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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name