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

Proteinuria Clinical Trial

— FLIP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00565396
• Other study ID #: 2003ZD002
• Secondary ID: 2003ZD002
• Status: Active, not recruiting
• Phase: N/A
• First received: November 28, 2007
• Last updated: November 29, 2007
• Start date: September 2004
• Est. completion date: July 2008

Study information

• Verified date: November 2007
• Source: Shanghai Municipal Health Bureau
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Angiotensin II Type 1 Receptor Blockers
• Angiotensin-Converting Enzyme Inhibitors
• Chronic Kidney Insufficiency
• Kidney Diseases
• Proteinuria
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
China	Guangxing Hospital	Hangzhou	Zhejiang
China	Shaoyifu Hospital	Hangzhou	Zhejiang
China	The 1st Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Ningbo Lihuili Hospital	Ningbo	Zhejiang
China	Changhai Hospital	Shanghai
China	Changzheng Hospital	Shanghai
China	Huadong Hospital	Shanghai
China	Huashan	Shanghai
China	Renji Hospital	Shanghai
China	Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine	Shanghai
China	Shanghai 10th People's Hospital	Shanghai
China	Shanghai 1st People's Hospital	Shanghai
China	Shanghai 455 Hospital	Shanghai
China	Shanghai 6th people's hospital	Shanghai
China	Shanghai 85 Hospital	Shanghai
China	Shanghai 9th People's Hospital	Shanghai
China	Shanghai Changning District Centre Hospital	Shanghai
China	Shanghai East Hospital	Shanghai
China	Shanghai Yangpu District Centre Hospital	Shanghai
China	Tongji Hospital	Shanghai
China	Xinhua Hospital	Shanghai
China	Zhongshan Hospital	Shanghai
China	Taizhou People's Hospital	Taizhou	Jiangsu
China	Wenling 1st People's Hospital	Wenling	Zhejiang
China	The First affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang
China	Xiangshan People's Hospital	Xiangshan	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Municipal Health Bureau

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progress to End Stage Renal Disease		within two years	Yes
Primary	double of serum creatinine		within two years	Yes
Primary	all cause mortality		within two years	Yes
Secondary	decreased proteinuria		within two years	Yes