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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024090
Receipt No. R000027734
Scientific Title An observational study of outcomes in adult lupus nephritis patients : a nationwide retrospective cohort study.
Date of disclosure of the study information 2016/09/16
Last modified on 2018/03/26

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Basic information
Public title An observational study of outcomes in adult lupus nephritis patients : a nationwide retrospective cohort study.
Acronym Study of outcomes of lupus nephritis
Scientific Title An observational study of outcomes in adult lupus nephritis patients : a nationwide retrospective cohort study.
Scientific Title:Acronym Study of outcomes of lupus nephritis
Region
Japan

Condition
Condition Lupus nephritis
Classification by specialty
Medicine in general Nephrology Clinical immunology
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is a retrospective cohort study in adult patients who were registered in Japan Renal Biopsy Registry between Jan 2007 and Dec 2012, with a histological diagnosis of lupus nephritis. The primary goal of this study is to clarify renal outcomes of lupus nephritis in total and in each histological classes. The secondary goal is to examine patterns of initial treatment, rate of complete remission, mortality and complications in each histology. In addition, risk factors for deterioration of renal function and patient death are investigated.
Basic objectives2 Others
Basic objectives -Others Not applicable
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Doubling of serum creatinine or end-stage renal disease requiring renal replacement therapy
Key secondary outcomes 1) A 50% increase in serum creatinine
2) End-stage renal disease requiring renal replacement therapy
3) Good renal outcome (serum creatinine =< 1.0mg/dl, at the final observation)
4) Death
5) Cardiovascular diseases
6) Malignant tumor
7) Complete remission at 6 months after initiation of treatment (or renal biopsy)
8) Complete remission at 12 months after initiation of treatment (or renal biopsy)
9) Repeat biopsy

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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1)Already registered in J-RBR before Sep 17, 2013
2)Received renal biopsy between Jan 1, 2007 and Dec 31, 2012
3)18 years old or older at the time of biopsy
4)Fulfilled 4 or more of the ACR criteria for the classification of SLE
5)Registered with a histological diagnosis of lupus nephritis
6)Japanese
Key exclusion criteria 1)No medical records at 6 months or later after renal biopsy. Patients who reached a 50% increase in serum creatinine, end stage renal failure requiring renal replacement therapy or died were not excluded.
2)Insufficient biopsy sample for the diagnosis of ISN/RPS classification
3)Patients who are judged to be inappropriate for the study by the investigator.
4)Patients who decline participation of the study.

Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiju Hiromura
Organization Gunma University Hospital
Division name Division of Nephrology and Rheumatology
Zip code
Address 3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL 027-220-8166
Email hiromura@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidekazu Ikeuchi
Organization Gunma University Hospital
Division name Division of Nephrology and Rheumatology
Zip code
Address 3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL 027-220-8166
Homepage URL
Email hikeuchi@gunma-u.ac.jp

Sponsor
Institute Japanese Society of Nephrology
Institute
Department

Funding Source
Organization Japanese Society of Nephrology
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 16 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 No longer recruiting
Date of protocol fixation
2016 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information Not applicable

Management information
Registered date
2016 Year 09 Month 16 Day
Last modified on
2018 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027734

Research Plan
Registered date File name
2017/09/27 【資料1】ループス腎炎 研究計画書.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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