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

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ClinicalTrials.gov Identifier: NCT00565396
Recruitment Status : Unknown
Verified November 2007 by Shanghai Municipal Health Bureau.
Recruitment status was:  Active, not recruiting
First Posted : November 30, 2007
Last Update Posted : November 30, 2007
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Insufficiency Angiotensin-Converting Enzyme Inhibitors Angiotensin II Type 1 Receptor Blockers Proteinuria Drug: Fosinopril and Losartan Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2004
Estimated Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. progress to End Stage Renal Disease [ Time Frame: within two years ]
  2. double of serum creatinine [ Time Frame: within two years ]
  3. all cause mortality [ Time Frame: within two years ]

Secondary Outcome Measures :
  1. decreased proteinuria [ Time Frame: within two years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565396


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

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
First Posted: November 30, 2007    Key Record Dates
Last Update Posted: November 30, 2007
Last Verified: November 2007

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