Effectiveness Study on Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3

NCT ID: NCT00565396

Last Updated: 2007-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this study is to determine whether fosinopril and losartan are effective in the treatment of patients with Chronic Kidney Disease(CKD) stage 3.

Detailed Description

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Conditions

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Chronic Kidney Insufficiency Angiotensin-Converting Enzyme Inhibitors Angiotensin II Type 1 Receptor Blockers Proteinuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Fosinopril 10mg/day(oral)

Group Type ACTIVE_COMPARATOR

Fosinopril and Losartan

Intervention Type DRUG

Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)

2

Fosinopril 20mg/day(oral)

Group Type ACTIVE_COMPARATOR

Fosinopril and Losartan

Intervention Type DRUG

Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)

3

Losartan 50mg/day(oral)

Group Type ACTIVE_COMPARATOR

Fosinopril and Losartan

Intervention Type DRUG

Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)

4

Losartan 100mg/day(oral)

Group Type ACTIVE_COMPARATOR

Fosinopril and Losartan

Intervention Type DRUG

Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)

Interventions

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Fosinopril and Losartan

Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18-75 years old
* Roll out secondary renal diseases
* Do not use steroids and immunosuppresive drugs
* ACEI/ARB treated patients should have 7-14 days wash out period,SiDBP\< 110mmHg
* Willing and able to comprehend and give written informed consent
* Willing to follow-up regularly

Exclusion Criteria

* Use steroids and immunosuppresive drugs
* Secondary renal diseases
* Acute cardio-cerebral diseases within 6 months
* Post renal transplantation
* Pregnant/Nursing women
* History of hypersensitivity to ACEI/ARB
* Refuse to join clinical trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Municipal Health Bureau

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine

Principal Investigators

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Nan Chen, M.D.

Role: STUDY_CHAIR

Ruijin Hospital

Locations

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Taizhou People's Hospital

Taizhou, Jiangsu, China

Site Status

The 1st Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Guangxing Hospital

Hangzhou, Zhejiang, China

Site Status

Shaoyifu Hospital

Hangzhou, Zhejiang, China

Site Status

Ningbo Lihuili Hospital

Ningbo, Zhejiang, China

Site Status

Wenling 1st People's Hospital

Wenling, Zhejiang, China

Site Status

The First affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status

Xiangshan People's Hospital

Xiangshan, Zhejiang, China

Site Status

Renji Hospital

Shanghai, , China

Site Status

Changzheng Hospital

Shanghai, , China

Site Status

Shanghai 9th People's Hospital

Shanghai, , China

Site Status

Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, , China

Site Status

Zhongshan Hospital

Shanghai, , China

Site Status

Huadong Hospital

Shanghai, , China

Site Status

Huashan

Shanghai, , China

Site Status

Shanghai 455 Hospital

Shanghai, , China

Site Status

Shanghai 85 Hospital

Shanghai, , China

Site Status

Tongji Hospital

Shanghai, , China

Site Status

Shanghai 10th People's Hospital

Shanghai, , China

Site Status

Shanghai 1st People's Hospital

Shanghai, , China

Site Status

Shanghai Yangpu District Centre Hospital

Shanghai, , China

Site Status

Xinhua Hospital

Shanghai, , China

Site Status

Shanghai East Hospital

Shanghai, , China

Site Status

Shanghai 6th people's hospital

Shanghai, , China

Site Status

Shanghai Changning District Centre Hospital

Shanghai, , China

Site Status

Changhai Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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2003ZD002

Identifier Type: -

Identifier Source: secondary_id

2003ZD002

Identifier Type: -

Identifier Source: org_study_id