Overview

This trial is active, not recruiting.

Conditions chronic kidney insufficiency, angiotensin-converting enzyme inhibitors, angiotensin ii type 1 receptor blockers, proteinuria
Treatment fosinopril and losartan
Sponsor Shanghai Municipal Health Bureau
Start date September 2004
End date July 2008
Trial size 400 participants
Trial identifier NCT00565396, 2003ZD002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Fosinopril 10mg/day(oral)
fosinopril and losartan
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
(Active Comparator)
Fosinopril 20mg/day(oral)
fosinopril and losartan
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
(Active Comparator)
Losartan 50mg/day(oral)
fosinopril and losartan
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
(Active Comparator)
Losartan 100mg/day(oral)
fosinopril and losartan
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)

Primary Outcomes

Measure
progress to End Stage Renal Disease
time frame: within two years
double of serum creatinine
time frame: within two years
all cause mortality
time frame: within two years

Secondary Outcomes

Measure
decreased proteinuria
time frame: within two years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Multi-Center,Double-Blind,Randomized,Controlled Clinical Trial of Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3
Trial information was received from ClinicalTrials.gov and was last updated in November 2007.
Information provided to ClinicalTrials.gov by Shanghai Municipal Health Bureau.