UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050850 |
|---|---|
| Receipt number | R000057832 |
| Scientific Title | Association between Hypoxia Inducible Factor Prolyl Hydoxylase Inhibitor or Erythropoiesis-Stimulating Agents and Cardiovascular Disease: a retrospective cohort study with overlap propensity score weighting |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2023/04/05 13:21:24 |
* 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
Association between Hypoxia Inducible Factor Prolyl Hydoxylase Inhibitor or Erythropoiesis-Stimulating Agents and Cardiovascular Disease: a retrospective cohort study with overlap propensity score weighting
Acronym
Association between HIF-PHIs or ESAs and CVD: a retrospective cohort study with overlap propensity score weighting
Scientific Title
Association between Hypoxia Inducible Factor Prolyl Hydoxylase Inhibitor or Erythropoiesis-Stimulating Agents and Cardiovascular Disease: a retrospective cohort study with overlap propensity score weighting
Scientific Title:Acronym
Association between HIF-PHIs or ESAs and CVD: a retrospective cohort study with overlap propensity score weighting
Region
| Japan |
Condition
Condition
Renal anemia
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to use a Japanese healthcare record database to investigate whether ULT in patients with asymptomatic hyperuricemia could reduce the development of CVD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The composite outcome of cardiovascular diseases including coronary artery disease (I210-4, I219), stroke (I600-11, I613-6, I619, I629-36, I638-9), heart failure (I500-1, I509, I110), atrial fibrillation (I480-4, I489)
Key secondary outcomes
all cause mortality, artery disease (I210-4, I219), stroke (I600-11, I613-6, I619, I629-36, I638-9), heart failure (I500-1, I509, I110), atrial fibrillation (I480-4, I489)
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
-Age >=18 years.
-Patients with at least one observation of eGFR < 60 ml/min/1.73 m2 in blood test data
-Received HIF-PH inhibitors or ESAs.
Key exclusion criteria
Patients without a six-month lookback period before the index date.
Patients with a diagnosis of CVD prior to the index date (date of first dose of HIF-PH inhibitor or ESA preparation) (see primary endpoint for definition).
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Hashimoto |
Organization
Graduate School of Medicine and Public Health, Kyoto University
Division name
Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
TEL
0757539469
hashimoto.hiroyuki.36w@st.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Hashimoto |
Organization
Graduate School of Medicine and Public Health, Kyoto University
Division name
Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
TEL
0757539469
Homepage URL
hashimoto.hiroyuki.36w@st.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine and Public Health, Kyoto University
Institute
Department
Personal name
Hiroyuki Hashimoto
Funding Source
Organization
Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
0757534680
ethcom@kuhp.kyoto-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
| 2023 | Year | 09 | Month | 01 | 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
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1 Design
retrospective cohort study
2 Methods
2.1 Data source
The database is provided by JMDC Inc. This data set consists of records of medical check-ups and Japanese health insurance claims and medical checkups from several health insurance associations. The data was accumulated since 2005 and a cumulative population of approximately 14 million people (as of February 2022).
3 Observation, examination, survey and reporting items and schedule
3.1 Measurement items
date of birth, gender, smoking history, BMI, type of claims data, date of medical treatment, laboratory data, comorbidities, ICD10 codes, month when treatment started, year of treatment, outcome, ATC (Anatomical Therapeutic Chemical) classification code, date of prescription, etc.
Follow-up will start from the index date and end on the earliest of the following dates:
-Last visit to the relevant medical institution
-Death
-Last date of the data period of the provided dataset
-Discontinuation of HIF-PHI, ESA or crossover
(considered to be discontinuation after a three-month period of non-dosing)
4 Summary of analysis
4.1 Primary endpoints
Composite outcome of the following cardiovascular disease
-Coronary artery disease
-Stroke
-Heart failure
-Atrial fibrillation
4.2 Secondary endpoints
All-cause mortality, coronary artery disease, stroke, heart failure, atrial fibrillation
4.3 Main methods of analysis
The development of CVD is measured from the index date at which HIF-PHIs or ESAs were prescribed. A propensity score is calculated using logistic regression analysis and weighted using overlap weighting method. Explanatory variables will be used to calculate the propensity score. As the main analysis, data with missing values are excluded. In addition, Cox regression analysis will be performed to calculate the association between target drugs and CVD incidence. On-treatment analysis will be performed as the main analysis, where crossovers will be treated as censored cases.
Management information
Registered date
| 2023 | Year | 04 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057832
