UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063271 |
|---|---|
| Receipt number | R000072304 |
| Scientific Title | Baseline Mean Corpuscular Volume and Hemoglobin Response to HIF-Prolyl Hydroxylase Inhibitors in Maintenance Hemodialysis Patients: A Retrospective Observational Study |
| Date of disclosure of the study information | 2026/10/19 |
| Last modified on | 2026/10/19 13:06:13 |
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Basic information
Public title
Association between baseline mean corpuscular volume and hemoglobin response after HIF-prolyl hydroxylase inhibitor initiation in maintenance hemodialysis patients
Acronym
HIF-PHI MCV Study
Scientific Title
Baseline Mean Corpuscular Volume and Hemoglobin Response to HIF-Prolyl Hydroxylase Inhibitors in Maintenance Hemodialysis Patients: A Retrospective Observational Study
Scientific Title:Acronym
HIF-PHI MCV Study
Region
| Japan |
Condition
Condition
Renal anemia in maintenance hemodialysis patients
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether baseline mean corpuscular volume (MCV) is associated with the change in hemoglobin approximately 3 months after initiation of a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in maintenance hemodialysis patients.
Basic objectives2
Others
Basic objectives -Others
Exploration of clinical factors associated with treatment response
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between baseline MCV and change in hemoglobin from baseline to approximately 3 months after HIF-PHI initiation (delta Hb = 3-month hemoglobin - baseline hemoglobin).
The 3-month hemoglobin value is defined as the measurement closest to day 90 within days 60-120 after HIF-PHI initiation.
Key secondary outcomes
1. Multivariable analyses of the association between baseline MCV and 3-month hemoglobin change with additional adjustment for inflammatory, nutritional, demographic, and iron-related treatment factors.
2. Assessment of nonlinearity in the association between baseline MCV and hemoglobin change.
3. Exploratory comparison of the MCV-hemoglobin response association between HIF-PHI initiators and patients continuing darbepoetin therapy.
4. Exploratory sensitivity analyses additionally accounting for TSAT, ferritin, CRP, and albumin.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria:
1. Patients receiving maintenance hemodialysis at dialysis facilities within Tojinkai.
2. Patients who newly initiated a HIF-PH inhibitor between October 26, 2020 and May 28, 2026.
3. Patients with baseline hemoglobin and MCV measured from the same blood sample within 30 days before HIF-PHI initiation.
4. Patients with a hemoglobin measurement available between days 60 and 120 after HIF-PHI initiation.
5. Patients with evidence of persistent HIF-PHI treatment through approximately 3 months.
6. Patients who received darbepoetin alone during the 28 days before HIF-PHI initiation.
Key exclusion criteria
Patients meeting any of the following criteria will be excluded:
1. Baseline hemoglobin or MCV cannot be evaluated before HIF-PHI initiation.
2. No hemoglobin measurement is available between days 60 and 120 after HIF-PHI initiation.
3. Persistence of HIF-PHI treatment through approximately 3 months cannot be confirmed.
4. ESA treatment during the 28 days before HIF-PHI initiation was not darbepoetin alone, preventing uniform calculation of ERI for the primary analysis.
5. Patients who opt out of the use of their clinical information for this study.
Target sample size
97
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Suzuki |
Organization
Tojinkai Hospital
Division name
Department of Information Management
Zip code
612-8026
Address
83-1 Momoyamacho Iga, Fushimi-ku, Kyoto 612-8026, Japan
TEL
0756221991
suzuki@tojinkai.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Suzuki |
Organization
Tojinkai Hospital
Division name
Department of Information Management
Zip code
612-8026
Address
83-1 Momoyamacho Iga, Fushimi-ku, Kyoto 612-8026, Japan
TEL
0756221991
Homepage URL
suzuki@tojinkai.jp
Sponsor or person
Institute
Tojinkai 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
Ethics Review Committee, Tojinkai Hospital
Address
83-1 Momoyamacho Iga, Fushimi-ku, Kyoto 612-8026, Japan
Tel
0756221991
nagashima@tojinkai.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 | 10 | Month | 19 | 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
97
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
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study investigating the association between baseline mean corpuscular volume (MCV) and the change in hemoglobin (Hb) approximately 3 months after initiation of hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) in patients receiving maintenance hemodialysis.
Routinely collected clinical data from four dialysis facilities within a single healthcare organization are used, including baseline MCV, Hb, erythropoiesis-stimulating agent resistance index (ERI), inflammatory and nutritional markers, and iron-related parameters. The primary outcome is the change in Hb from baseline to approximately 3 months after HIF-PHI initiation.
The primary analysis includes patients who met the treatment-persistence criteria, had available baseline and follow-up Hb measurements, and had received darbepoetin alone during the 28 days preceding HIF-PHI initiation. Baseline MCV is analyzed as a continuous variable using multivariable linear regression. Exploratory analyses include an active-comparator analysis with patients continuing darbepoetin therapy and sensitivity analyses incorporating iron-related parameters.
This is a non-interventional study using existing clinical records, with no additional examinations or treatment interventions. The study was approved by an ethics committee (approval no. 2026-8) and is conducted using an opt-out procedure.
Management information
Registered date
| 2026 | Year | 10 | Month | 14 | Day |
Last modified on
| 2026 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072304
