The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal Insufficiency After Renal Transplantation

Renal Insufficiency Clinical Trial

Official title:

The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal Insufficiency After Renal Transplantation: A Multicenter, Randomized Clinical Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04119427
• Other study ID #: 2019-194
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jiaquan Xiao, Dr.
• Phone: +86-571-87783550
• Email: jiaquanxiao[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The safety and efficacy of micro-energy ultrasound in the treatment of renal insufficiency after renal transplantation.

Description:

1. 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.

2. Study design: This is a randomized, double-blind, controlled, multicenter clinical trial.

3. Study objects: Patients with mild to moderate renal insufficiency after renal transplantation.

4. Number of samples: 90

5. Main study center: Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.

6. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. More than half a year after renal transplantation, serum creatinine elevated over three times , patients with ineffective immunosuppressive drugs;

2. Mild to moderate renal insufficiency (creatinine less than 442umol / L);

3. Volunteer to participate in this clinical trial, comply with the requirements of this clinical trial and sign the informed consent form.

Exclusion Criteria:

1. Patients with severe renal insufficiency;

2. Blood routine suggests acute and chronic blood system diseases;

3. B-ultrasound suggests transplanting hydronephrosis;

4. Uncontrollable patients with diabetes, hypertension, and cardiovascular disease;

5. The investigator determined that it is not suitable for this clinical trial.

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Transplantation

Intervention

Device:
• ultrasonic therapeutic apparatus 1
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 2
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	First Affiliated Hospital of Wenzhou Medical University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring the patient'serum creatinine by a biochemical analyzer	Measuring the patient'serum creatinine by a biochemical analyzer	within 3 months after surgery
Primary	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
Primary	Measuring the patient'urea nitrogen by a biochemical analyzer	Measuring the patient'urea nitrogen by a biochemical analyzer	within 3 months after surgery
Secondary	Monitoring the blood flow of the transplanted kidney by a doppler ultrasound	Monitoring the blood flow of the transplanted kidney by a doppler ultrasound	within 3 months after surgery