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Completed

NCT Number: NCT00721773

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

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benazepril

Drug

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.

Other names: Benazepril group

valsartan

Drug

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.

Other names: Valsartan group

Benazepril+Valsartan

Drug

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.

Other names: Benazepril plus Valsartan group

Control

Drug

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.

Other names: Control group

Primary outcomes

  1. The longitudinal change in residual glomerular filtration rate (GFR)

    Time frame: 3 years

    Residual GFR is defined as the average of 24-hour urinary urea and creatinine clearances.

Secondary outcomes

  1. Dialysis adequacy

    Time frame: 3 years

    Indices of the adequacy of dialysis include Kt/V and weekly creatinine clearance assessed by 24-hour dialysate and urinary collection.

  2. Peritoneal membrane function

    Time frame: 3 years

    Peritoneal membrane function assessed by standard peritoneal equilibration test.

  3. Blood pressure

    Time frame: 3 years

    Office systolic and diastolic blood pressure measurement during follow up period.

  4. The time to anuria

    Time frame: 3 years

    Anuria is defined as urine volume < 100ml/d.

  5. Number of participants not alive

    Time frame: 3 years

    Death from any cause.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jul 24, 2008
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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