UMIN-CTR Clinical Trial

Public title

Clinical significance of skin autofluorescence in chronic kidney disease and diabetes

Acronym

Skin autofluorescence in chronic kidney disease and diabetes

Scientific Title

Clinical significance of skin autofluorescence in chronic kidney disease and diabetes

Scientific Title:Acronym

Skin autofluorescence in chronic kidney disease and diabetes

Region

Japan

Condition

Chronic kidney disease; Diabetes

Classification by specialty

Endocrinology and Metabolism

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess whether skin autofluorescence predicts renal prognosis and mortality in patients with chronic kidney disease and/or diabetes.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Doubling of serum creatinine and/or need for dialysis

Key secondary outcomes

Total mortality; cardiavascular death; non-fatal cardiavascular event

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 chronic kidney disease and/or diabetes

Key exclusion criteria

Active malignancy; Pregnancy; Organ transplantation

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	Tsuyoshi Watanabe

Organization

Fukushima Medical University

Division name

Department of Nephrology, Hypertension, Diabetology, Endcrinology, and Metabolism

Zip code

Address

1, Hikarigaoka, Fukushima City

TEL

024-547-1111

Email

im3@fmu.ac.jp

Name of contact person

1st name
Middle name
Last name	Kenichi Tanaka

Organization

Fukushima Medical University

Division name

Department of Nephrology, Hypertension, Diabetology, Endcrinology, and Metabolism

Zip code

Address

1, Hikarigaoka, Fukushima City

TEL

024-547-1111

Homepage URL

Email

im3@fmu.ac.jp

Institute

Fukushima Medical University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

Date of disclosure of the study information

2013

Year

11

Month

13

Day

URL releasing protocol

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0083799

Publication of results

Partially published

URL related to results and publications

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0083799

Number of participants that the trial has enrolled

449

Results

Significant relationship was observed between skin autofluorescence and CKD progression in patients with CKD (PLoS One. 2013 Dec 12;8(12):e83799).

Results date posted

2020

Year

05

Month

19

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

We initially examined the baseline characteristics of 449 CKD patients. Thirty three patients were lost to follow-up, and a total of 416 (93%) patients from the baseline cohort could be assessed during the follow-up. Further analyses were conducted in 416 patients who completed follow-up. A continuous and significant increase in skin autofluorescence was observed across CKD stages. Blood pressure, proteinuria and uric acid increased, and serum albumin, hemoglobin and high-density lipoprotein-cholesterol decreased as CKD stage advanced. Angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB) were administered to 290 patients (70%).

Participant flow

The patients were prospectively followed-up until October 2012 or until the study end point was reached. Patients received regular follow-up care in the outpatient ward. The primary kidney end point was defined as a combination of doubling of baseline serum creatinine and end-stage kidney disease requiring kidney replacement therapy. The secondary end point consisted of a composite of the primary kidney end point and all-cause death. Thirty three patients were lost to follow-up. A total of 416 (93%) patients from the baseline cohort could be assessed during the follow-up.

Adverse events

None(observational study)

Outcome measures

The primary kidney end point was defined as a combination of doubling of baseline serum creatinine and end-stage kidney disease requiring kidney replacement therapy. The secondary end point consisted of a composite of the primary kidney end point and all-cause death.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2006

Year

03

Month

30

Day

Date of IRB

2006

Year

04

Month

15

Day

Anticipated trial start date

2006

Year

04

Month

01

Day

Last follow-up date

2015

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Annual observation is performed for 5 years from registration.

Registered date

2013

Year

11

Month

13

Day

Last modified on

2020

Year

05

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014365