The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal Insufficiency After Renal Transplantation
1 other identifier
interventional
90
1 country
1
Brief Summary
The safety and efficacy of micro-energy ultrasound in the treatment of renal insufficiency after renal transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2019
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMay 12, 2020
October 1, 2019
1.7 years
October 2, 2019
May 9, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Measuring the patient'serum creatinine by a biochemical analyzer
Measuring the patient'serum creatinine by a biochemical analyzer
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
within 3 months after surgery
Measuring the patient'urea nitrogen by a biochemical analyzer
Measuring the patient'urea nitrogen by a biochemical analyzer
within 3 months after surgery
Secondary Outcomes (1)
Monitoring the blood flow of the transplanted kidney by a doppler ultrasound
within 3 months after surgery
Study Arms (2)
Test Group
EXPERIMENTALAfter 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 COMPARATORThe placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
Interventions
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.
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2019
First Posted
October 8, 2019
Study Start
May 1, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
May 12, 2020
Record last verified: 2019-10