UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052937 |
|---|---|
| Receipt number | R000060401 |
| Scientific Title | Optimal antithyroid medication dosage reduction for patients with moderate to severe Graves' disease |
| Date of disclosure of the study information | 2023/11/29 |
| Last modified on | 2023/11/29 00:16:04 |
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Basic information
Public title
Optimal antithyroid medication dosage reduction for patients with moderate to severe Graves' disease
Acronym
Optimal antithyroid medication dosage reduction for patients with moderate to severe Graves' disease
Scientific Title
Optimal antithyroid medication dosage reduction for patients with moderate to severe Graves' disease
Scientific Title:Acronym
Optimal antithyroid medication dosage reduction for patients with moderate to severe Graves' disease
Region
| Japan |
Condition
Condition
Graves' disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the appropriate weight loss strategy for patients with moderate to severe Graves' disease treated with two thyroid suppressing medications (Mercazole and Potassium Iodide) to ensure that thyroid function does not worsen during the reduction of therapeutic dosage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint: Relapse of thyrotoxicosis during and after discontinuation of dose reduction
Secondary endpoints: percent change in thyroid volume, percent change in TRAb titer, remission rate at 2 years
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with moderate to severe Graves' disease (blood FT4 level above 5.0 ng/dL) who started treatment with MMI 15 mg + KI 50 mg, then reduced the dose from MMI.
Interventions/Control_2
Patients with moderate to severe Graves' disease (blood FT4 level above 5.0 ng/dL) who started treatment with MMI 15 mg + KI 50 mg, then reduced the dose from KI.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with untreated Graves' disease who plan to attend the facilities participating in this study will be eligible.
(1) Patients who are between 18 and 80 years of age at the time of consent.
(2) Patients with a confirmed diagnosis of moderate to severe Graves' disease (blood FT4 above 5.0 ng/dL) and who will start treatment with MMI 15 mg + KI 50 mg.
(3) Patients who have received a thorough explanation of their participation in this study, and who have given written consent of their own free will based on sufficient understanding.
Key exclusion criteria
Patients with untreated Graves' disease who plan to attend a facility participating in this study will be included.
(1) Pregnant women, lactating women, and patients who plan to become pregnant within 2 years
(2) Patients with untreated Graves' disease who may have thyroid crisis
(3) Patients who have received curative treatment for Graves' disease (surgery, intra-iodine radioiodine therapy) in the past
(4) Patients receiving immunosuppressive therapy or drugs that affect thyroid function (amiodarone, lithium carbonate, immune checkpoint drugs)
(5) Other patients deemed inappropriate as research subjects by the principal investigator.
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Uchida |
| Middle name | |
| Last name | Toyoyoshi |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo, Tokyo, Japan
TEL
+81-3-5802-1579
uchitoyo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Uchida |
| Middle name | |
| Last name | Toyoyoshi |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo, Tokyo, Japan
TEL
+81-3-5802-1579
Homepage URL
uchitoyo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo, Tokyo, Japan
Tel
+81-3-5802-1584
hongo-rinri@juntendo.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
| 2023 | Year | 11 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 29 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060401
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