UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051443 |
|---|---|
| Receipt number | R000056488 |
| Scientific Title | Exploration of Clinical Indicators Available for Evaluation of Clinical Trials for Chronic Kidney Disease. |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2024/01/13 14:00:07 |
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Basic information
Public title
Exploration of Clinical Indicators Available for Evaluation of Clinical Trials for Chronic Kidney Disease - Evaluation Study for MRI Utilization -.
Acronym
Exploration of Clinical Indicators Available for Evaluation of Clinical Trials for Chronic Kidney Disease.
Scientific Title
Exploration of Clinical Indicators Available for Evaluation of Clinical Trials for Chronic Kidney Disease.
Scientific Title:Acronym
Exploration of Clinical Indicators Available for Evaluation of Clinical Trials for Chronic Kidney Disease.
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of clinical indicators that can be used to evaluate the pathophysiology of patients with chronic kidney disease.
Basic objectives2
Others
Basic objectives -Others
1) Evaluation of renal morphology and physiological parameters by magnetic resonance imaging
2) Evaluation of target molecule concentrations in blood and urine
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Results of blood and urine biomarkers and magnetic resonance imaging.
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 chronic kidney disease who are attending the Department of Nephrology at Saitama Medical University Hospital approximately every 1-2 months and who have indicated their willingness to consent to the study after receiving a written explanation.
Key exclusion criteria
(1) Patients deemed inappropriate by the principal investigator
(e.g., after introduction of renal replacement therapy, children (under 18 years old), acute kidney injury, unilateral renal disease (e.g., renal vascular hypertension), renal tumor, severe edematous disease (e.g., nephrotic syndrome), cystic disease, postrenal kidney disease)
(2) Patients who have changed the content of the given medication in the initial entry
(At the time of the change in the content of the medication because the purpose is to confirm the baseline [MRI, biomarkers] of the case.)
(3) Those whose MRI images or laboratory test results are deemed inappropriate for evaluation
(When the renal parenchyma is poorly delineated on MRI due to artifacts from body movement, atrophy, cysts, scarring, etc., or when the specimen acquisition and processing process is inappropriate and is inferred not to reflect the pathophysiology of the subject)
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Okada |
Organization
Saitama Medical University
Division name
Nephrology
Zip code
350-0495
Address
38 Morohongo Moroyama-machi Iruma-gun Saitama Japan
TEL
049-276-1611
hirookda@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Okada |
Organization
Saitama Medical University
Division name
Nephrology
Zip code
350-0495
Address
38 Morohongo Moroyama-machi Iruma-gun Saitama Japan
TEL
049-276-1611
Homepage URL
hirookda@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
CHUGAI PHARMACEUTICAL CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University
Address
38 Morohongo Moroyama-machi Iruma-gun Saitama Japan
Tel
049-276-1354
hirb@saitama-med.ac.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 01 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to develop clinical indices for chronic kidney disease (CKD) through analysis of renal MRI and blood and urine biomarkers that can be used to understand the pathophysiology of CKD patients and to evaluate new drugs. This is an exploratory (noninterventional) observational clinical study.
Management information
Registered date
| 2023 | Year | 06 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056488
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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