UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020906 |
|---|---|
| Receipt number | R000019632 |
| Scientific Title | Clinical features of MTX-related pancytopenia |
| Date of disclosure of the study information | 2016/02/07 |
| Last modified on | 2016/05/01 09:13:34 |
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Basic information
Public title
Clinical features of MTX-related pancytopenia
Acronym
Clinical features of MTX-related pancytopenia
Scientific Title
Clinical features of MTX-related pancytopenia
Scientific Title:Acronym
Clinical features of MTX-related pancytopenia
Region
| Japan |
Condition
Condition
Rheumatoid arthhritis
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Nephrology |
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Severe myelosuppression is a serious concern in the management of rheumatic disease patients receiving methotrexate (MTX) therapy. This study was intended to explore factors associated with the development of MTX-related myelosuppression and its disease severity.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
eGFR
eGFR corrected by body surface area
Duration from MTX administration
MTX dose at onset of pancytopenia
Presence of acute renal insuffciency
Preceded dehyration
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cytopenia patients induced by low dose MTX therapy.
And age and sex matched control.
Key exclusion criteria
None
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Mori |
Organization
NHO Kumamoto Saishunsou National Hospital
Division name
Rheumatology
Zip code
Address
2659 Suya Kohshi, Kumamoto, Japan
TEL
81-96-242-1000
moris@saisyunsou1.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kokubo Katsunori |
Organization
NHO Kumamoto Saishunsou National Hospital
Division name
Rheumatology
Zip code
Address
2659 Suya, Kohshi, Kumamoto Japan
TEL
81-96-242-1000
Homepage URL
8211syo1@hosp.go.jp
Sponsor or person
Institute
NHO Kumamoto Saishunsou National Hospital
Institute
Department
Personal name
Funding Source
Organization
NHO Kumamoto Saishunsou National Hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
熊本医療センター血液内科（熊本県）、熊本市民病院（熊本県）、長崎医療センター（長崎県）、佐世保中央病院（長崎県）、吉玉リウマチ科内科（鹿児島県）、織部リウマチ科内科（大分県）、熊本再春荘病院（熊本県）、市民の森病院（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Non-use of folic acid supplements, concurrent medications, and low renal functions were signiicantly associated with the development of myelosuppression. In addition, significantly lower MTX dosages, higher blood cell counts, and lower hemoglobin levels were seen in the myelosuppression group. No patients exibited leukocytopenia, neutropenia, or thrombocytopenia in routine blood monitoring taken within the past month. One-fourth developed myelosuppression within the first two months. Myelosuppression was severe in approximately 40% of patients. Hypoalbuminemia and non-use of folic acid supplements were significantly associated with the severity of pancytopenia. Besides these two factors, early onset and the use of lowere doses of MTX were significantly associated with the severity of neutropenia.
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
Main results already published
Date of protocol fixation
| 2014 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 28 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 29 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 29 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 29 | Day |
Other
Other related information
eGFR
eGFR corrected b body surface area
Degree of Pancytopenia
Acute kidney insufficiency
Serum albumin
Prognosis
Management information
Registered date
| 2016 | Year | 02 | Month | 06 | Day |
Last modified on
| 2016 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019632
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2016/05/01 | Mori S MTX myelosupp.pdf |
