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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004304 |
Receipt No. | R000005160 |
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) |
Date of disclosure of the study information | 2010/10/01 |
Last modified on | 2013/10/01 |
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 | |
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Condition | |||
Condition | Hypertensive patients with CKD under the treatment of the inhibitor of the renin-angiotensin system(RAS) | ||
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 300 |
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Name of lead principal investigator |
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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 | ||||||
naritai@med.niigata-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
e-kouno@med.niigata-u.ac.jp |
Sponsor | |
Institute | Niigata University |
Institute | |
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Funding Source | |
Organization | none |
Organization | |
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Category of Funding Organization | Self funding |
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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) |
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Date of disclosure of the study information |
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Publication of results | Unpublished |
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Recruitment status | Completed | ||||||
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Last modified on |
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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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