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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

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)

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

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

Lead Sponsor: Shanghai Municipal Health Bureau

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on October 10, 2008

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