UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032529
Receipt number R000037097
Scientific Title The analysis of renal complication associated with Rheumatoid Arthritis
Date of disclosure of the study information 2018/05/18
Last modified on 2018/05/09 16:35:24

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Basic information

Public title

The analysis of renal complication associated with Rheumatoid Arthritis

Acronym

The analysis of renal complication associated with Rheumatoid Arthritis

Scientific Title

The analysis of renal complication associated with Rheumatoid Arthritis

Scientific Title:Acronym

The analysis of renal complication associated with Rheumatoid Arthritis

Region

Japan


Condition

Condition

Rheumatoid Arhtritis

Classification by specialty

Nephrology Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the frequency and characteristics of renal complication associated with Rheumatoid Arthritis

Basic objectives2

Others

Basic objectives -Others

age, sex, duration of rheumatoid arthritis, Serum albumin, creatinine (Cr), estimated Glomerular Filtration Rate, renal histology

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The comparison of clinical profiles categorized by biopsy-proven renal Histology

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

20 years-old <=

Age-upper limit

99 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients diagnosed as clinical symptoms or laboratory-confirmed diagnosis rheumatoid arthritis.

Key exclusion criteria

The patients with other rheumatologic or autoimmune disease.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshifumi Ubara

Organization

Toranomon hospital

Division name

Department of Nephrology

Zip code


Address

1-3-1 Kajigaya, Takatsu, Kawasaki, Kanagawa, JAPAN

TEL

044-877-5111

Email

ubara@toranomon.gr.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiharu Ueno

Organization

Toranomon hospital

Division name

Department of Nephrology

Zip code


Address

1-3-1 Kajigaya, Takatsu, Kawasaki, Kanagawa, JAPAN

TEL

81-44-877-5111

Homepage URL


Email

ueno.toshiharu1978@gmail.com


Sponsor or person

Institute

Toranomon hospital

Institute

Department

Personal name



Funding Source

Organization

Toranomon hospital

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



Other administrative information

Date of disclosure of the study information

2018 Year 05 Month 18 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

Open public recruiting

Date of protocol fixation

1986 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

1986 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Clinical profile of 125 Rheumatoid Arthritis patients with renal dysfunction or urinaly abnormalities are compared by the biopsy-proven renal histology.


Management information

Registered date

2018 Year 05 Month 09 Day

Last modified on

2018 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037097


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name