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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012847
Receipt No. R000015009
Scientific Title The impact of renal histopathological findings on anemia in patients with biopsy-proven diabetic nephropathy
Date of disclosure of the study information 2014/01/30
Last modified on 2015/06/10

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Basic information
Public title The impact of renal histopathological findings on anemia in patients with biopsy-proven diabetic nephropathy
Acronym Hb decline in diabetic nephropathy
Scientific Title The impact of renal histopathological findings on anemia in patients with biopsy-proven diabetic nephropathy
Scientific Title:Acronym Hb decline in diabetic nephropathy
Region
Japan

Condition
Condition Diabetic nephropathy
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate which renal histopathological findings are closely related to anemia in patients with diabetic nephropathy.
Basic objectives2 Others
Basic objectives -Others To clarify pathophysiology of anemia in patients with diabetic nephropathy
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes hemoglobin decline
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 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
Hemoglobin level<11g/dl at the time of renal biopsy
eGFR<15mL/min/1.73m2 at the time of renal biopsy
Less than 12 months of follow-up periods
treatment with erythropoietin stimulating agent at the time of renal biopsy
Target sample size 100

Research contact person
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

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
Institute Nephrology Center, Toranomon Hospital
Institute
Department

Funding Source
Organization Okinaka Memorial Institute for Medical Research
Organization
Division
Category of Funding Organization Non profit foundation
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(東京)、虎の門病院分院(神奈川県)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4407915/
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
2014 Year 01 Month 14 Day
Date of IRB
Anticipated trial start date
2014 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 Hemoglobin level was measured more than one time every year and at final follow-up in each individual.
For each patient, a linear regression model of time on hemoglobin was created, and the slope of the regression line was used to estimate the patient's changes in hemoglobin over time. Multivariable linear regression analyses were employed to explore the independent associations of annual hemoglobin decline with baseline clinical and histopathological covariates.

Management information
Registered date
2014 Year 01 Month 14 Day
Last modified on
2015 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015009

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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