UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001643 |
|---|---|
| Receipt number | 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 18:57:38 |
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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
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
Sponsor or person
Institute
Kyushu University Hospital Kidney Care Unit
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001975
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
