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

Primary Purpose

Renal Insufficiency, Renal Transplantation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ultrasonic therapeutic apparatus 1
ultrasonic therapeutic apparatus 2
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test Group

Control Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Measuring the patient'serum creatinine by a biochemical analyzer
Measuring the patient'serum creatinine by a biochemical analyzer
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
Measuring the patient'urea nitrogen by a biochemical analyzer
Measuring the patient'urea nitrogen by a biochemical analyzer

Secondary Outcome Measures

Monitoring the blood flow of the transplanted kidney by a doppler ultrasound
Monitoring the blood flow of the transplanted kidney by a doppler ultrasound

Full Information

First Posted
October 2, 2019
Last Updated
May 9, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, First Affiliated Hospital of Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04119427
Brief Title
The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal Insufficiency After Renal Transplantation
Official Title
The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal Insufficiency After Renal Transplantation: A Multicenter, Randomized Clinical Trail
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, First Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Renal Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
Intervention Type
Device
Intervention Name(s)
ultrasonic therapeutic apparatus 1
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ultrasonic therapeutic apparatus 2
Intervention Description
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
Primary Outcome Measure Information:
Title
Measuring the patient'serum creatinine by a biochemical analyzer
Description
Measuring the patient'serum creatinine by a biochemical analyzer
Time Frame
within 3 months after surgery
Title
Manually record the patient's urine volume in 24 hours by a measuring glass
Description
Manually record the patient's urine volume in 24 hours by a measuring glass
Time Frame
within 3 months after surgery
Title
Measuring the patient'urea nitrogen by a biochemical analyzer
Description
Measuring the patient'urea nitrogen by a biochemical analyzer
Time Frame
within 3 months after surgery
Secondary Outcome Measure Information:
Title
Monitoring the blood flow of the transplanted kidney by a doppler ultrasound
Description
Monitoring the blood flow of the transplanted kidney by a doppler ultrasound
Time Frame
within 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiaquan Xiao, Dr.
Phone
+86-571-87783550
Email
jiaquanxiao@163.com
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaquan Xiao, Dr.
Phone
+86-571-87783550
Email
jiaquanxiao@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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