UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058351 |
|---|---|
| Receipt number | R000066708 |
| Scientific Title | Study on the long-term effects of renal damage in preeclampsia using serum hyaluronan, urinary podocalyxin, liver-type fatty acid-binding protein, and N-acetyl-beta-D-glucosaminidase measurements |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2025/07/02 22:28:06 |
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Basic information
Public title
Research on the long-term effects of renal damage in preeclampsia and the risk of future chronic kidney disease
Acronym
Research on renal damage in preeclampsia
Scientific Title
Study on the long-term effects of renal damage in preeclampsia using serum hyaluronan, urinary podocalyxin, liver-type fatty acid-binding protein, and N-acetyl-beta-D-glucosaminidase measurements
Scientific Title:Acronym
Study on the long-term effects of renal damage in preeclampsia based on serum and urine marker measurements
Region
| Japan |
Condition
Condition
Preeclampsia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The pathophysiology of preeclampsia (PE) is similar to that of chronic kidney disease (CKD), and epidemiological studies both domestically and internationally have pointed out that pregnant women with PE are more likely to develop CKD in the future. In our previous study, it was revealed that PE pregnant women experience damage to specific parts of the kidneys during pregnancy and within one month postpartum. The objective of this study is to clarify the long-term effects of kidney damage by conducting a long-term follow-up of PE pregnant women from the previous study, and to establish new insights into the future risk of CKD.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum hyaluronan (glycocalyx injury), urinary podocalyxin (podocyte injury), urinary liver-type fatty acid-binding protein (L-FABP) and N-acetyl-beta-D-glucosaminidase (NAG) (tubular injury) were measured at PE diagnosis and at 12 weeks postpartum.
Key secondary outcomes
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
This retrospective cohort study included preeclampsia (PE) women and normal pregnant women who delivered at Aichi Medical University Hospital between January 2022 and December 2024. PE is defined as hypertension developing after 20 weeks of gestation, accompanied by proteinuria.
Key exclusion criteria
Participants with multiple pregnancies, glucose metabolism disorders, renal complications, or systemic lupus erythematosus, two groups were identified for analysis are excluded.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazumasa |
| Middle name | |
| Last name | Sugiura |
Organization
Aichi Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
480-1195
Address
1-1 Iwasaku Karigata, Nagakute City, Aichi Prefecture
TEL
0561623311
sugiura.kazumasa.489@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Sugiura |
Organization
Aichi Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
480-1195
Address
1-1 Iwasaku Karigata, Nagakute City, Aichi Prefecture
TEL
0561623311
Homepage URL
sugiura.kazumasa.489@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
This work was supported in part by JSPS KAKENHI Grant Number. JK24K12544.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University
Address
1-1 Iwasaku Karigata, Nagakute City, Aichi Prefecture
Tel
0561623311
sugiura.kazumasa.489@mail.aichi-med-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 | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
138
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
| 2025 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Our results indicated that postpartum women with PE and prolonged proteinuria exhibited residual tubular dysfunction. Additionally, postpartum women with PE whose proteinuria resolves may still have residual glomerular damage at 12 weeks postpartum, by which time the effects of pregnancy are considered to have disappeared. These findings underscore the importance of long-term follow-up in postpartum women with PE to prevent them from overlooking the risk of developing postpartum CKD.
Management information
Registered date
| 2025 | Year | 07 | Month | 02 | Day |
Last modified on
| 2025 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066708
