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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012285
Receipt No. R000014365
Scientific Title Clinical significance of skin autofluorescence in chronic kidney disease and diabetes
Date of disclosure of the study information 2013/11/13
Last modified on 2020/05/19

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Basic information
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
Condition Chronic kidney disease; Diabetes
Classification by specialty
Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes Doubling of serum creatinine and/or need for dialysis
Key secondary outcomes Total mortality; cardiavascular death; non-fatal cardiavascular event

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 chronic kidney disease and/or diabetes
Key exclusion criteria Active malignancy; Pregnancy; Organ transplantation
Target sample size 500

Research contact person
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

Public contact
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

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 13 Day

Related information
URL releasing protocol https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0083799
Publication of results Partially published

Result
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

Progress
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
Other related information Annual observation is performed for 5 years from registration.

Management information
Registered date
2013 Year 11 Month 13 Day
Last modified on
2020 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014365

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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