UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003919 |
|---|---|
| Receipt number | 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 23:09:22 |
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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
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
yokoih@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004711
