UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050812 |
|---|---|
| Receipt number | R000057905 |
| Scientific Title | Relationship between the effect of roxadustat and comorbidity of diabetes in non-dialysis patients with chronic kidney disease |
| Date of disclosure of the study information | 2023/04/11 |
| Last modified on | 2024/01/09 14:08:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Relationship between the effect of roxadustat and comorbidity of diabetes in non-dialysis patients with chronic kidney disease
Acronym
Relationship between the effect of roxadustat and comorbidity of diabetes in non-dialysis patients with chronic kidney disease
Scientific Title
Relationship between the effect of roxadustat and comorbidity of diabetes in non-dialysis patients with chronic kidney disease
Scientific Title:Acronym
Relationship between the effect of roxadustat and comorbidity of diabetes in non-dialysis patients with chronic kidney disease
Region
| Japan |
Condition
Condition
renal anemia, chronic kidney disease, diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Retrospective study to determine the factors influencing the efficacy of roxadustat in non-dialysis CKD patients, with a particular focus on comorbid diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes in the dose over 6 months after initiation of roxadustat
Key secondary outcomes
Changes in hemoglobin levels and achievement rates of target hemoglobin levels over 6 months after initiation of roxadustat
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non-dialysis patients with chronic kidney disease and renal anemia
Key exclusion criteria
Patients who were transferred to another hospital within a month after the initiation of roxadustat
Patients whose hemoglobin level of 11 g/dL or higher at the initiation of roxadustat
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
TEL
03-3673-1221
ito@edogawa.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
TEL
03-3673-1221
Homepage URL
ito@edogawa.or.jp
Sponsor or person
Institute
Edogawa Hospital
Institute
Department
Personal name
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
Edogawa Hospital
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
Tel
03-3673-1221
ito@edogawa.or.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 | 04 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.cureus.com/articles/156342-relationship-between-the-effect-of-roxadustat-and-comorbid-di
Publication of results
Published
Result
URL related to results and publications
https://www.cureus.com/articles/156342-relationship-between-the-effect-of-roxadustat-and-comorbid-di
Number of participants that the trial has enrolled
44
Results
The comorbidities of DM and BW at baseline were significantly associated with each dose of ROX at 6 M and the change in each dose of ROX. There was no difference in the amount of increase in the Hb level and the rate of Hb target achievement between patients with and without DM. Each dose of ROX gradually decreased in patients without DM, whereas it increased in those with DM. Each dose of ROX was significantly higher in patients with DM than in those without DM at 3 and 6 M after the initiation of ROX.
Results date posted
| 2024 | Year | 01 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 05 | Month | 26 | Day |
Baseline Characteristics
44 patients with chronic kidney disease treated using roxadustat
Participant flow
44 patients with chronic kidney disease treated using roxadustat
Adverse events
Adverse events were found in 9 patients
Outcome measures
Hb, dose of roxadustat
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observation study
Management information
Registered date
| 2023 | Year | 04 | Month | 11 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057905
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
