NCT00565396

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

26 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

November 30, 2007

Status Verified

November 1, 2007

First QC Date

November 28, 2007

Last Update Submit

November 29, 2007

Conditions

Chronic Kidney InsufficiencyAngiotensin-Converting Enzyme InhibitorsAngiotensin II Type 1 Receptor BlockersProteinuria

Outcome Measures

Primary Outcomes (3)

  • progress to End Stage Renal Disease

    within two years

  • double of serum creatinine

    within two years

  • all cause mortality

    within two years

Secondary Outcomes (1)

  • decreased proteinuria

    within two years

Study Arms (4)

1

ACTIVE COMPARATOR

Fosinopril 10mg/day(oral)

Drug: Fosinopril and Losartan

2

ACTIVE COMPARATOR

Fosinopril 20mg/day(oral)

Drug: Fosinopril and Losartan

3

ACTIVE COMPARATOR

Losartan 50mg/day(oral)

Drug: Fosinopril and Losartan

4

ACTIVE COMPARATOR

Losartan 100mg/day(oral)

Drug: Fosinopril and Losartan

Interventions

Fosinopril and LosartanDRUG

Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)

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Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Taizhou People's Hospital

Taizhou, Jiangsu, 225300, China

Location

The 1st Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Guangxing Hospital

Hangzhou, Zhejiang, 310007, China

Location

Shaoyifu Hospital

Hangzhou, Zhejiang, 310016, China

Location

Ningbo Lihuili Hospital

Ningbo, Zhejiang, 315000, China

Location

Wenling 1st People's Hospital

Wenling, Zhejiang, 317500, China

Location

The First affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

Location

Xiangshan People's Hospital

Xiangshan, Zhejiang, 315700, China

Location

Renji Hospital

Shanghai, 200001, China

Location

Changzheng Hospital

Shanghai, 200003, China

Location

Shanghai 9th People's Hospital

Shanghai, 200011, China

Location

Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, 200025, China

Location

Zhongshan Hospital

Shanghai, 200032, China

Location

Huadong Hospital

Shanghai, 200040, China

Location

Huashan

Shanghai, 200040, China

Location

Shanghai 455 Hospital

Shanghai, 200052, China

Location

Shanghai 85 Hospital

Shanghai, 200052, China

Location

Tongji Hospital

Shanghai, 200065, China

Location

Shanghai 10th People's Hospital

Shanghai, 200072, China

Location

Shanghai 1st People's Hospital

Shanghai, 200080, China

Location

Shanghai Yangpu District Centre Hospital

Shanghai, 200090, China

Location

Xinhua Hospital

Shanghai, 200092, China

Location

Shanghai East Hospital

Shanghai, 200120, China

Location

Shanghai 6th people's hospital

Shanghai, 200233, China

Location

Shanghai Changning District Centre Hospital

Shanghai, 200336, China

Location

Changhai Hospital

Shanghai, 200433, China

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicProteinuria

Interventions

FosinoprilLosartan

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUrination DisordersUrological ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Phosphinic AcidsOrganophosphorus CompoundsOrganic ChemicalsProlineImino AcidsAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Nan Chen, M.D.

    Ruijin Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 28, 2007

First Posted

November 30, 2007

Study Start

September 1, 2004

Study Completion

July 1, 2008

Last Updated

November 30, 2007

Record last verified: 2007-11

Locations

CN(26)