NCT01041963

Brief Summary

A prospective, randomized, open-label, Single-center clinical trial to determine whether Enalapril or Enalapril plus Losartan effect on Peritoneal membrane transportation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 12, 2010

Status Verified

May 1, 2010

Enrollment Period

1 year

First QC Date

January 4, 2010

Last Update Submit

May 9, 2010

Conditions

Continuous Ambulatory Peritoneal Dialysis

Keywords

ACEIARBCAPDPeritoneal membrane transport

Outcome Measures

Primary Outcomes (1)

  • Change in dialysate CA-125 and modified peritoneal equilibrium test

    12 months

Secondary Outcomes (1)

  • Dialysis adequacy, residual renal function, hospitalization, peritonitis episodes, any adverse drug effects, death from any cause

    every 1 month, except for dialysis adequacy evaluate every 3 mo

Study Arms (3)

Enalapril

ACTIVE COMPARATOR
Drug: Enalapril

Enalapril plus Losartan

ACTIVE COMPARATOR
Drug: Enalapril plus Losartan

Control

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

EnalaprilDRUG

Patients with hypertension will take 20-40mg enalapril per day, antihypertensive agents other than ACE inhibitors and ARBs and spironolactone will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg

Also known as: Anapril
Enalapril
Enalapril plus LosartanDRUG

Patients with hypertension will take 20-40mg enalapril plus 25-50mg losartan per day, antihypertensive agents other than ACE inhibitors and ARBs and spironolactone will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg

Also known as: Anapril plus Loranta
Enalapril plus Losartan
PlaceboDRUG

Patients in the control group will administer antihypertensive agents, except ACE inhibitors and ARBs and spironolactone. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg

Also known as: Control
Control

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients received CAPD more than 1 months but less than 1 year
  • Subjects of either sex, more than 20 years old
  • Hypertension
  • Provision of written informed consent by subject or guardian

You may not qualify if:

  • No history of taking an ACE inhibitor or angiotensin-receptor blockers or aldosterone antagonist for at least 2 month
  • Serum potassium more than 5.5 mEq/L
  • History of renal artery stenosis
  • Peritonitis or volume overload within the preceding 1 month
  • Myocardial infarction within the preceding 6 months or clinically significant valvular disease or any active cardiovascular disease
  • History of malignant hypertension or 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
  • Hypotension defined as systolic blood pressure less than 90 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn university

Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Interventions

EnalaprilLosartan

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Talerngsak Kanjanabuch, Assist. Prf.

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Talerngsak Kanjanabuch, Assist. Prf.

CONTACT

662-2564321golfnephro@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 5, 2010

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

September 1, 2010

Last Updated

May 12, 2010

Record last verified: 2010-05

Locations

TH(1)