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

Condition(s) targeted: Chronic Kidney Insufficiency; Angiotensin-Converting Enzyme Inhibitors; Angiotensin II Type 1 Receptor Blockers; Proteinuria

Intervention: Fosinopril and Losartan (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Shanghai Municipal Health Bureau

Official(s) and/or principal investigator(s):
Nan Chen, M.D., Study Chair, Affiliation: Ruijin Hospital Shanghai Jiao Tong University School of Medicine

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.

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

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

Primary outcome:

progress to End Stage Renal Disease

double of serum creatinine

all cause mortality

Secondary outcome: decreased proteinuria

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Changhai Hospital, Shanghai 200433, China

Changzheng Hospital, Shanghai 200003, China

Huadong Hospital, Shanghai 200040, China

Huashan, Shanghai 200040, China

Renji Hospital, Shanghai 200001, China

Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai 200025, China

Shanghai 10th People's Hospital, Shanghai 200072, China

Shanghai 1st People's Hospital, Shanghai 200080, China

Shanghai 455 Hospital, Shanghai 200052, China

Shanghai 6th people's hospital, Shanghai 200233, China

Shanghai 85 Hospital, Shanghai 200052, China

Shanghai 9th People's Hospital, Shanghai 200011, China

Shanghai Changning District Centre Hospital, Shanghai 200336, China

Shanghai East Hospital, Shanghai 200120, China

Shanghai Yangpu District Centre Hospital, Shanghai 200090, China

Tongji Hospital, Shanghai 200065, China

Xinhua Hospital, Shanghai 200092, China

Zhongshan Hospital, Shanghai 200032, China

Taizhou People's Hospital, Taizhou, Jiangsu 225300, China

Guangxing Hospital, Hangzhou, Zhejiang 310007, China

Shaoyifu Hospital, Hangzhou, Zhejiang 310016, China

The 1st Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, Zhejiang 310003, China

Ningbo Lihuili Hospital, Ningbo, Zhejiang 315000, China

Wenling 1st People's Hospital, Wenling, Zhejiang 317500, China

The First affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang 325000, China

Xiangshan People's Hospital, Xiangshan, Zhejiang 315700, China

Starting date: September 2004
Last updated: November 29, 2007