UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002644 |
|---|---|
| Receipt number | R000001974 |
| Scientific Title | Clinical study of calcium channel blockers in patients with chronic kidney disease |
| Date of disclosure of the study information | 2009/10/25 |
| Last modified on | 2015/05/15 12:38:51 |
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Basic information
Public title
Clinical study of calcium channel blockers in patients with chronic kidney disease
Acronym
Clinical study of CCBs
Scientific Title
Clinical study of calcium channel blockers in patients with chronic kidney disease
Scientific Title:Acronym
Clinical study of CCBs
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of CCBs for patients with CKD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
renal function, urinary protein excretion, blood pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
benidipine
Interventions/Control_2
amlodipine
Interventions/Control_3
cilnidipine
Interventions/Control_4
azelnidipine
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)CKD stage 3-5
2)Hypertension; more than 130/80mmHg
3)Urinary protein/creatinine ratio; more than 300mg/gCr
Key exclusion criteria
1)hypertensive emergency; 2) history of severe heart failure, angina, myocardial infarction, or stroke within 6 months before the start of the trial; 3) previous treatment with steroids or immunosuppressants; 4) renovascular hypertension or endocrine hypertension; 5) severe diabetes mellitus that led to hospitalization because of extremely high plasma glucose or that was associated with complications such as diabetic ketoacidosis.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Abe |
Organization
Nihon University School of Medicine
Division name
Nephrology, Hypertension and Endocrinology
Zip code
Address
30-1, OyaguchiKamimachi, Itabashi-ku,Tokyo,Japan
TEL
03-3972-8111
mabe@med.nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Abe |
Organization
Nihon University Nerima Hikarigaoka Hospital
Division name
Internal medicine
Zip code
Address
2-11-1, Hikarigaoka, Nerima-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
mabe@med.nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Nerima Hikarigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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 | 10 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | 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 | 10 | Month | 19 | Day |
Last modified on
| 2015 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001974
