UMIN-CTR Clinical Trial

Public title

Clinical and pathological predictors of estimated GFR decline in patients with type 2 diabetes and macroalbuminuric diabetic nephropathy

Acronym

eGFR decline in biopsy-proven diabetic nephropathy

Scientific Title

Clinical and pathological predictors of estimated GFR decline in patients with type 2 diabetes and macroalbuminuric diabetic nephropathy

Scientific Title:Acronym

eGFR decline in biopsy-proven diabetic nephropathy

Region

Japan

Condition

Diabetic nephropathy

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the relationships of the eGFR decline with clinical and pathological variables in patients with type 2 diabetes and macroalbuminuric biopsy-proven diabetic nephropathy

Basic objectives2

Others

Basic objectives -Others

To compare the utility as a predictor of rapid eGFR decliners between clinical and pathological variables.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Annual eGFR decline

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

Transplanted kidney
Coexistence of other renal diseases except for nephrosclerosis
Type I diabetes
normoalbuminuria or microalbuminuria
eGFR <15 mL/min/1.73 m2 at baseline
follow-up for less than 12 months except for commencement of dialysis within 12 months

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Yoshifumi Ubara

Organization

Toranomon Hospital

Division name

Nephrology Center

Zip code

Address

2-2-2, Toranomon, Minato-ku, Tokyo, 105-0001, Japan

TEL

03-3588-1111

Email

ubara@toranomon.gr.jp

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

Institute

Nephrology Center, Toranomon Hospital

Institute

Department

Personal name

Organization

Okinaka Memorial Institute for Medical Research

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

虎の門病院(東京)、虎の門病院分院(神奈川県)

Date of disclosure of the study information

2014

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/25533683

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

03

Month

13

Day

Date of IRB

Anticipated trial start date

2014

Year

03

Month

14

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Serum creatinine was measured more than once a year and at final follow-up in each patient. The GFR was estimated by using the Japanese coefficient-modified Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
For each patient, a linear regression model of time versus eGFR was created, and the slope of the regression line was used to estimate the changes of eGFR over time. The eGFR slope was also expressed as an annual percentage (the slope divided by the baseline eGFR).
Multivariate linear regression analyses were employed to explore the association of annual eGFR decline with baseline clinical and histopathological covariates. In each model, the dependent variable was annual eGFR decline (% per year), while the age, sex, BMI, diabetic retinopathy, and clinical and histopatological variables at the time of renal biopsy were included as covariates.

Registered date

2014

Year

03

Month

13

Day

Last modified on

2015

Year

06

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015647