UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000804 |
|---|---|
| Receipt number | R000000962 |
| Scientific Title | Home blood pressure for diabetic nephropathy |
| Date of disclosure of the study information | 2007/09/01 |
| Last modified on | 2018/10/03 16:01:28 |
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Basic information
Public title
Home blood pressure for diabetic nephropathy
Acronym
HBP-DN
Scientific Title
Home blood pressure for diabetic nephropathy
Scientific Title:Acronym
HBP-DN
Region
| Japan |
Condition
Condition
diabetic nephropathy
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of the target home blood pressure to induce remission of microalbuminuria with type 2 diabetics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
remission of microalbuminuria to normoalbuminuria
Key secondary outcomes
regression of microalbuminuria
progression of microalbuminuria
doubling of serum creatinine
endstage renaldisease
developement of ischemic heart disease
developement of cerebrovascular disease
death due to ischemic heart disease or cerebrovascular disease
death due to any cause
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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) type 2 diabetics
(2) microalbuminuric patients
(30 =< urinary albumin excretion < 300 mg/g Cr)
(3) HbA1c < 9.0%
Key exclusion criteria
(1) Pregnant
(2) Patients who can not measure home blood pressure
(3) Patients with orthostatic hypotension. Patients who suffered from cerebrovascular disease in a year.
(4) Patients with urinary tract infection. Patients with congestive heart disease. Patients with neurogenic bladder. Patients with glomerulonephritis.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motonobu Nishimura |
Organization
National Hospital Organization Chiba-east National Hospital
Division name
Department of Internal Medicine
Zip code
Address
673, Nitonatyou, Tyuuou-ku, Chiba city, Chiba, 260-8712, Japan
TEL
043-261-5171
mnishi02@cehpnet.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Tanaka |
Organization
National Hospital Organization Chiba-east National Hospital
Division name
Clinical Reseach Center
Zip code
Address
673, Nitonatyou, Tyuuou-ku, Chiba city, Chiba, 260-8712, Japan
TEL
043-261-5171
Homepage URL
k-tanaka@cehpnet.com
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
国立病院機構函館病院（北海道）、国立病院機構旭川医療センター（北海道）、国立病院機構水戸医療センター（茨城県）、国立病院機構埼玉病院（埼玉県）、国立病院機構東埼玉病院（埼玉県）、国立病院機構千葉医療センター（千葉県）、国立病院機構千葉東病院（千葉県）、国立病院機構下志津病院（千葉県）、国立病院機構災害医療センター（東京都）、国立病院機構横浜医療センター（神奈川）、国立病院機構久里浜医療センター（神奈川）、国立病院機構名古屋医療センター（愛知県）、国立病院機構福井病院（福井県）、国立病院機構三重中央医療センター（三重県）、国立病院機構京都医療センター（京都府）、国立病院機構大阪医療センター（大阪府）、国立病院機構大阪南医療センター（大阪府）、国立病院機構兵庫中央病院（兵庫県）、国立病院機構浜田医療センター（島根県）、国立病院機構岡山医療センター（岡山県）、国立病院機構東徳島医療センター（徳島県）、国立病院機構徳島病院（徳島県）、国立病院機構四国こどもとおとなの医療センター（香川県）、国立病院機構愛媛病院（愛媛県）、国立病院機構九州医療センター（福岡県）、国立病院機構熊本医療センター（熊本県）、国立病院機構鹿児島医療センター（鹿児島県）、国立病院機構嬉野医療センター（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 09 | Month | 01 | 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
Optimal home systolic blood pressure for the induction of remission/regression of microalbuminuria might be below 130 mmHg. It is required to confirm whether keeping home systolic blood pressure below 130mmHg leads to subsequent renoprotection or not.
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
Main results already published
Date of protocol fixation
| 2007 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 31 | Day |
Other
Other related information
Blood pressure of microalbuminuric diabetic patients is controlled measuring home blood pressure. Patients will be divided into several groups according to the achieved home blood pressure. Incidence of endpoints will be compared between groups.
Management information
Registered date
| 2007 | Year | 08 | Month | 18 | Day |
Last modified on
| 2018 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000962
| Research Plan | |
|---|---|
| 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 |
