UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049168 |
|---|---|
| Receipt number | R000056006 |
| Scientific Title | Analysis of additional granulocyte and monocyte adsorption therapy for incomplete remission induction in ulcerative colitis |
| Date of disclosure of the study information | 2022/10/09 |
| Last modified on | 2023/04/10 19:26:51 |
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Basic information
Public title
Analysis of additional granulocyte and monocyte adsorption therapy for incomplete remission induction in ulcerative colitis
Acronym
Additional treatment with GMA in UC
Scientific Title
Analysis of additional granulocyte and monocyte adsorption therapy for incomplete remission induction in ulcerative colitis
Scientific Title:Acronym
Additional treatment with GMA in UC
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the timing and efficacy of granulocyte/monocyte adsorption addition to induction remission therapy with corticosteroids, calcineurin inhibitors, and anti-cytokine therapy for active UC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The success rate of remission induction with granulocyte/monocyte adsorption combination.
Key secondary outcomes
Treatment success rates by timing of granulocyte/monocyte adsorption addition, comparison of days to induction of remission, incidence of incident events, and steroid-free remission rates at 52 weeks.
Base
Study type
Observational
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Ulcerative colitis patients who underwent outpatient or inpatient granulocyte/monocyte adsorption at our hospital between August 1, 2012 and May 31, 2021.
Key exclusion criteria
Patients who oral administration adherence is less than 80%.
Patients who did not complete granulocyte/monocyte adsorption because of vascular securing difficulty.
Patients who treated with granulocyte/monocyte adsorption monotherapy.
Target sample size
194
Research contact person
Name of lead principal investigator
| 1st name | Mimari |
| Middle name | |
| Last name | Kanazawa |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
3210293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL
+81-282-87-2147
mimari77@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Mimari |
| Middle name | |
| Last name | Kanazawa |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
3210293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL
+81-282-87-2147
Homepage URL
mimari77@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None.
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
Clinical Research Review Committee, Dokkyo Medical University Hospital
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
Tel
+81-282-86-1111
r-kenkyu@dokkyomed.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
| 2022 | Year | 10 | Month | 09 | 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
194
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
| 2021 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 10 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 01 | Day |
Other
Other related information
Patients with ulcerative colitis who received granulocyte/monocyte adsorption as outpatients or inpatients at our hospital between August 1, 2012 and May 31, 2021 were included. Patients whose adherence to oral medication was less than 80% of the prescribed dose, patients who could not complete granulocyte/monocyte adsorption due to vascular security problems, and patients who received induction remission therapy using granulocyte/monocyte adsorption alone were excluded.
Management information
Registered date
| 2022 | Year | 10 | Month | 09 | Day |
Last modified on
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056006
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
