UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010170 |
|---|---|
| Receipt number | R000010876 |
| Scientific Title | 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 - |
| Date of disclosure of the study information | 2013/03/05 |
| Last modified on | 2016/09/29 11:13:08 |
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Basic information
Public title
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 -
Acronym
Intermittent removal of thiazide diuretics for treatment of hypertension in CKD patients study (INTERVAL study)
Scientific Title
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 -
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shunya Uchida |
Organization
Teikyo University School of Medicine
Division name
Department of Internal Medcine
Zip code
Address
11-1, Kaga 2-chome, Itabashi-ku, Teikyo, Japan
TEL
03-3964-1211
uchidashunya@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunya Uchida |
Organization
Teikyo University School of Medicine
Division name
Department of Internal Medcine
Zip code
Address
11-1, Kaga 2-chome, Itabashi-ku, Teikyo, Japan
TEL
03-3964-1211
Homepage URL
uchidasyunya@gmail.com
Sponsor or person
Institute
Department of Internal Medcine, Teikyo University School of Medicine
Institute
Department
Personal name
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)
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
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 |
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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 07 | Month | 12 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010876
