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

NCT ID: NCT04119427

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Renal Insufficiency Renal Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

ultrasonic therapeutic apparatus 1

Intervention Type DEVICE

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.

Group Type PLACEBO_COMPARATOR

ultrasonic therapeutic apparatus 2

Intervention Type DEVICE

The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.

Interventions

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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.

Intervention Type DEVICE

ultrasonic therapeutic apparatus 2

The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiaquan Xiao, Dr.

Role: CONTACT

+86-571-87783550

Facility Contacts

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Jiaquan Xiao, Dr.

Role: primary

+86-571-87783550

Other Identifiers

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2019-194

Identifier Type: -

Identifier Source: org_study_id

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