UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The analysis of renal complication associated with Rheumatoid Arthritis
Title of the study (Brief title)	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	Yoshifumi Ubara
Organization	Toranomon hospital
Division name	Department of Nephrology
Address	1-3-1 Kajigaya, Takatsu, Kawasaki, Kanagawa, JAPAN
TEL	044-877-5111
Email	ubara@toranomon.gr.jp

Public contact
Name of contact person	Toshiharu Ueno
Organization	Toranomon hospital
Division name	Department of Nephrology
Address	1-3-1 Kajigaya, Takatsu, Kawasaki, Kanagawa, JAPAN
TEL	81-44-877-5111
Homepage URL
Email	ueno.toshiharu1978@gmail.com

Sponsor
Institute	Toranomon hospital
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	1986 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037097