UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036403 |
|---|---|
| Receipt number | R000041470 |
| Scientific Title | Non-invasive marker to predict the remission of diabetic kidney disease for well-managed diabetic patient-2. |
| Date of disclosure of the study information | 2019/04/05 |
| Last modified on | 2022/10/05 14:27:16 |
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Basic information
Public title
Non-invasive marker to predict the remission of diabetic kidney disease for well-managed diabetic patient-2.
Acronym
DKDrem-2
Scientific Title
Non-invasive marker to predict the remission of diabetic kidney disease for well-managed diabetic patient-2.
Scientific Title:Acronym
DKDrem-2
Region
| Japan |
Condition
Condition
Diabetic Kidney Disease
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of the non-invasive marker to predict the effectiveness of control of multiple risk factors for improving diabetic kidney disease
Basic objectives2
Others
Basic objectives -Others
Establishment of the method of evaluating the effect of the treatment for improving diabetic kidney disease
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Deceleration of the rate of eGFR(estimated glomerular filtration rate) decline
Key secondary outcomes
the rate of eGFR(estimated glomerular filtration rate) decline
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
(1)type 2 diabetic patients
(2)eGFR(estimated glomerular filtration rate)<60ml/min/1.73m2 or urinary albumin creatinine ratio>30mg/g Cr
(3)patients followed-up for more than 3 months
Key exclusion criteria
(1)pregnancy
(2)malignant tumors
(3)patients having the history of cerebral infarction within 1 year prior to obtaining consent.
(4)severe orthostatic hypotension
(5)chronic urinary tract infection
(6)congestive heart failure
(7)neurogenic bladder
(8)nondiabetic kidney disease
(9)severe emaciation (BMI<18kg/m2)
(10)endstage renal disease
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Motonobu |
| Middle name | |
| Last name | Nihsimura |
Organization
National Hospital Organization Chibahigashi National Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
260-8712
Address
673, Nitonatyou, Tyuuou-ku, Chiba city, Chiba, 260-8712, Japan
TEL
043-261-5171
nishimura.motonobu.ky@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Motonobu |
| Middle name | |
| Last name | Nishimura |
Organization
National Hospital Organization Chibahigashi National Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
260-8712
Address
673, Nitonatyou, Tyuuou-ku, Chiba city, Chiba, 260-8712, Japan
TEL
043-261-5171
Homepage URL
nishimura.motonobu.ky@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
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
National Hospital Organization
Address
2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5075
700-kenkyu@mail.hosp.go.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
国立病院機構千葉東病院（千葉県）、国立病院機構函館病院（北海道）、国立病院機構渋川医療センター（群馬県）、国立病院機構三重中央医療センター（三重県）、国立病院機構京都医療センター（京都府）、国立病院機構岡山医療センター（岡山県）、国立病院機構大阪医療センタ（大阪府）、国立病院機構兵庫中央病院（兵庫県）、国立病院機構姫路医療センター（兵庫県）、国立病院機構呉医療センター（広島県）、国立病院機構東広島医療センター（広島県）、国立病院機構米子医療センター（鳥取県）、国立病院機構徳島病院（徳島県）、 国立病院機構鹿児島医療センター（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 05 | 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
233
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
| 2018 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
The method of registration of the patients (the patients who visited the participating institutions during April 2006 through October 2019, fulfilled the criteria)
Outcome assessment (serum creatinine level, urinary albumin excretion rate, urinary protein excretion rate, HbA1c, LDL-cholesterol, clinic blood pressure, home blood pressure, renal ultrasonography, urinary podocyte, serum thrombomodulin, serum erythropoietin, ect)
Management information
Registered date
| 2019 | Year | 04 | Month | 03 | Day |
Last modified on
| 2022 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041470
