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

Not Applicable

• Conditions: Chronic Kidney Insufficiency; Angiotensin-Converting Enzyme Inhibitors; Angiotensin II Type 1 Receptor Blockers; Proteinuria
• Interventions: Drug: Fosinopril and Losartan

• Registration Number: NCT00565396
• Lead Sponsor: Shanghai Municipal Health Bureau

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Status Verified: 2007-11
• Study First Submitted: 2007-11-28
• Study First Submitted QC: 2007-11-29
• Last Update Submitted: 2007-11-29
• Study First Posted: 2007-11-30
• Last Update Posted: 2007-11-30
• Study Completion: 2008-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fosinopril and Losartan	Fosinopril 10mg/day(oral)
2	Fosinopril and Losartan	Fosinopril 20mg/day(oral)
3	Fosinopril and Losartan	Losartan 50mg/day(oral)
4	Fosinopril and Losartan	Losartan 100mg/day(oral)

Primary Outcome Measures

Name	Time	Method
progress to End Stage Renal Disease	within two years
double of serum creatinine	within two years
all cause mortality	within two years

Secondary Outcome Measures

Name	Time	Method
decreased proteinuria	within two years

Trial Locations

Locations (26)

Xiangshan People's Hospital; 🇨🇳 Xiangshan, Zhejiang, China

Renji Hospital; 🇨🇳 Shanghai, China

Shanghai 6th people's hospital; 🇨🇳 Shanghai, China

Shanghai Changning District Centre Hospital; 🇨🇳 Shanghai, China

Shaoyifu Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Taizhou People's Hospital; 🇨🇳 Taizhou, Jiangsu, China

The 1st Affiliated Hospital of College of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Zhongshan Hospital; 🇨🇳 Shanghai, China

Changhai Hospital; 🇨🇳 Shanghai, China

Guangxing Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Ningbo Lihuili Hospital; 🇨🇳 Ningbo, Zhejiang, China

Wenling 1st People's Hospital; 🇨🇳 Wenling, Zhejiang, China

The First affiliated Hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China

Changzheng Hospital; 🇨🇳 Shanghai, China

Shanghai 9th People's Hospital; 🇨🇳 Shanghai, China

Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, China

Huadong Hospital; 🇨🇳 Shanghai, China

Huashan; 🇨🇳 Shanghai, China

Shanghai 455 Hospital; 🇨🇳 Shanghai, China

Shanghai 85 Hospital; 🇨🇳 Shanghai, China

Shanghai 10th People's Hospital; 🇨🇳 Shanghai, China

Tongji Hospital; 🇨🇳 Shanghai, China

Shanghai 1st People's Hospital; 🇨🇳 Shanghai, China

Shanghai Yangpu District Centre Hospital; 🇨🇳 Shanghai, China

Shanghai East Hospital; 🇨🇳 Shanghai, China

Xinhua Hospital; 🇨🇳 Shanghai, China