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Status unknownNCT00565396FLIPUpdated Nov 30, 2007

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

An interventional study of Fosinopril and Losartan in Chronic Kidney Insufficiency, Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Type 1 Receptor Blockers, sponsored by Shanghai Municipal Health Bureau. Status unknown at 26 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-11-30.

Sponsored by Shanghai Municipal Health Bureau · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Kidney Insufficiency
  • Angiotensin-Converting Enzyme Inhibitors
  • Angiotensin II Type 1 Receptor Blockers
  • Proteinuria
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 400 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

This is the only study on the registry with Shanghai Municipal Health Bureau as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • Active comparator
    1

    Fosinopril 10mg/day(oral)

    Drug: Fosinopril and Losartan

  • Active comparator
    2

    Fosinopril 20mg/day(oral)

    Drug: Fosinopril and Losartan

  • Active comparator
    3

    Losartan 50mg/day(oral)

    Drug: Fosinopril and Losartan

  • Active comparator
    4

    Losartan 100mg/day(oral)

    Drug: Fosinopril and Losartan

Interventions

  • DrugFosinopril and Losartan

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

06

What researchers measure

Primary outcomes

  1. progress to End Stage Renal Disease

    Time frame: within two years

  2. double of serum creatinine

    Time frame: within two years

  3. all cause mortality

    Time frame: within two years

Secondary outcomes

  1. decreased proteinuria

    Time frame: within two years

07

Study locations

26 sites
  • Taizhou People's Hospital
    Taizhou, Jiangsu 225300, China
  • The 1st Affiliated Hospital of College of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310003, China
  • Guangxing Hospital
    Hangzhou, Zhejiang 310007, China
  • Shaoyifu Hospital
    Hangzhou, Zhejiang 310016, China
  • Ningbo Lihuili Hospital
    Ningbo, Zhejiang 315000, China
  • Wenling 1st People's Hospital
    Wenling, Zhejiang 317500, China
  • The First affiliated Hospital of Wenzhou Medical College
    Wenzhou, Zhejiang 325000, China
  • Xiangshan People's Hospital
    Xiangshan, Zhejiang 315700, China
  • Renji Hospital
    Shanghai, 200001, China
  • Changzheng Hospital
    Shanghai, 200003, China
  • Shanghai 9th People's Hospital
    Shanghai, 200011, China
  • Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
    Shanghai, 200025, China
  • Zhongshan Hospital
    Shanghai, 200032, China
  • Huadong Hospital
    Shanghai, 200040, China
  • Huashan
    Shanghai, 200040, China
  • Shanghai 455 Hospital
    Shanghai, 200052, China
  • Shanghai 85 Hospital
    Shanghai, 200052, China
  • Tongji Hospital
    Shanghai, 200065, China
  • Shanghai 10th People's Hospital
    Shanghai, 200072, China
  • Shanghai 1st People's Hospital
    Shanghai, 200080, China
  • Shanghai Yangpu District Centre Hospital
    Shanghai, 200090, China
  • Xinhua Hospital
    Shanghai, 200092, China
  • Shanghai East Hospital
    Shanghai, 200120, China
  • Shanghai 6th people's hospital
    Shanghai, 200233, China
  • Shanghai Changning District Centre Hospital
    Shanghai, 200336, China
  • Changhai Hospital
    Shanghai, 200433, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00565396
Lead sponsor
Shanghai Municipal Health Bureau
First posted
Nov 30, 2007
Start date
Sep 2004
Completion
Jul 2008 (estimated)
Last update
Nov 30, 2007

Study contacts

Nan Chen, M.D.
study chair · Ruijin Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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