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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Shanghai Municipal Health Bureau.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shanghai Municipal Health Bureau
ClinicalTrials.gov Identifier:
NCT00565396
First received: November 28, 2007
Last updated: November 29, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention
Chronic Kidney Insufficiency
Angiotensin-Converting Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Proteinuria
Drug: Fosinopril and Losartan

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center,Double-Blind,Randomized,Controlled Clinical Trial of Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3

Resource links provided by NLM:


Further study details as provided by Shanghai Municipal Health Bureau:

Primary Outcome Measures:
  • progress to End Stage Renal Disease [ Time Frame: within two years ] [ Designated as safety issue: Yes ]
  • double of serum creatinine [ Time Frame: within two years ] [ Designated as safety issue: Yes ]
  • all cause mortality [ Time Frame: within two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • decreased proteinuria [ Time Frame: within two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: September 2004
Estimated Study Completion Date: July 2008
Arms Assigned Interventions
Active Comparator: 1
Fosinopril 10mg/day(oral)
Drug: Fosinopril and Losartan
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
Active Comparator: 2
Fosinopril 20mg/day(oral)
Drug: Fosinopril and Losartan
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
Active Comparator: 3
Losartan 50mg/day(oral)
Drug: Fosinopril and Losartan
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
Active Comparator: 4
Losartan 100mg/day(oral)
Drug: Fosinopril and Losartan
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565396

Locations
China, Jiangsu
Taizhou People's Hospital
Taizhou, Jiangsu, China, 225300
China, Zhejiang
Shaoyifu Hospital
Hangzhou, Zhejiang, China, 310016
The 1st Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Guangxing Hospital
Hangzhou, Zhejiang, China, 310007
Ningbo Lihuili Hospital
Ningbo, Zhejiang, China, 315000
Wenling 1st People's Hospital
Wenling, Zhejiang, China, 317500
The First affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China, 325000
Xiangshan People's Hospital
Xiangshan, Zhejiang, China, 315700
China
Shanghai 85 Hospital
Shanghai, China, 200052
Huashan
Shanghai, China, 200040
Shanghai 1st People's Hospital
Shanghai, China, 200080
Huadong Hospital
Shanghai, China, 200040
Shanghai East Hospital
Shanghai, China, 200120
Shanghai Changning District Centre Hospital
Shanghai, China, 200336
Shanghai Yangpu District Centre Hospital
Shanghai, China, 200090
Shanghai 10th People's Hospital
Shanghai, China, 200072
Tongji Hospital
Shanghai, China, 200065
Shanghai 9th People's Hospital
Shanghai, China, 200011
Renji Hospital
Shanghai, China, 200001
Xinhua Hospital
Shanghai, China, 200092
Shanghai 6th people's hospital
Shanghai, China, 200233
Zhongshan Hospital
Shanghai, China, 200032
Changzheng Hospital
Shanghai, China, 200003
Changhai Hospital
Shanghai, China, 200433
Shanghai 455 Hospital
Shanghai, China, 200052
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Municipal Health Bureau
Investigators
Study Chair: Nan Chen, M.D. Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
  More Information

No publications provided

Responsible Party: Nan Chen, Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
ClinicalTrials.gov Identifier: NCT00565396     History of Changes
Other Study ID Numbers: 2003ZD002, 2003ZD002
Study First Received: November 28, 2007
Last Updated: November 29, 2007
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Proteinuria
Renal Insufficiency
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Fosinopril
Losartan
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on April 17, 2014