambulatory Peritoneal Dialysis, Angiotensin-converting Enzyme Inhibitor, Angiotensin II Receptor Blocker, Renin angiotensin system inhibitor, Residual Renal Function
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.
Interventions
DRUGBenazepril
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.
DRUGValsartan
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.
DRUGBenazepril+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.
DRUGControl
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed