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

Verified by: Shanghai Municipal Health Bureau, November 2007
First Received: November 28, 2007 | Last Updated: November 29, 2007 | Phase: N/A | Start Date: September 2004
Overall Status: Active, not recruiting | Estimated Enrollment: 400
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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...

Brief Summary

Official Title: “Multi-Center,Double-Blind,Randomized,Controlled Clinical Trial of Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: Fosinopril and Losartan
    • Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • Fosinopril 10mg/day(oral)
  • Active Comparator: 2
    • Fosinopril 20mg/day(oral)
  • Active Comparator: 3
    • Losartan 50mg/day(oral)
  • Active Comparator: 4
    • Losartan 100mg/day(oral)

Outcome Measures for this Clinical Trial

Primary Measures

  • progress to End Stage Renal Disease
    • Time Frame: within two years
      Safety Issue?: Yes
  • double of serum creatinine
    • Time Frame: within two years
      Safety Issue?: Yes
  • all cause mortality
    • Time Frame: within two years
      Safety Issue?: Yes

Secondary Measures

  • decreased proteinuria
    • Time Frame: within two years
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Shanghai Municipal Health Bureau Other

Overall Clinical Trial Officials and Contacts

Nan Chen, M.D. Study Chair Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00565396

Study ID Number: 2003ZD002

ClinicalTrials.gov Identifier: NCT00565396

Health Authority: China: State Food and Drug Administration

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00565396