UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Studies on the antihypertensive effect and uric acid metabolism by the combination therapy of ARB and diuretics in the CKD patients with hypertension - Comparison between daily and alternate-daily medication of diuretics -
Title of the study (Brief title)	Intermittent removal of thiazide diuretics for treatment of hypertension in CKD patients study (INTERVAL study)
Region	Japan

Condition
Condition	The CKD patients with hypertension
Classification by specialty	Medicine in general Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the antihypertensive effects and the influences on some metabolic systems by the daily and alternate-daily combination medication of a thiazide diuretics, trichlormethiazide in the CKD patients with hypertension whose blood pressures have not yet achieved the target BP level by an ARB, irbesartan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Change of blood pressure (office blood pressure, home blood pressure) 2. Changes of serum uric acid level
Key secondary outcomes	1. Changes in renal function (serum creatinine, eGFR, serum cystatin C et al.) 2. Changes in urinary examinations (urine protein et al.) 3. Changes of metabolic biomarkers (lipids, glucose and electrolytes) 4. Changes of heart rate

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Daily administration of irbesartan 100mg with trichrolmethiazide 0.5-1mg
Interventions/Control_2	Administration of irbesartan 100mg daily with tricholmethiazide 1-2mg every other day
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Chronic kidney disease 2) Patients without acute changes in renal function and with stability in general condition 3) Hypertensive patients during treatment with antihypertensive drugs, or hypertensive patients whose blood pressures have not achieved to the targeted level recommended by "CKD guideline 2012" 4) Patients over the age of 20, unquestioned gender 5) The patients who we can obtain the informed consent signed by themselves.
Key exclusion criteria	1) The patient with contraindication of irbesartan medication 1. Patients with a history of hypersensitivity to any component of this drug 2. Patients during pregnancy and with pregnant possibility 2) The patient with contraindication of the trichrolmethiazide medication 1. Patients with anuria 2. Patients with acute renal failure 3. Patients with hyponatremia, and hypokalemia 4. Patients with a history of hypersensitivity to thiazides or analogues 3) Patients who are judged ineligible for any other reasons by the investigator
Target sample size	50

Research contact person
Name of lead principal investigator	Shunya Uchida
Organization	Teikyo University School of Medicine
Division name	Department of Internal Medcine
Address	11-1, Kaga 2-chome, Itabashi-ku, Teikyo, Japan
TEL	03-3964-1211
Email	uchidashunya@gmail.com

Public contact
Name of contact person	Shunya Uchida
Organization	Teikyo University School of Medicine
Division name	Department of Internal Medcine
Address	11-1, Kaga 2-chome, Itabashi-ku, Teikyo, Japan
TEL	03-3964-1211
Homepage URL
Email	uchidasyunya@gmail.com

Sponsor
Institute	Department of Internal Medcine, Teikyo University School of Medicine
Institute
Department

Funding Source
Organization	Department of Internal Medcine, Teikyo University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	帝京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 05 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 07 Month 12 Day
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 03 Month 05 Day
Last modified on	2016 Year 09 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010876