UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042378 |
|---|---|
| Receipt number | R000048324 |
| Scientific Title | Prospective randomized trial of antibiotic prophylaxis in renal biopsy |
| Date of disclosure of the study information | 2020/11/07 |
| Last modified on | 2022/11/27 15:32:10 |
* 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
Prospective randomized trial of antibiotic prophylaxis in renal biopsy
Acronym
Prospective randomized trial of antibiotic prophylaxis in renal biopsy
Scientific Title
Prospective randomized trial of antibiotic prophylaxis in renal biopsy
Scientific Title:Acronym
Prospective randomized trial of antibiotic prophylaxis in renal biopsy
Region
| Japan |
Condition
Condition
kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
verifying whether the administration of antibiotic prophylaxis can be discontinued in renal biopsy
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the number of patients with positive urine cultures in 3 or 4 days after renal biopsy (more than 10 to the 5th power colony forming unit/ml) , or when the patient is diagnosed with pyelonephritis within two or three days after renal biopsy
Key secondary outcomes
the number of patients who had a diagnosis of pyelonephritis within 30 days after renal biopsy
the number of patients that who had a diagnosis of puncture site infection within 30 days after renal biopsy
the number of patients who had a diagnosis of the infection except pyelonephritis and puncture site infection within 30 days after renal biopsy
the number of patients who caused the side effect of antibiotic prophylaxis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
administration of antibiotic prophylaxis
Interventions/Control_2
not administration of antibiotic prophylaxis
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo percutaneous renal biopsy
Key exclusion criteria
Patients who present with a white blood cell count of >10/high-power field (HPF) on two occasions during the most recent urinalysis (including once within 3 days of the procedure)
patients with allergy to cefazolin
patients who received antibiotics administration within seven days before renal biopsy
patients who were inserted urethral catheters in the day before from 7 days before renal biopsy
patients with human immunodeficiency virus infection
patients with pregnancy
Target sample size
364
Research contact person
Name of lead principal investigator
| 1st name | Kensei |
| Middle name | |
| Last name | Yahata |
Organization
Osaka Red Cross Hospital
Division name
Department of Nephrology
Zip code
543-8555
Address
5-30, Fudegasaki-cho, Tennoji-ku, Osaka
TEL
06-6774-5111
kenseiyahata@osaka-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Kensei |
| Middle name | |
| Last name | Yahata |
Organization
Osaka Red Cross Hospital
Division name
Department of Nephrology
Zip code
543-8555
Address
5-30, Fudegasaki-cho, Tennoji-ku, Osaka
TEL
06-6774-5111
Homepage URL
kenseiyahata@osaka-med.jrc.or.jp
Sponsor or person
Institute
Osaka Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto University Hospital
Kitano Hospital
National Hospital Organization Kyoto Medical Center
Kyoto Min-Iren Chuo Hospital
Kobe City Medical Center General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Red Cross Hospital
Address
5-30, Fudegasaki-cho, Tennoji-ku, Osaka
Tel
06-6774-5111
soumudaiichi@osaka-med.jrc.or.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
| 2020 | Year | 11 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 07 | Day |
Last modified on
| 2022 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048324
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
