UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052316 |
|---|---|
| Receipt number | R000059606 |
| Scientific Title | Association between posaconazole use and hypokalemia: A Systematic Review and Meta-Analysis |
| Date of disclosure of the study information | 2023/09/30 |
| Last modified on | 2024/09/26 11:25:54 |
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Basic information
Public title
Association between posaconazole use and hypokalemia: A Systematic Review and Meta-Analysis
Acronym
Association between posaconazole use and hypokalemia
Scientific Title
Association between posaconazole use and hypokalemia: A Systematic Review and Meta-Analysis
Scientific Title:Acronym
Association between posaconazole use and hypokalemia: A Systematic Review and Meta-Analysis
Region
| Japan |
Condition
Condition
Patients with prophylactic administration of posaconazole for invasive fungal infections in severely immunocompromised states such as hematopoietic stem cell transplantation or hematologic malignancies where neutropenia is predicted
Patients treated with posaconazole for aspergillosis, fusariosis, mucormycosis, coccidioidosis, chromoblastomycosis, and mycetoma
Patients treated with posaconazole for oropharyngeal candidiasis
The trial will be a randomised controlled trial with the above subjects
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the association between posaconazole use and hypokalemia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
hypokalemia
Key secondary outcomes
<Secondary outcomes>
rhabdomyolysis, pseudohyperaldosteronism, hypertension
<Subgroup Analysis>
(1) Prophylactic administration of posaconazole for invasive fungal infections in severe immunodeficiency states such as hematopoietic stem cell transplantation or hematologic malignancies where neutropenia is expected
(2) Fungal infections (invasive aspergillosis, fusariasis, mucormycosis, coccidioidosis, chromoblastomycosis, and mycetoma)
(3) Investigate with antifungal agents or placebo, respectively
Subgroup analysis will be performed in each of the above.
<Sensitivity analysis>
Meta-analysis will be performed by excluding trials with a risk of bias for "High" in ROB2.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 13 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with prophylactic administration of posaconazole for invasive fungal infections in severely immunocompromised states such as hematopoietic stem cell transplantation or hematologic malignancies where neutropenia is predicted
Patients treated with posaconazole for aspergillosis, fusariosis, mucormycosis, coccidioidosis, chromoblastomycosis, and mycetoma
Patients treated with posaconazole for oropharyngeal candidiasis
Key exclusion criteria
Letters/correspondence, case reports, relevant reviews, no controlled arm, unclear outcomes
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Nakano |
Organization
Saiseikai Futsukaichi Hospital
Division name
Department of pharmacy
Zip code
818-0058
Address
3-13-1, Yumachi, Chikushino City, Fukuoka
TEL
092-923-1551
y-nakano@saiseikai-futsukaichi.org
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nakano |
Organization
Saiseikai Futsukaichi Hospital
Division name
Department of pharmacy
Zip code
818-0058
Address
3-13-1, Yumachi, Chikushino City, Fukuoka
TEL
092-923-1551
Homepage URL
y-nakano@saiseikai-futsukaichi.org
Sponsor or person
Institute
Saiseikai Futsukaichi Hospital
Institute
Department
Personal name
Yuki Nakano
Funding Source
Organization
Saiseikai Futsukaichi 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
Saiseikai Futsukaichi Hospital Institutional review board
Address
3-13-1, Yumachi, Chikushino City, Fukuoka
Tel
092-923-1551
a-hayashi@saiseikai-futsukaichi.org
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 | 09 | Month | 30 | 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
| 2023 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 30 | Day |
Other
Other related information
Primary endpoints
Hypokalemia
Secondary endpoints
Rhabdomyolysis
Pseudohyperaldosteronism
Hypertension
Management information
Registered date
| 2023 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059606
