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

Shanghai Municipal Health Bureau

Status: Unknown

Conditions: Angiotensin II Type 1 Receptor Blockers; Proteinuria; Angiotensin-Converting Enzyme Inhibitors; Chronic Kidney Insufficiency

Treatments: Drug: Fosinopril and Losartan

Study type: Interventional

Funder types: Other

Identifiers

NCT00565396

2003ZD002

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 4 patient groups

1

Active Comparator group

Description:

Fosinopril 10mg/day(oral)

Treatment:

Drug: Fosinopril and Losartan

2

Active Comparator group

Description:

Fosinopril 20mg/day(oral)

Treatment:

Drug: Fosinopril and Losartan

3

Active Comparator group

Description:

Losartan 50mg/day(oral)

Treatment:

Drug: Fosinopril and Losartan

4

Active Comparator group

Description:

Losartan 100mg/day(oral)

Treatment:

Drug: Fosinopril and Losartan