UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043514 |
|---|---|
| Receipt number | R000049684 |
| Scientific Title | Effectiveness and safety of cyclophosphamide for older microscopic polyangiitis patients on induction therapy |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2024/03/09 12:53:06 |
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Basic information
Public title
Effectiveness and safety of cyclophosphamide for older microscopic polyangiitis patients on induction therapy
Acronym
Effectiveness and safety of cyclophosphamide for older microscopic polyangiitis patients on induction therapy
Scientific Title
Effectiveness and safety of cyclophosphamide for older microscopic polyangiitis patients on induction therapy
Scientific Title:Acronym
Effectiveness and safety of cyclophosphamide for older microscopic polyangiitis patients on induction therapy
Region
| Japan |
Condition
Condition
Microscopic polyangitis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
ANCA-associated vasculitis (AAV) is a serious disease that can lead to multi-organ failure, including kidney, due to systemic vasculitis.Treatment with glucocorticoid and immunosuppressive drugs are required to induce and to maintain disease remission state. Microscopic polyangiitis (MPA), which accounts for the majority of AAV in Japan, is known to be more likely to occur in the elderly. However, cyclophosphamide is often prescribed as reduced dose or unuse drug for the elderly, concerning about the risk of infection. There is no previous evidence on the usefulness and safety of cyclophosphamide in elderly MPA patients. In this study, we will examine the survival prognosis, renal prognosis, and incidence of serious adverse events in elderly MPA patients who received and did not receive cyclophosphamide based on existing data to verify the effectiveness and safety of cyclophosphamide for the elderly patients with MPA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All cause mortality and renal survival
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
| 70 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
MPA patients aged 70 years or older who were diagnosed and treated at the Department of Nephrology, Kitano Hospital from 2001 to 2016
Key exclusion criteria
Patients who did not wish to actively treat vasculitis with immunosuppressive drugs
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | Tsukamoto |
| Last name | Tsukamoto |
Organization
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Division name
Department of Nephrology & Dialysis
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka
TEL
0663121221
tatsuo.tsukamoto@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | Tsukamoto |
| Last name | Tsukamoto |
Organization
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Division name
Department of Nephrology & Dialysis
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka
TEL
06-63121-1221
Homepage URL
t-tsukamoto@kitano-hp.or.jp
Sponsor or person
Institute
Department of Nephrology & Dialysis
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Department of Nephrology & Dialysis
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Address
2-4-20 Ohgimachi, Kita-ku, Osaka
Tel
06-6312-1221
rinshou@kitano-hp.or.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
| 2021 | Year | 04 | Month | 01 | 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
10
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
in submission
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
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2021 | Year | 03 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049684
| Research Plan | |
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| 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 |
