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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003919
Receipt No. R000004711
Scientific Title Efficacy of combination therapy of angiotensin II receptor blocker (ARB) and diuretic in hypertensive patients with chronic kidney disease (CKD)
Date of disclosure of the study information 2010/07/16
Last modified on 2018/04/17

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Basic information
Public title Efficacy of combination therapy of angiotensin II receptor blocker (ARB) and diuretic in hypertensive patients with chronic kidney disease (CKD)
Acronym Combined ARB And Thiazide in CKD Treatment Study
Scientific Title Efficacy of combination therapy of angiotensin II receptor blocker (ARB) and diuretic in hypertensive patients with chronic kidney disease (CKD)
Scientific Title:Acronym 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
1st name
Middle name
Last name Masashi Mukoyama
Organization Kyoto University Hospital
Division name Department of Medicine and Clinical Science
Zip code
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
1st name
Middle name
Last name Hideki Yokoi
Organization Kyoto University Hospital
Division name Department of Medicine and Clinical Science
Zip code
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)

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 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

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 Terminated
Date of protocol fixation
2010 Year 07 Month 02 Day
Date of IRB
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

Other
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

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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