UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023599
Receipt number R000027139
Scientific Title Prognosis, complications, and treatments of diabetic nephropathy: Prospective observational study
Date of disclosure of the study information 2016/09/01
Last modified on 2024/02/17 09:40:41

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Prognosis, complications, and treatments of diabetic nephropathy: Prospective observational study

Acronym

Prognosis, complications, and treatments of diabetic nephropathy: Prospective observational study

Scientific Title

Prognosis, complications, and treatments of diabetic nephropathy: Prospective observational study

Scientific Title:Acronym

Prognosis, complications, and treatments of diabetic nephropathy: Prospective observational study

Region

Japan


Condition

Condition

Diabetic nephropathy

Classification by specialty

Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To revise diagnostic criteria, stage classification, and treatment guidelines of diabetic nephropathy based on laboratory results and therapeutic regimen

Basic objectives2

Others

Basic objectives -Others

we make long-term, trailable prospective cohort to establish the situation of diabetic nephropathy

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Evaluation of serial renal dysfunction by proteinuria, albuminuria, and GFR
Cardiovascular event
2. The number of death according to stage classification
3. Cardiovascular event and onset of diabetic complications other than nephropathy

Key secondary outcomes

1. Risk factor analysis for the progression of renal dysfuction
2. therapeutic goalachievement


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Type 2 diabetes

Key exclusion criteria

1. Type 1 diabetes
2. Secondary diabetes
3. Concomitant renal disease other than diabetic nephropathy

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Gohda
Middle name
Last name Tomohito

Organization

Juntendo University Faculty of medicine

Division name

Division of Nephrology

Zip code

113-8421

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

goda@juntendo.ac.jp


Public contact

Name of contact person

1st name Gohda
Middle name
Last name Tomohito Gohda

Organization

Juntendo University Faculty of medicine

Division name

Division of Nephrology

Zip code

113-8421

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL


Email

goda@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

None

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

Juntendo University Faculty of medicine

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

Tel

03-3813-3111

Email

goda@juntendo.ac.jp


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 01 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

22

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 07 Month 29 Day

Date of IRB

2016 Year 07 Month 29 Day

Anticipated trial start date

2016 Year 07 Month 29 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

1. Evaluation of serial renal dysfunction by proteinuria, albuminuria, and GFR
Cardiovascular event
2. The number of death according to stage classification
3. Cardiovascular event and onset of diabetic complications other than nephropathy


Management information

Registered date

2016 Year 08 Month 12 Day

Last modified on

2024 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027139


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name