UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016662
Receipt number R000019339
Scientific Title Prognostic value of tubulointerstitial lesions, urinary N-acetyl-B-D-glucosaminidase, and urinary B2-microgrobulin in patients with type 2 diabetes and biopsy-proven diabetic nephropathy.
Date of disclosure of the study information 2015/02/27
Last modified on 2015/08/31 09:09:25

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Basic information

Public title

Prognostic value of tubulointerstitial lesions, urinary N-acetyl-B-D-glucosaminidase, and urinary B2-microgrobulin in patients with type 2 diabetes and biopsy-proven diabetic nephropathy.

Acronym

Tubulointerstitial lesions and urinary biomarkers

Scientific Title

Prognostic value of tubulointerstitial lesions, urinary N-acetyl-B-D-glucosaminidase, and urinary B2-microgrobulin in patients with type 2 diabetes and biopsy-proven diabetic nephropathy.

Scientific Title:Acronym

Tubulointerstitial lesions and urinary biomarkers

Region

Japan


Condition

Condition

Diabetic nephropathy

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the relationships of the extent of interstitial fibrosis and tubular atrophy with urinary NAG and urinary B2-MG, and to compared the value of these markers for predicting the renal prognosis in patients with type 2 diabetes and biopsy-proven DN.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

A decline of eGFR by at least 50% from baseline or commencement of dialysis due to end-stage renal disease

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with type2 diabetes who underwent renal biopsy at our hospital from March 1985 to June 2011 and were confirmed to have diabetic nephropathy according to Tervaert's classification(J Am Soc Nephrol. 2010;21(4):556-63)

Key exclusion criteria

Patients in whom urinary NAG and B2-MG were not examined at the time of renal biopsy
Patients whose baseline eGFR was <10 mL/min/1.73m2

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshifumi Ubara

Organization

Toranomon Hospital Kajigaya

Division name

Nephrology Center

Zip code


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

1st name
Middle name
Last name Koki Mise

Organization

Toranomon Hospital Kajigaya

Division name

Nephrology Center

Zip code


Address

1-3-1, Kajigaya, Takatu-ku, Kawasaki-shi, Kanagawa-ken, 213-0015, Japan

TEL

044-877-5111

Homepage URL


Email

kokims-frz@umin.ac.jp


Sponsor or person

Institute

Toranomon Hospital

Institute

Department

Personal name



Funding Source

Organization

Okinaka Memorial Institute for Medical Research

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

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

2015 Year 02 Month 27 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

Completed

Date of protocol fixation

2015 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Cox proportional hazards regression analysis was used to calculate the hazard ratio and 95% confidence interval for death-censored endpoint, with each regression analysis examining two levels of multivariate adjustment.


Management information

Registered date

2015 Year 02 Month 27 Day

Last modified on

2015 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019339


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name