Clinical trial NCT00565396: Effectiveness Study on Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3
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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Insufficiency
Angiotensin-Converting Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Proteinuria
Lead sponsor: Shanghai Municipal Health Bureau
Sponsor class: OTHER_GOV
First posted: 2007-11-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: progress to End Stage Renal Disease
timeFrame: within two years
measure: double of serum creatinine
timeFrame: within two years
measure: all cause mortality
timeFrame: within two years
Secondary outcomes:
measure: decreased proteinuria
timeFrame: within two years
Other outcomes:
Locations:
city: Taizhou
country: China
facility: Taizhou People's Hospital
state: Jiangsu
city: Hangzhou
country: China
facility: The 1st Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Guangxing Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Shaoyifu Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Lihuili Hospital
state: Zhejiang
city: Wenling
country: China
facility: Wenling 1st People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First affiliated Hospital of Wenzhou Medical College
state: Zhejiang
city: Xiangshan
country: China
facility: Xiangshan People's Hospital
state: Zhejiang
city: Shanghai
country: China
facility: Renji Hospital
city: Shanghai
country: China
facility: Changzheng Hospital
city: Shanghai
country: China
facility: Shanghai 9th People's Hospital
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital
city: Shanghai
country: China
facility: Huadong Hospital
city: Shanghai
country: China
facility: Huashan
city: Shanghai
country: China
facility: Shanghai 455 Hospital
city: Shanghai
country: China
facility: Shanghai 85 Hospital
city: Shanghai
country: China
facility: Tongji Hospital
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
city: Shanghai
country: China
facility: Shanghai 1st People's Hospital
city: Shanghai
country: China
facility: Shanghai Yangpu District Centre Hospital
city: Shanghai
country: China
facility: Xinhua Hospital
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Shanghai
country: China
facility: Shanghai 6th people's hospital
city: Shanghai
country: China
facility: Shanghai Changning District Centre Hospital
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Ruijin Hospital
name: Nan Chen, M.D.
role: STUDY_CHAIR
References: