UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030932 |
|---|---|
| Receipt number | R000035254 |
| Scientific Title | Optimal treatment strategy of mineralocorticoid receptor antagonists for primary aldosteronism |
| Date of disclosure of the study information | 2018/01/23 |
| Last modified on | 2021/08/12 21:10:21 |
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Basic information
Public title
Optimal treatment strategy of mineralocorticoid receptor antagonists for primary aldosteronism
Acronym
Optimal treatment strategy of mineralocorticoid receptor antagonists for primary aldosteronism
Scientific Title
Optimal treatment strategy of mineralocorticoid receptor antagonists for primary aldosteronism
Scientific Title:Acronym
Optimal treatment strategy of mineralocorticoid receptor antagonists for primary aldosteronism
Region
| Japan |
Condition
Condition
Primary aldosteronism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate optimal treatment strategy of mineralocorticoid receptor antagonists for primary aldosteronism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure
Urinary albumin
Key secondary outcomes
QOL
eGFR
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
Increase the dose of mineralocorticoid receptor antagonists (MRA) until serum K value reach to normal upper limit (serum K level 4.6-5.0 mEq/L) during 6 months visit (every 4-8 weeks). Basically not changing other antihypertention drugs. If the serum K value is less than 4.5mEq/L, increase MRA 25-50mg. If it is 4.6-5.0mEq/L, maintain at the same amount. If it is 5.1-5.4mEq/L, consider to decrease. If it is more than 5.5mEq/L, must to decrease.
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
Patients visiting our hospital with primary aldosteronism who agreed to participate in this study. Patients whoes systolic blood pressure is control under 200mmHg and diastolic blood pressure under 120mmHg.
Key exclusion criteria
Patients who did not agree to this study, receiving sex hormone therapy, having heart diseases (NYHA 3 degree or higher), liver dysfunction (AST/ALT over 100IU/mL or T-Bil over 2.0mg/dL), renal dysfunction (Cr over 2.0mg/dL), serious diseases such as malignant diseases and judged inappropriate.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Otsuki |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
565-0871
Address
2-2 Yamada-oka. Suita, Osaka, Japan
TEL
06-6879-3732
otsuki@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Saiki |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
565-0871
Address
2-2 Yamada-oka. Suita, Osaka, Japan
TEL
06-6879-3732
Homepage URL
saiki-a@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2 Yamada-oka. Suita, Osaka, Japan
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 22 | Day |
Last modified on
| 2021 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035254
