UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059028 |
|---|---|
| Receipt number | R000067287 |
| Scientific Title | A Cohort Study on the Association Between Serum Erythropoietin Dynamics and Prognosis in Patients with Metastatic Renal Cell Carcinoma Treated with Belzutifan |
| Date of disclosure of the study information | 2025/10/15 |
| Last modified on | 2025/09/08 14:40:43 |
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Basic information
Public title
A Cohort Study on the Association Between Serum Erythropoietin Dynamics and Prognosis in Patients with Metastatic Renal Cell Carcinoma Treated with Belzutifan
Acronym
A Cohort Study on the Association Between Serum Erythropoietin Dynamics and Prognosis in Patients with Metastatic Renal Cell Carcinoma Treated with Belzutifan
Scientific Title
A Cohort Study on the Association Between Serum Erythropoietin Dynamics and Prognosis in Patients with Metastatic Renal Cell Carcinoma Treated with Belzutifan
Scientific Title:Acronym
A Cohort Study on the Association Between Serum Erythropoietin Dynamics and Prognosis in Patients with Metastatic Renal Cell Carcinoma Treated with Belzutifan
Region
| Japan |
Condition
Condition
renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between serum erythropoietin (EPO) dynamics during belzutifan therapy and treatment outcomes (progression-free survival) as well as adverse events (anemia and hypoxia) in patients with metastatic or advanced renal cell carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-Free Survival
Key secondary outcomes
Overall survival
Time to onset of anemia
Time to onset of hypoxia, based on SpO2 measurements or clinical diagnosis
Occurrence and timing of treatment interruption or dose reduction due to anemia or hypoxia
Incidence of adverse events
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
Patients with a pathological diagnosis of renal cell carcinoma who are receiving treatment with belzutifan
Age >= 20 years
Written informed consent obtained from the patient
Key exclusion criteria
Patients concurrently receiving anticancer therapy for another malignancy (except hormonal therapy for prostate cancer)
Patients with severe cardiopulmonary disease or uncontrolled infections
Patients deemed inappropriate for study participation by the principal investigator
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Takuto |
| Middle name | |
| Last name | Hara |
Organization
Kobe University Graduate School of Medicine
Division name
Division
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL
0783826155
urokobe@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuto |
| Middle name | |
| Last name | Hara |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Urology
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku
TEL
0783826155
Homepage URL
urokobe@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
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
Kobe University Clinical Research Ethical Committee
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
Tel
0783826669
cerb@med.kobe-u.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
| 2025 | Year | 10 | Month | 15 | 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
| 2025 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the association between serum erythropoietin (EPO) fluctuations during treatment and treatment efficacy (progression-free survival) as well as the occurrence of adverse events (anemia and hypoxia) in patients with metastatic or advanced renal cell carcinoma receiving Bellsufan.
Management information
Registered date
| 2025 | Year | 09 | Month | 08 | Day |
Last modified on
| 2025 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067287
