NCT00721773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

6.1 years

First QC Date

July 22, 2008

Last Update Submit

May 18, 2015

Conditions

Renal Function Disorder

Keywords

Continuous Ambulatory Peritoneal DialysisAngiotensin-converting Enzyme InhibitorAngiotensin II Receptor BlockerRenin angiotensin system inhibitorResidual Renal Function

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Dialysis adequacy

    3 years

  • Peritoneal membrane function

    3 years

  • Blood pressure

    3 years

  • The time to anuria

    3 years

  • Number of participants not alive

    3 years

Study Arms (4)

ACE inhibitor, benazepril

EXPERIMENTAL

Benazepril will be started at 10 mg/day and will be up-titrated to 20 mg/day according to BP control and tolerability.

Drug: Benazepril

Angiotensin receptor blocker, valsartan

EXPERIMENTAL

Valsartan will be started at 80 mg/day and will be up-titrated to 160 mg/day according to BP control and tolerability.

Drug: Valsartan

RAS inhibitors, benazepril+valsartan

EXPERIMENTAL

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.

Drug: Benazepril+Valsartan

non-RAS inhibitors, control

ACTIVE COMPARATOR

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

Drug: Control

Interventions

BenazeprilDRUG

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.

Also known as: Benazepril group
ACE inhibitor, benazepril
ValsartanDRUG

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.

Also known as: Valsartan group
Angiotensin receptor blocker, valsartan
Benazepril+ValsartanDRUG

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.

Also known as: Benazepril plus Valsartan group
RAS inhibitors, benazepril+valsartan
ControlDRUG

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.

Also known as: Control group
non-RAS inhibitors, control

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Interventions

benazeprilValsartanControl Groups

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Xueqing Yu, M.D. & Ph.D.

    1st Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

  • Jianbo Liang, M.D.

    2nd Affiliated Hospital, Guangzhou Medical College

    PRINCIPAL INVESTIGATOR

  • Yunhua Liao, M.D.

    1st Affiliated Hospital, Guangxi Medical University

    PRINCIPAL INVESTIGATOR

  • Xinzhou Zhang, M.D. & Ph.D.

    Shenzhen People's Hospital

    PRINCIPAL INVESTIGATOR

  • Fei Xiong, M.D.

    Wuhan No.1 Hospital

    PRINCIPAL INVESTIGATOR

  • Hao Zhang, M.D.

    3rd Xiangya Hospital, Central South University

    PRINCIPAL INVESTIGATOR

  • Ping Fu, M.D. & Ph.D.

    West China Hospital

    PRINCIPAL INVESTIGATOR

  • Yonggui Wu, M.D.& Ph.D.

    1st Affiliated Hospital, Anhui Medical University

    PRINCIPAL INVESTIGATOR

  • Minghui Zhao, M.D.&Ph.D.

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

  • Xuewang Li, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

  • Li Hao, MD

    2nd Affiliated Hospital, Anhui Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 22, 2008

First Posted

July 24, 2008

Study Start

September 1, 2008

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

CN(1)