Renal InsufficiencyNCT04119427
The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal Insufficiency After Renal Transplantation
A study testing ultrasonic therapeutic apparatus 1 and ultrasonic therapeutic apparatus 2 in people with Renal Insufficiency and Renal Transplantation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The safety and efficacy of micro-energy ultrasound in the treatment of renal insufficiency after renal transplantation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Renal Insufficiency, Renal Transplantation
- What is being tested?
- ultrasonic therapeutic apparatus 1 and ultrasonic therapeutic apparatus 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- More than half a year after renal transplantation, serum creatinine elevated over three times , patients with ineffective immunosuppressive drugs;
- Mild to moderate renal insufficiency (creatinine less than 442umol / L);
- Volunteer to participate in this clinical trial, comply with the requirements of this clinical trial and sign the informed consent form.
Who cannot join
- Patients with severe renal insufficiency;
- Blood routine suggests acute and chronic blood system diseases;
- B-ultrasound suggests transplanting hydronephrosis;
- Uncontrollable patients with diabetes, hypertension, and cardiovascular disease;
- The investigator determined that it is not suitable for this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Jiaquan Xiao, Dr., +86-571-87783550, jiaquanxiao@163.com
About this study
Official title: The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal Insufficiency After Renal Transplantation: A Multicenter, Randomized Clinical Trail
The safety and efficacy of micro-energy ultrasound in the treatment of renal insufficiency after renal transplantation.
Read the detailed description
- Study purposes: To evaluate the safety and efficacy of micro-energy ultrasound in the treatment of renal dysfunction after renal transplantation by measuring serum creatinine, urine volume, urea nitrogen, and transplanted kidney ultrasound, etc.
- Study design: This is a randomized, double-blind, controlled, multicenter clinical trial.
- Study objects: Patients with mild to moderate renal insufficiency after renal transplantation.
- Number of samples: 90
- Main study center: Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
- Treatments:
Test group: After installing the disposable treatment head coat, the transplanted kidney was treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed.Patients were treated twice a week for 6 weeks.
Control group: The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
- Conditions
- Renal Insufficiency, Renal Transplantation
- Being tested
- ultrasonic therapeutic apparatus 1, ultrasonic therapeutic apparatus 2
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonic therapeutic apparatus 1Device
After installing the disposable treatment head coat, the transplanted kidney was treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks.
ultrasonic therapeutic apparatus 2Device
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | After installing the disposable treatment head coat, the transplanted kidney was treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks. Receives: Device: ultrasonic therapeutic apparatus 1 |
| Control Group | Placebo comparator | The placebo was treated with an ultrasound therapy device and used in the same manner as the test group. Receives: Device: ultrasonic therapeutic apparatus 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the patient'serum creatinine by a biochemical analyzer
Measuring the patient'serum creatinine by a biochemical analyzer
Measured: within 3 months after surgery
Manually record the patient's urine volume in 24 hours by a measuring glass
Manually record the patient's urine volume in 24 hours by a measuring glass
Measured: within 3 months after surgery
Measuring the patient'urea nitrogen by a biochemical analyzer
Measuring the patient'urea nitrogen by a biochemical analyzer
Measured: within 3 months after surgery
Secondary outcomes (1)
Monitoring the blood flow of the transplanted kidney by a doppler ultrasound
Monitoring the blood flow of the transplanted kidney by a doppler ultrasound
Measured: within 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 May 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, First Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119427
- Sponsor's protocol ID
- 2019-194
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal Insufficiency After Renal Transplantation: A Multicenter, Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT04119427
- Acronym / sponsor ID
- 2019-194
- Conditions
- Renal Insufficiency, Renal Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, First Affiliated Hospital of Wenzhou Medical University
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The safety and efficacy of micro-energy ultrasound in the treatment of renal insufficiency after renal transplantation.
Detailed description
- Study purposes: To evaluate the safety and efficacy of micro-energy ultrasound in the treatment of renal dysfunction after renal transplantation by measuring serum creatinine, urine volume, urea nitrogen, and transplanted kidney ultrasound, etc.
- Study design: This is a randomized, double-blind, controlled, multicenter clinical trial.
- Study objects: Patients with mild to moderate renal insufficiency after renal transplantation.
- Number of samples: 90
- Main study center: Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
- Treatments:
Test group: After installing the disposable treatment head coat, the transplanted kidney was treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed.Patients were treated twice a week for 6 weeks.
Control group: The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: ultrasonic therapeutic apparatus 1After installing the disposable treatment head coat, the transplanted kidney was treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks. |
| Control Group | Placebo comparator | Device: ultrasonic therapeutic apparatus 2The placebo was treated with an ultrasound therapy device and used in the same manner as the test group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- More than half a year after renal transplantation, serum creatinine elevated over three times , patients with ineffective immunosuppressive drugs;
- Mild to moderate renal insufficiency (creatinine less than 442umol / L);
- Volunteer to participate in this clinical trial, comply with the requirements of this clinical trial and sign the informed consent form.
Key exclusion criteria (5 listed)
- Patients with severe renal insufficiency;
- Blood routine suggests acute and chronic blood system diseases;
- B-ultrasound suggests transplanting hydronephrosis;
- Uncontrollable patients with diabetes, hypertension, and cardiovascular disease;
- The investigator determined that it is not suitable for this clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonic therapeutic apparatus 1After installing the disposable treatment head coat, the transplanted kidney was treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks. | Device | Test Group |
| ultrasonic therapeutic apparatus 2The placebo was treated with an ultrasound therapy device and used in the same manner as the test group. | Device | Control Group |
Primary outcome
Measuring the patient'serum creatinine by a biochemical analyzer
Time frame: within 3 months after surgery
Measuring the patient'serum creatinine by a biochemical analyzer
Manually record the patient's urine volume in 24 hours by a measuring glass
Time frame: within 3 months after surgery
Manually record the patient's urine volume in 24 hours by a measuring glass
Measuring the patient'urea nitrogen by a biochemical analyzer
Time frame: within 3 months after surgery
Measuring the patient'urea nitrogen by a biochemical analyzer
1 secondary outcome
Monitoring the blood flow of the transplanted kidney by a doppler ultrasound
Time frame: within 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonic therapeutic apparatus 1 and ultrasonic therapeutic apparatus 2 in people with Renal Insufficiency and Renal Transplantation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiaquan Xiao, Dr. (+86-571-87783550, jiaquanxiao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the patient'serum creatinine by a biochemical analyzer (time frame: within 3 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.