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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001643
Receipt No. R000001975
Scientific Title Trial of Proteinuria Reduction Effect of Losartan/Hydrochlorothiazide Therapy to Chronic Kidney Disease with Hypertension
Date of disclosure of the study information 2009/01/19
Last modified on 2013/01/09

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Basic information
Public title Trial of Proteinuria Reduction Effect of Losartan/Hydrochlorothiazide Therapy to Chronic Kidney Disease with Hypertension
Acronym Trial of Proteinuria Reduction Effect of Losartan/Hydrochlorothiazide to CKD patients
Scientific Title Trial of Proteinuria Reduction Effect of Losartan/Hydrochlorothiazide Therapy to Chronic Kidney Disease with Hypertension
Scientific Title:Acronym Trial of Proteinuria Reduction Effect of Losartan/Hydrochlorothiazide to CKD patients
Region
Japan

Condition
Condition Chronic kidney disease patients with hypertension
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the proteinuria reduction effect of losartan/hydrochlorothiazide on chronic kidney disease patients with hypertension.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary end point is change in the Up:Ucr ratio from baseline to month 12.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ARB/hydrochlorothiazide combination drug
Interventions/Control_2 ARB
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.All patients have hypertension (sBP >130, dBP >80)
2.All patients fulfilled the inclusion criteria of a stable proteinuria Up/Ucr >0.3.
3.All patients have CKD, and eGFR >15mL/min/1.73m2.
4. Age between 20 and 75yr are included.
Key exclusion criteria Patients with uncontrolled hypertension, serum patassium >5.5 mEq/L, cardiovascular disease (myocardial infarction, unstable angina, stroke within last 3 months), pregnancy,lactation,nephrotic syndrome (serum Alb <2g/dl), frequent users of diuretics are excluded.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Tsuruya
Organization Kyushu University
Division name Department of integrated therapy for chronic kidney disease graduate school of medical sciences
Zip code
Address 3-1-1 Maidashi, higashi-ku Fukuoka
TEL 092-642-5843
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kiichiro Fujisaki
Organization Kyushu University Hospital
Division name Kidney Care Unit
Zip code
Address 3-1-1 Maidashi, higashi-ku Fukuoka
TEL 092-642-5843
Homepage URL
Email

Sponsor
Institute Kyushu University Hospital Kidney Care Unit
Institute
Department

Funding Source
Organization no fundation
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 01 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2012 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 01 Month 16 Day
Last modified on
2013 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001975

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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