UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020882 |
|---|---|
| Receipt number | R000024064 |
| Scientific Title | The efficacy of ovarian preservation therapy in patients with systemic lupus erythematosus treated with cyclophosphamide pulse therapy - multi center observational study. |
| Date of disclosure of the study information | 2016/02/07 |
| Last modified on | 2017/02/08 11:32:33 |
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Basic information
Public title
The efficacy of ovarian preservation therapy in patients with systemic lupus erythematosus treated with cyclophosphamide pulse therapy - multi center observational study.
Acronym
The efficacy of ovarian preservation therapy in patients with systemic lupus erythematosus treated with cyclophosphamide pulse therapy
Scientific Title
The efficacy of ovarian preservation therapy in patients with systemic lupus erythematosus treated with cyclophosphamide pulse therapy - multi center observational study.
Scientific Title:Acronym
The efficacy of ovarian preservation therapy in patients with systemic lupus erythematosus treated with cyclophosphamide pulse therapy
Region
| Japan |
Condition
Condition
systemic lupus erythematosus
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of monthly GnRH against premenopausal ovarian impairment induced by intravenous cyclophosphamide therapy in patients with systemic lupus erythematosus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The incidence of premenopausal ovarian insufficiency
Key secondary outcomes
parity
pregnancy
exacerbation of systemic lupus erythematosus
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
| Not applicable |
Gender
Female
Key inclusion criteria
Patients who had a diagnosis of SLE (fulfilled 4/11 American College of Rheumatology revised criteria)
Patients who were eighteen years or older female.
Patients who received more than 6 courses of IVCY
Patients who provided a written informed concent.
Key exclusion criteria
Patients whom investigators judged inappropriate for this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Ihata |
Organization
National Hospital Organization Yokohama Medical Center
Division name
Department of Rheumatology
Zip code
Address
3-60-2, harajuku, Totsuka-ku, Yokohama city
TEL
045-851-2621
ihata-atsushi@yokohamamc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Ihata |
Organization
National Hospital Organization Yokohama Medical Center
Division name
Department of Rheumatology
Zip code
Address
3-60-2, harajuku, Totsuka-ku, Yokohama city
TEL
045-851-2621
Homepage URL
ihata-atsushi@yokohamamc.jp
Sponsor or person
Institute
National Hospital Organization Yokohama Medical Center, Department of Rheumatology
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
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
横浜南共済病院（神奈川県）、横浜市立大学附属病院（神奈川県）、横浜市立大学附属市民医療センター（神奈川県）、国立病院機構横浜医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Case control study.
All patients with SLE who were treated with a monthly regimen of cyclophosphamide pulses for lupus nephritis at these institutes, between February 2016 and August 2016.
Management information
Registered date
| 2016 | Year | 02 | Month | 04 | Day |
Last modified on
| 2017 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024064
