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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002143
Receipt No. R000002564
Scientific Title COmbination Strategy on renal function of the benidipine or diuretics treatMent with RAS inhibitOrs in CKD hypertensive population
Date of disclosure of the study information 2009/07/01
Last modified on 2011/06/13

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Basic information
Public title COmbination Strategy on renal function of the benidipine or diuretics treatMent with RAS inhibitOrs in CKD hypertensive population
Acronym COmbination Strategy on renal function of the benidipine or diuretics treatMent with RAS inhibitOrs in CKD hypertensive population (COSMO-CKD)
Scientific Title COmbination Strategy on renal function of the benidipine or diuretics treatMent with RAS inhibitOrs in CKD hypertensive population
Scientific Title:Acronym COmbination Strategy on renal function of the benidipine or diuretics treatMent with RAS inhibitOrs in CKD hypertensive population (COSMO-CKD)
Region
Japan

Condition
Condition Hypertensive patients with albuminuria under the treatment of the inhibitor of the renin-angiotension system (RAS)
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the antialbuminuric effect between L/T-type calcium channel blocker (CCB) benidipine (4 to 8 mg/day) and thiazide diuretic hydrochlorthiazide (6.25 to 12.5 mg/day) as addition of RAS inhibitor in hypertensive patients with CKD
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes in urinary albumin/ creatinine(Cr) ratio in spot urine from pretreatment period (average of 2 measured value) to 12 months of treatment
Key secondary outcomes 1. Urinary albumin/Cr ratio in fspot urine: Percent changes from pretreatment period to each period of treatment, etc.
2. Estimated glomerular filtration rate (eGFR) calculated using the modified MDRD formula in the Japanese Society of Nephrology: eGFR (ml/min/1.73 m2) = 194 x age -0.287 x serum Cr - 1.094 (multiply by 0.739 in female)
3. Urinary liver-type free fatty acid-binding protein (L-FABP)
4. Serum Cr
5. Blood urea nitrogen (BUN)
6. Office blood pressure (BP)
7. Pulse rate
8. Renal events: Start of dialysis, renal transplantation
9. Cerebro-cardio-vascular events: Cerebro-cardio-vascular death (fatal myocardial infarction, fatal heart failure, sudden death, fatal stroke, other cardiovascular death) and hospitalization due to cerebro-cardio-vascular disease (nonfatal myocardial infarction, angina, heart failure, cerebral bleeding, cerebral infarction, transient cerebral ischemic attack)

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Benidipine (4 to 8 mg/day) is added in patients with the treatment of the RAS inhibitor.
If BP does not reach to lower than 130/80 mmHg, other antihypertensive drug than CCB, diuretic and RAS inhibitor is added.
Interventions/Control_2 Hydrochlorthiazide (6.25 to 12.5 mg/day) is added in patients with the treatment of the RAS inhibitor.
If BP does not reach to lower than 130/80 mmHg, other antihypertensive drug than CCB, diuretic and RAS inhibitor is added.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients to fulfill all the following condition at the start of the study can participate
1. Outpatient systolic BP is equal or more than130 mmHg and/or outpatient diastolic BP is equal or more than 80 mmHg.
2. Urinary albumin/Cr ratio at pretreatment period (average of 2 measured value) is equal or more than 300 mg/g
3. eGFR is equal or more than 30 mL/min/1.73m2.
4. Age is equal or more than 20 and less than 80 year-old
5. RAS inhibitor has been administered for more than 3 months and CCB and diuretic heve not been given within 3 months
6. Written informed consent is obtained based on written and oral explanation of physician in charge
Key exclusion criteria Patients who apply any of the flowing condition cannot participate
1. Outpatient systolic BP is equal or more than 180 mmHg and/or outpatient diastolic BP is equal or more than 110 mmHg. Or hypertensive emergency that requires intravenous administration of antihypertensives
2. Administration of adrenocorticosteroidal drug, immunosuppressant or long-term (equal or more than 2 weeks) administration of non-steroid anti-inflammatory drugs (NSAID)
3. Past history of severe side effect of CCB, thiazide diretic, ARB or ACE inhibitor
4. Type 1 diabetes and type 2 diabetes required hospitalization due to high hemoglobin A1c (equal and more than 9.0%), extremely high blood glucose, or diabetic ketoacidosis
5. Cerebrovascular disease occurs within 6 months
6. Sever heart failure (NYHA class is equal or more than III), severe arrhythmia (frequent ventricular or atrial extrasystole, prolonged ventricular tachycardia, atrial tachyrhythmia with severe tachycardia, atrial fibrillation or flutter with severe tachycardia, sick sinus syndrome with severe bradycardia, atrio-ventricular block with severe bradycardia), angina, or myocardial infarction within 6 months
7. AST or ALT is more than 5 times higher upper limits
8. Pregnant, possible to be pregnant, or willing to be pregnant
9. Patients who are inadequate by determination of physician in charge
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiro Fujita
Organization University of Tokyo Graduste School of Medicine
Division name Department of Nephrology and Endocrinology
Zip code
Address 7-3-1 Hongo,Bunkyo-ku,Tokyo 113-8655, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyuki Ando
Organization University of Tokyo Graduste School of Medicine
Division name Division of Molecular Cardiovascular Metabolism
Zip code
Address 7-3-1 Hongo,Bunkyo-ku,Tokyo 113-8655Japan
TEL 03-5800-9119
Homepage URL
Email Katsua-tky@umin.sc.jp

Sponsor
Institute COSMO-CKD Study Group
Institute
Department

Funding Source
Organization The Kidney Foundation of Japan Inc.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Enrolling by invitation
Date of protocol fixation
2009 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2013 Year 03 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 06 Month 30 Day
Last modified on
2011 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002564

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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