UMIN-CTR Clinical Trial

Basic information
Public title	Renoprotective effect of Calcium channel blocker or Diuretics treatment with Renin-Angiotensin system(RAS) inhibitor in hypertensive patients with chronic kidney disease(CKD) (CD Study)
Acronym	CD Study
Scientific Title	Renoprotective effect of Calcium channel blocker or Diuretics treatment with Renin-Angiotensin system(RAS) inhibitor in hypertensive patients with chronic kidney disease(CKD) (CD Study)
Scientific Title:Acronym	CD Study
Region	Japan

Condition
Condition	Hypertensive patients with CKD under the treatment of the inhibitor of the renin-angiotensin 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 long acting calcium channel blocker(CCB) azelnidipine (8 to 16 mg/day) and thiazide diuretic trichlormethiazide (0.5 to 1 mg/day) as addition of RAS inhibitor in hypertensive patients with CKD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in urinary albumin/creatinine(Alb/Cr) ratio in early morning samples from pretreatment period to 12 months of treatment
Key secondary outcomes	1. blood pressure(Office, Home) 2. Pulse rate(Home) 3. Change in the urinary Alb/Cr ratio 4. Change in eGFR 5. Relationship between BMI and BP/urinary Alb/Cr ratio 6. Change in HbA1c levels 7. Change in urinary excretion of sodium 8. Change in serum uric acid 9. Change in urinary megalin and urine podocalyxin 10. Cerebro-cardio-vascular events

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 considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Azelnidipine(8 to 16mg/day) is added in patients with the treatment of the RAS inhibitor.If BP dose not reach to lower than 130/80mmHg, other antihypertensive drug except CCB, diuretic and RAS inhibitor is added.
Interventions/Control_2	Trichlormethiazide(0.5 to 1mg/day) is added in patients with the treatment of the RAS inhibitor. If BP dose not reach to lower than 130/80mmHg, other antihypertensive drug except 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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Outpatients to fulfill all the following condition can participate 1) Outpatient systolic BP is equal or more than 130 and less than 180 and/or outpatient diastolic BP is equal or more than 85 and less than 110 mmHg. 2) Outpatients with CKD 3) eGFR is more than 30 mL/min/1.73m2. 4) Age is equal or more than 20 and less than 85 year-old. 5) RAS inhibitor has been administered for more than 3 months and CCB and diureteic have 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	1) Secondary hypertension or malignant hypertension(within hypertension in level 3) 2) Severe heart failure(NYHA Class is equal or more than III) 3) Atrial fibrillation or flutter with severe arrhythmia 4) Severe renal failure or liver failure(patient on dialysis, AST or ALT is more than 5 times higher upper limits) 5) Not appropriate for change to the test drugs from current therapy for coronary disease(i.e. CCB, diuretics, etc.) 6) Patient with severe adverse effects by RAS inhibitor, CCB and diuretic 7) Patient has merged the disease seems to be bad, such as malignant tumor prognosis. 8) 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. 9) Patients already used other CCB or a diuretic. 10) Pregnant, possible to be pregnant, or willing to be pregnant 11) Patients who are inadequate by determination of physician in charge
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ichiei Narita
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Clinical Nephrology and Rheumatology
Zip code
Address	1-757 Asahimachi-dori, chuo-ku,Niigata 951-8510, Japan
TEL	025-227-2200
Email	naritai@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Emiko Kouno
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Clinical Nephrology and Rheumatology
Zip code
Address	1-757 Asahimachi-dori, chuo-ku,Niigata 951-8510, Japan
TEL	025-227-2200
Homepage URL
Email	e-kouno@med.niigata-u.ac.jp

Sponsor
Institute	Niigata University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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IRB Contact (For public release)
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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	青柳医院（新潟県）、五十嵐医院（新潟県）、岡田内科医院（新潟県）、きくち内科医院（新潟県）、岡田内科医院（新潟県）、井上内科医院（新潟県）、前田内科医院（新潟県） 、安田診療所（新潟県）、ほしの医院（新潟県）、筒井内科クリニック（新潟県）、東新潟病院（新潟県）、林内科クリニック（新潟県）、中新潟クリニック（新潟県）、笹川医院（新潟県）、花野内科医院（新潟県）、田邊医院（新潟県）、新潟県立津川病院（新潟県）、下越病院（新潟県）、阿賀町上川診療所（新潟県）、豊栄病院（新潟県）、えきまえクリニック　内科はやし医院（新潟県）、わかばやし内科クリニック（新潟県）、済生会新潟第二病院（新潟県）、木戸病院（新潟県）水原郷病院（新潟県）、こばりファミリークリニック（新潟県）、三浦クリニック（新潟県）、新潟医療センター病院（新潟県）

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Results Delayed
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Baseline Characteristics
Participant flow
Adverse events
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Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2013 Year 05 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	2010 Year 09 Month 30 Day
Last modified on	2013 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005160

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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