UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051620 |
|---|---|
| Receipt number | R000058872 |
| Scientific Title | A Study on the Risk of Fractures in Patients with Chronic Kidney Disease (CKD) Using the Japanese Medical Information Database. |
| Date of disclosure of the study information | 2023/07/15 |
| Last modified on | 2024/11/26 13:22:39 |
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Basic information
Public title
A Study on the Risk of Fractures in Patients with Chronic Kidney Disease (CKD) Using the Japanese Medical Information Database.
Acronym
A Study on the Risk of Fractures in Patients with Chronic Kidney Disease (CKD) Using the Japanese Medical Information Database.
Scientific Title
A Study on the Risk of Fractures in Patients with Chronic Kidney Disease (CKD) Using the Japanese Medical Information Database.
Scientific Title:Acronym
A Study on the Risk of Fractures in Patients with Chronic Kidney Disease (CKD) Using the Japanese Medical Information Database.
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the risk of bone fractures in patients with CKD in Japan using a receipts database.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone fracture
Key secondary outcomes
All-cause mortality
The implementation of bone density testing
Prescription of osteoporosis treatment drugs and medications related to bone metabolism
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 obtained eGFR measurements with a 2-point difference at intervals of 3 months or longer.
2) Age >=18 at index date
Key exclusion criteria
1) Patients with a confirmed diagnosis of cancer during the pre-index period.
2) Patients who underwent kidney transplantation or renal dialysis during the pre-index period.
3) Patients with a history of diseases related to decreased bone density or prescription history of osteoporosis drugs during the pre-index period.
4) Patients with a confirmed diagnosis of bone fractures during the pre-index period.
5) Patients who underwent blood sampling by a specific department (such as ICU/ER) on the index date.
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kimura |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Primary Medical Science Department
Zip code
103-0023
Address
3-5-1 Nihonbashi Honcho, Chuo-ku, Tokyo, Japan.
TEL
03-6225-1053
kimura.tetsuya.d2@daiichisankyo.co.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Shintani |
Organization
Osaka Metropolitan University
Division name
Department of Medical Statistics
Zip code
545-8585
Address
1-3-4 Asahimachi, Abeno-ku, Osaka, Japan.
TEL
06-6645-3894
Homepage URL
med-statacademy@ml.omu.ac.jp
Sponsor or person
Institute
Daiichi Sankyo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo 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
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3,Kichijoji-kitamachi,Musashino-shi,Tokyo,180-0001,Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.com
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 | 07 | Month | 15 | Day |
Related information
URL releasing protocol
https://link.springer.com/epdf/10.1007/s10157-024-02562-y?sharing_token=OObS1hOgf5r_KKc4GMuXz_e4RwlQ
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/epdf/10.1007/s10157-024-02562-y?sharing_token=OObS1hOgf5r_KKc4GMuXz_e4RwlQ
Number of participants that the trial has enrolled
76598
Results
1.Fracture incidence did not differ significantly between CKD and controls (5.7% vs. 5.8%; HR 1.022, 95% CI 0.952,1.098, P = 0.542).
2.Hip fracture risk was higher in CKD (1.7% vs. 1.3%; HR 1.415, 95% CI 1.234,1.622, P < 0.001).
3.Mortality was higher in CKD (HR 1.413, 95% CI 1.330,1.501, P < 0.001).
4.Osteoporosis treatment and BMD measurement rates were 10.0%, 5.3% in CKD vs.4.4%,4.4% in controls.
Results date posted
| 2024 | Year | 11 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study analyzed anonymized medical data collected between April 1, 2008, and April 30, 2023, targeting non-dialysis patients with CKD stages G3,4,5. The control group consisted of non-CKD patients matched by age and sex. A total of 76,598 individuals (38,299 per group) were included in the analysis.
At baseline, the mean age of participants was 72.3+/-12.7 years, with 76.5% aged 65 years or older and 67.0% being male. The most common comorbidities were hypertension (CKD group 70.4% vs. control group 49.8%), dyslipidemia (CKD group 44.2% vs. control group 43.8%), and diabetes (CKD group 43.7% vs. control group 41.7%). The mean eGFR in the CKD group was 33.8+/-14.4 mL/min/1.73m2, significantly lower than that in the control group (80.1+/-19.4 mL/min/1.73m2).
Participant flow
Participant Selection: Anonymized medical data collected between April 1, 2008, and April 30, 2023, were used to identify non-dialysis patients with CKD stages G3,4,5. A control group consisting of non-CKD patients matched by age and sex was selected.
Exclusion Criteria:
1.Patients without a diagnosis of CKD-related conditions within the past 3 months.
2.Patients with a history of kidney transplantation or fractures unrelated to renal disease.
3.Patients with insufficient follow-up during the data provision period.
Final Analysis Set: CKD group: 38,299 individuals. Control group: 38,299 individuals. Total: 76,598 individuals.
Adverse events
This study is a retrospective database study using DPC data, and there were no interventions or direct involvement with the participants. Therefore, no adverse events could occur.
Outcome measures
Outcomes included fracture incidence, mortality, and the implementation of bone metabolism-related treatments during the follow-up period.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A Study on the Risk of Fractures in Patients with Chronic Kidney Disease (CKD) Using the Japanese Medical Information Database.
Management information
Registered date
| 2023 | Year | 07 | Month | 15 | Day |
Last modified on
| 2024 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058872
