UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061224 |
|---|---|
| Receipt number | R000070058 |
| Scientific Title | Comparison of outpatient visit frequency, visit duration, and drug-related costs between HIF-PH inhibitors and erythropoiesis-stimulating agents for renal anemia in patients with chronic kidney disease: a single-center retrospective observational study |
| Date of disclosure of the study information | 2026/04/11 |
| Last modified on | 2026/04/10 14:11:53 |
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Basic information
Public title
Comparison of outpatient visit patterns for renal anemia in patients with chronic kidney disease
Acronym
CKD Anemia Visit Study
Scientific Title
Comparison of outpatient visit frequency, visit duration, and drug-related costs between HIF-PH inhibitors and erythropoiesis-stimulating agents for renal anemia in patients with chronic kidney disease: a single-center retrospective observational study
Scientific Title:Acronym
CKD Anemia Visit Study
Region
| Japan |
Condition
Condition
renal anemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
HIF-PH inhibitors are administered orally, whereas erythropoiesis-stimulating agents (ESAs) require subcutaneous injection. These differences may affect outpatient clinical workflow, as well as outpatient visit frequency, outpatient visit duration, and drug-related costs. This retrospective observational study aims to compare outpatient visit frequency, outpatient visit duration, and drug-related costs between patients receiving HIF-PH inhibitors and those receiving ESAs among patients with non-dialysis chronic kidney disease (CKD).
Basic objectives2
Others
Basic objectives -Others
The aim of this retrospective observational study is to describe and compare outpatient treatment practices, and not to evaluate the efficacy, safety, or superiority of the medications.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outpatient visit frequency (number of visits per year), outpatient visit duration, and drug-related costs based on drug prices.
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
| 15 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with non-dialysis chronic kidney disease (CKD) who attended the outpatient department of the Department of Nephrology and Endocrinology at the University of Tokyo Hospital between January 1, 2022 and December 31, 2025, and who received or were prescribed erythropoiesis-stimulating agents (ESAs) or HIF-PH inhibitors during the observation period.
Key exclusion criteria
Patients who were considered inappropriate for inclusion in the study by the investigators, or who declined the use of their information for research purposes.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Sayako |
| Middle name | |
| Last name | Maruno |
Organization
The University of Tokyo Hospital
Division name
Department of Nephrology and Endocrinology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL
03-3815-5411
smaruno-tky@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Sayako |
| Middle name | |
| Last name | Maruno |
Organization
The University of Tokyo Hospital
Division name
Department of Nephrology and Endocrinology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL
03-3815-5411
Homepage URL
smaruno-tky@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Sayako Maruno
Funding Source
Organization
Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2026 | Year | 04 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center retrospective observational study using electronic medical records (EMRs). Patients with non-dialysis chronic kidney disease (CKD) who received or were prescribed erythropoiesis-stimulating agents (ESAs) or HIF-PH inhibitors will be included. The primary outcomes are outpatient visit frequency, outpatient visit duration, and drug-related costs based on drug prices, which will be compared between groups. Secondary analyses will include visit intervals stratified by renal function, visit intervals and hemoglobin values outside the target range during the initiation phase, and the proportion of patients with long visit intervals. Analyses will be primarily based on descriptive comparisons.
Management information
Registered date
| 2026 | Year | 04 | Month | 10 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070058
