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

Email

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


Email

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


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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name