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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fosinopril and Losartan
Sponsored by
Shanghai Municipal Health Bureau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Insufficiency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taizhou People's Hospital
  • The 1st Affiliated Hospital of College of Medicine, Zhejiang University
  • Guangxing Hospital
  • Shaoyifu Hospital
  • Ningbo Lihuili Hospital
  • Wenling 1st People's Hospital
  • The First affiliated Hospital of Wenzhou Medical College
  • Xiangshan People's Hospital
  • Renji Hospital
  • Changzheng Hospital
  • Shanghai 9th People's Hospital
  • Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
  • Zhongshan Hospital
  • Huadong Hospital
  • Huashan
  • Shanghai 455 Hospital
  • Shanghai 85 Hospital
  • Tongji Hospital
  • Shanghai 10th People's Hospital
  • Shanghai 1st People's Hospital
  • Shanghai Yangpu District Centre Hospital
  • Xinhua Hospital
  • Shanghai East Hospital
  • Shanghai 6th people's hospital
  • Shanghai Changning District Centre Hospital
  • Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Fosinopril 10mg/day(oral)

Fosinopril 20mg/day(oral)

Losartan 50mg/day(oral)

Losartan 100mg/day(oral)

Outcomes

Primary Outcome Measures

progress to End Stage Renal Disease
double of serum creatinine
all cause mortality

Secondary Outcome Measures

decreased proteinuria

Full Information

First Posted
November 28, 2007
Last Updated
November 29, 2007
Sponsor
Shanghai Municipal Health Bureau
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1. Study Identification

Unique Protocol Identification Number
NCT00565396
Brief Title
Effectiveness Study on Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3
Acronym
FLIP
Official Title
Multi-Center,Double-Blind,Randomized,Controlled Clinical Trial of Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Municipal Health Bureau

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Insufficiency, Angiotensin-Converting Enzyme Inhibitors, Angiotensin II Type 1 Receptor Blockers, Proteinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Fosinopril 10mg/day(oral)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Fosinopril 20mg/day(oral)
Arm Title
3
Arm Type
Active Comparator
Arm Description
Losartan 50mg/day(oral)
Arm Title
4
Arm Type
Active Comparator
Arm Description
Losartan 100mg/day(oral)
Intervention Type
Drug
Intervention Name(s)
Fosinopril and Losartan
Intervention Description
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
Primary Outcome Measure Information:
Title
progress to End Stage Renal Disease
Time Frame
within two years
Title
double of serum creatinine
Time Frame
within two years
Title
all cause mortality
Time Frame
within two years
Secondary Outcome Measure Information:
Title
decreased proteinuria
Time Frame
within two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nan Chen, M.D.
Organizational Affiliation
Ruijin Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Taizhou People's Hospital
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
225300
Country
China
Facility Name
The 1st Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Guangxing Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310007
Country
China
Facility Name
Shaoyifu Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Ningbo Lihuili Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315000
Country
China
Facility Name
Wenling 1st People's Hospital
City
Wenling
State/Province
Zhejiang
ZIP/Postal Code
317500
Country
China
Facility Name
The First affiliated Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Xiangshan People's Hospital
City
Xiangshan
State/Province
Zhejiang
ZIP/Postal Code
315700
Country
China
Facility Name
Renji Hospital
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Changzheng Hospital
City
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Shanghai 9th People's Hospital
City
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Zhongshan Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Huadong Hospital
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Huashan
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai 455 Hospital
City
Shanghai
ZIP/Postal Code
200052
Country
China
Facility Name
Shanghai 85 Hospital
City
Shanghai
ZIP/Postal Code
200052
Country
China
Facility Name
Tongji Hospital
City
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Shanghai 10th People's Hospital
City
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
Shanghai 1st People's Hospital
City
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Shanghai Yangpu District Centre Hospital
City
Shanghai
ZIP/Postal Code
200090
Country
China
Facility Name
Xinhua Hospital
City
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
Shanghai 6th people's hospital
City
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Name
Shanghai Changning District Centre Hospital
City
Shanghai
ZIP/Postal Code
200336
Country
China
Facility Name
Changhai Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

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

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