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

Sponsor:	Shanghai Municipal Health Bureau
Information provided by:	Shanghai Municipal Health Bureau
ClinicalTrials.gov Identifier:	NCT00565396

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
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:

Drug Information available for: Fosinopril sodium Fosinopril Losartan Losartan potassium

U.S. FDA Resources

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
1: Active Comparator Fosinopril 10mg/day(oral)	Drug: Fosinopril and Losartan Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
2: Active Comparator Fosinopril 20mg/day(oral)	Drug: Fosinopril and Losartan Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
3: Active Comparator Losartan 50mg/day(oral)	Drug: Fosinopril and Losartan Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
4: Active Comparator 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
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, China, 200025
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
Shanghai East Hospital
Shanghai, China, 200120
Shanghai 455 Hospital
Shanghai, China, 200052
Shanghai 85 Hospital
Shanghai, China, 200052
Huashan
Shanghai, China, 200040
Shanghai 1st People's Hospital
Shanghai, China, 200080
Huadong Hospital
Shanghai, China, 200040
Changhai Hospital
Shanghai, China, 200433
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
China, Jiangsu
Taizhou People's Hospital
Taizhou, Jiangsu, China, 225300
China, Zhejiang
The First affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China, 325000
Xiangshan People's Hospital
Xiangshan, Zhejiang, China, 315700
Ningbo Lihuili Hospital
Ningbo, Zhejiang, China, 315000
Wenling 1st People's Hospital
Wenling, Zhejiang, China, 317500
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

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

Additional relevant MeSH terms:

Renal Insufficiency
Fosinopril
Losartan
Molecular Mechanisms of Pharmacological Action
Urination Disorders
Kidney Failure, Chronic
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

Angiotensin II Type 1 Receptor Blockers
Urological Manifestations
Signs and Symptoms
Proteinuria
Urologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Anti-Arrhythmia Agents
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on February 08, 2010