UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of combination therapy of angiotensin II receptor blocker (ARB) and diuretic in hypertensive patients with chronic kidney disease (CKD)
Title of the study (Brief title)	Combined ARB And Thiazide in CKD Treatment Study
Region	Japan

Condition
Condition	Hypertension
Classification by specialty	Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The results of the GUARD study have shown that a combination drug of an ACE inhibitor and a low-dose diuretic decreased albuminuria in CKD patients, suggesting the beneficial effect of the combination in those patients. The present study aims to evaluate the efficacy of a drug with similar mechanisms, a combination drug of an ARB and a low-dose diuretic, in light of antihypertensive efficacy and effects on albuminuria / renal function and metabolism in hypertensive patients with CKD, in order to establish a new therapeutic strategy for those patient populations.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	Change and % change in blood pressure after 3 months of treatment
Key secondary outcomes	- Change and % change in blood pressure after 1 and 6 months of treatment - Change and % change in eGFR, urinary albumin excretion, serum uric acid, BNP, urinary 8OHdG and urinary Ngal after 3 and 6 months of treatment

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Losartan / HCTZ group
Interventions/Control_2
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	Inclusion criteria: 1) Patients with hypertension, who have been previously treated with monotherapy of a standard-dose of an ARB for more than 2 months, however, whose blood pressure has not been adequately controlled (systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90mmHg) 2) Patients with CKD of stage I - IV 3) Men and women aged 20 years or older 4) Outpatients 5) Patients who fully understand the study procedures explained to them using explanatory notes and have given written informed consent to participate in the study
Key exclusion criteria	Exclusion criteria: 1) Patients with uncontrolled hypertension (DBP >= 110mmHg) 2) Patients with malignant hypertension 3) Patients with uncontrolled diabetes (HbA1c >= 8.0%) and patients under insulin treatment 4) Patients who have stroke, AMI and/or critical vascular complications that required hospitalization within 6 months prior to the intervention 5) Patients with liver dysfunction [GPT(ALT) over three times the normal value] 6) Patients with critical renal failure (serum creatinine >= 3.0 mg/dL) 7) Patients with a previous history of gout attack or uncontrolled hyperuricemia (UA >= 9.0mg/dL) 8) Pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period 9) Patients with uncontrolled arrhythmia 10) Patients with cardiac insufficiency (NYHA grade III or IV) 11) Patients with a history of hypersensitivity to ingredients of losartan 12) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics 13) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size	30

Research contact person
Name of lead principal investigator	Masashi Mukoyama
Organization	Kyoto University Hospital
Division name	Department of Medicine and Clinical Science
Address	54 Shogoin kawahara-cho,Sakyo-ku,Kyoto
TEL	075-751-4420
Email	muko@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Hideki Yokoi
Organization	Kyoto University Hospital
Division name	Department of Medicine and Clinical Science
Address	54 Shogoin kawahara-cho,Sakyo-ku,Kyoto
TEL	075-751-4420
Homepage URL
Email	yokoih@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital
Institute
Department

Funding Source
Organization	Kyoto University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	京都大学医学部附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2010 Year 07 Month 16 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 07 Month 02 Day
Anticipated trial start date	2010 Year 09 Month 01 Day
Last follow-up date	2012 Year 09 Month 01 Day
Date of closure to data entry	2014 Year 03 Month 31 Day
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	2010 Year 07 Month 16 Day
Last modified on	2018 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004711