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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020882
Receipt No. 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

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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
Email 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
Email ihata-atsushi@yokohamamc.jp

Sponsor
Institute National Hospital Organization Yokohama Medical Center, Department of Rheumatology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024064

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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