UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061159 |
|---|---|
| Receipt number | R000069542 |
| Scientific Title | A Prospective Interventional Study Evaluating the Renoprotective Effects of Dapagliflozin in Kidney Transplant Recipients |
| Date of disclosure of the study information | 2026/04/04 |
| Last modified on | 2026/04/04 16:04:37 |
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Basic information
Public title
A prospective intervention study to investigate the renal function protective effect of dapagliflozin in kidney transplant recipients
Acronym
A prospective intervention study to investigate the renal function protective effect of dapagliflozin in kidney transplant recipients
Scientific Title
A Prospective Interventional Study Evaluating the Renoprotective Effects of Dapagliflozin in Kidney Transplant Recipients
Scientific Title:Acronym
A Prospective Interventional Study Evaluating the Renoprotective Effects of Dapagliflozin in Kidney Transplant Recipients
Region
| Japan |
Condition
Condition
Kidney Transplant Recipients
Classification by specialty
| Nephrology | Urology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of dapagliflozin on renal function in kidney transplant patients and evaluate its potential to improve the long-term prognosis of transplanted kidneys
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
decline in eGFR
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
oral dapagliflozin
Interventions/Control_2
without dapagliflozin
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
eGFR 25mL/min/1.73 m2 or more and urine protein 0.2g/gCr or more
Key exclusion criteria
Patients prone to hypoglycemia/dehydration
Patients with malnutrition
Pregnant/nursing women
Active infection (including a history of urinary tract infection)
Immune rejection within the past 6 months
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | KAORU |
| Middle name | |
| Last name | YASUDA |
Organization
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Division name
Nephrology
Zip code
4538511
Address
3-35 Michisita-cho, Nakamura-ku, Nagoya city
TEL
0524815111
nagoya1st.redcross.yk@gmail.com
Public contact
Name of contact person
| 1st name | KAORU |
| Middle name | |
| Last name | YASUDA |
Organization
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Division name
Nephrology
Zip code
4538511
Address
3-35 Michisita-cho, Nakamura-ku, Nagoya city
TEL
0524815111
Homepage URL
nagoya1st.redcross.yk@gmail.com
Sponsor or person
Institute
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Address
3-35 Michisita-cho, Nakamura-ku, Nagoya city
Tel
0524815111
nagoya1st.redcross.yk@gmail.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
| 2026 | Year | 04 | Month | 04 | 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
62
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
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 04 | Day |
Last modified on
| 2026 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069542
