UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030448 |
|---|---|
| Receipt number | R000034765 |
| Scientific Title | Low-power extracorporeal shock wave therapy for improvement of blood pressure and suppression of renal function reduction in CKD patients diagnosed as chronic kidney disease (CKD) stage 3, 4 |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2017/12/18 15:22:40 |
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Basic information
Public title
Low-power extracorporeal shock wave therapy for improvement of blood pressure and suppression of renal function reduction in CKD patients diagnosed as chronic kidney disease (CKD) stage 3, 4
Acronym
ESWT-CKD
Scientific Title
Low-power extracorporeal shock wave therapy for improvement of blood pressure and suppression of renal function reduction in CKD patients diagnosed as chronic kidney disease (CKD) stage 3, 4
Scientific Title:Acronym
ESWT-CKD
Region
| Japan |
Condition
Condition
CKD stage 3 &4 patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By using an extracorporeal shock wave device, we evaluate the effectiveness of low power extracorporeal shock wave therapy for improving blood pressure, an important risk factor of CKD progression, in CKD stage 3 &4 patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement of mean blood pressure
Key secondary outcomes
improvement of eGFR
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
| Device,equipment |
Interventions/Control_1
Extracorporeal Shock Wave
Interventions/Control_2
control
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
CKD stage 3 & 4 patients with at least one history of hypertension, diabetes, dyslipidemia, smoking history, cardiovascular complications
Key exclusion criteria
Patients with a local skin infection at the contact site with the applicator
Patients with bleeding tendency
Patients with urolithiasis or kidney stones
Patients with hydronephrosis
Patients with active pyelonephritis
Patients with cancer
Patients treated with steroids or immunosuppressants
Patients who is expected to introduce dialysis within 12 weeks
Polycystic kidney disease patients
Patients with renal morphological abnormality
Patients who received kidney transplantation
Dialysis patients (HD, PD)
Patients whose renal blood flow cannot be evaluated
Objects considered by the attending physician as inappropriate
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Isaka |
Organization
Osaka University Graduate School of Medicine
Division name
Nephrology
Zip code
Address
2-2, Yamadaoka, Suita
TEL
0668793857
isaka@kid.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Isaka |
Organization
Osaka University Graduate School of Medicine
Division name
Nephrology
Zip code
Address
2-2, Yamadaoka, Suita
TEL
0668793857
Homepage URL
isaka@kid.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 04 | 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
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 18 | Day |
Last modified on
| 2017 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034765
