UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050692 |
|---|---|
| Receipt number | R000057616 |
| Scientific Title | A retrospective study to evaluate the impact of proteinuria induced by Atezolizumab plus Bevacizumab on renal function and other renal-related adverse events in patients with unresectable hepatocellular carcinoma. |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/08/16 09:48:27 |
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Basic information
Public title
A retrospective study to evaluate the impact of proteinuria induced by Atezolizumab plus Bevacizumab on renal function and other renal-related adverse events in patients with unresectable hepatocellular carcinoma.
Acronym
Atezolizumab plus Bevacizumab-Related Impact on Renal Function and Adverse Events Trial
Scientific Title
A retrospective study to evaluate the impact of proteinuria induced by Atezolizumab plus Bevacizumab on renal function and other renal-related adverse events in patients with unresectable hepatocellular carcinoma.
Scientific Title:Acronym
Atezolizumab plus Bevacizumab-Related Impact on Renal Function and Adverse Events Trial
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The main purpose is to evaluate the impact of proteinuria induced by atezo+bev on renal function and other renal-related adverse events in patients with unresectable hepatocellular carcinoma.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between change in UPCR (urine protein/creatinine ratio) and change in eGFR from baseline.
Key secondary outcomes
(1)Correlation between change in urine dipstick test and change in eGFR from baseline
(2)Correlation of the score of UPCR / urine dipstick test and eGFR change at baseline
(3)Correlation of coexistence/occurrence of proteinuria and eGFR change
(4)Risk factors for renal function decline
(5)Risk factors for proteinuria
(6)Correlation between occurrence of adverse event and change in UPCR/ urine dipstick test
(7)Correlation between UPCR and urine dipstick test
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
(1)Patients who were treated Atezo+Bev for unresectable hepatocellular carcinoma between September 25, 2020 and May 31, 2022.
(2)Patients aged 18 years or older at the start of Atezo+Bev treatment
(3)Patients who have not declared their refusal during the period of this study and the documents regarding the use of existing information described in the protocol posted on the website of the Department of Gastroenterology, Kindai University School of Medicine
Key exclusion criteria
(1)Patients with missing UPCR and eGFR data at baseline
(2)Patients with all missing UPCR and eGFR data after starting Atezo+Bev treatment
(3)Patients with Child-Pugh Classification Class C at the start of Atezo+Bev treatment
(4)Patients deemed ineligible for this study by their physician
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kazuomi |
| Middle name | |
| Last name | Ueshima |
Organization
Kindai University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2, Oono-Higashi, Osaka-Sayama City, Osaka Prefecture, Japan
TEL
072-366-0221
kaz-ues@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Kazuomi |
| Middle name | |
| Last name | Ueshima |
Organization
Kindai University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2, Oono-Higashi, Osaka-Sayama City, Osaka Prefecture, Japan
TEL
072-366-0221
Homepage URL
kaz-ues@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine, Department of Gastroenterology and Hepatology
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
Ethics Committee, Kindai University Faculty of Medicine
Address
377-2, Oono-Higashi, Osaka-Sayama City, Osaka Prefecture, Japan
Tel
072-366-0221
zizen@med.kindai.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 | 03 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Outline of research methods
A retrospective study to investigate correlation of proteinuria and renal function induced by Atezolizumab and Bevacizumab for unresectable hepatocellular carcinoma.
2.Study design
Single center retrospective observational study
3.Inclusion/exclusion criteria for study subjects
Inclusion criteria
(1)Patients who were treated Atezo+Bev for unresectable hepatocellular carcinoma between September 25, 2020 and May 31x, 2022.
(2)Patients aged 18 years or older at the start of Atezo+Bev treatment
(3)Patients who have not declared their refusal during the period of this study and the documents regarding the use of existing information described in the protocol posted on the website of the Department of Gastroenterology, Kindai University School of Medicine.
exclusion criteria
(1)Patients with missing UPCR and eGFR data at baseline
(2)Patients with all missing UPCR and eGFR data after starting Atezo+Bev treatment
(3)Patients with Child-Pugh Classification Class C at the start of Atezo+Bev treatment
(4)Patients deemed ineligible for this study by their physician
Management information
Registered date
| 2023 | Year | 03 | Month | 28 | Day |
Last modified on
| 2023 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057616
