UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Paratubular basement membrane insudative lesions predict renal prognosis in patients with type 2 diabetes and biopsy-proven diabetic nephropathy
Title of the study (Brief title)	Paratubular basement membrane insudative lesions
Region	Japan

Condition
Condition	Diabetic nephropathy
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the association between paratubular basement membrane insudative lesions and renal prognosis in patients with biopsy-proven diabetic nephropathy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	40% eGFR decline from baseline
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with type 2 diabetes who underwent renal biopsy at Toranomon hospital (Toranomon Main Hospitan and Toranomon Hospital Kajigaya) from January 1998 to June 2011 and were confirmed to have DN alone.
Key exclusion criteria	Exclusion criterion was eGFR < 10ml/min/1.73m2 at the time of renal biopsy.
Target sample size	120

Research contact person
Name of lead principal investigator	Yoshifumi Ubara
Organization	Toranomon Hospital Kajigaya
Division name	Nephrology Center
Address	1-3-1, Kajigaya, Takatu-ku, Kawasaki-shi, Kanagawa-ken, 213-0015, Japan
TEL	044-877-5111
Email	ubara@toranomon.gr.jp

Public contact
Name of contact person	Koki Mise
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Address	2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama-ken, 700-8558, Japan
TEL	086-235-7235
Homepage URL
Email	kokims-frz@umin.ac.jp

Sponsor
Institute	Toranomon Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	The Japanese Agency for Medical Research and Development. Okinaka Memorial Institute for Medical Research. Japan Association for Diabetes Education and Care. The Kidney Foundation, Japan.
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	虎の門病院分院(神奈川県)、虎の門病院(東京)

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 02 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	Among most patients who were eligible for this study, various severity of insudation between tubular epithelial cells and the tubular basement membrane (TBM) was observed in cortex and medulla. We named the insudative lesion as paratubular basement membrane isudative lesions (PTBMIL). PTBMIL in cortex and medulla were classified into four grades according to the severiry. Finally, patients were classified into three groups according to the total of cortical and medullary PTBMIL grades. The Cox proportional hazard model was used to calculate the hazard ratio (HR) and 95% confidence interval (CI) for the death-censored endpoint. We investigated the hazard ratio of PTBMIL groups for the outcome of interest in univariate and multivariate Cox proportional models.

Management information
Registered date	2016 Year 05 Month 30 Day
Last modified on	2016 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025972