Safety and Effect of Low-Energy Extracorporeal Shockwave Therapy (ESWT) on the Renal Allograft in Transplant Recipients.

July 26, 2018 updated by: Ronja Niemann Lundrup, Odense University Hospital

Safety and Effect of Low-Energy Extracorporeal Shockwave Therapy (ESWT) on the Renal Allograft in Transplant Recipients - a Pilot Study.

The aim is to investigate the safety and potential effect of Low-energy Shockwave Therapy (ESWT) on the transplanted kidney. The treatment consist of ESWT two times a week for three weeks, six treatments in total.

The hypothesis is that ESWT with improve the renal function, by reducing proteinuria (in a 24-hour urine collection test) and improving renal clearance of 51Cr-EDTA.

The safety of ESWT on the renal allograft will be assessed during and after treatments.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Of Southern Denmark
      • Odense, Region Of Southern Denmark, Denmark, 5000
        • Recruiting
        • Odense University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Minimum 1 year ago since last kidney transplant
  • P-Creatinin under 300, in the last 3 blood-samples
  • U-Albumine/creatinine ratio over 100, in the last 3 urine-samples

Exclusion Criteria:

  • Not Danish speaking.
  • Obstructive uropathy
  • Suspected autoimmune disease in the kidney graft
  • Symptomatic urinal tract infection (UTI)
  • Severe psychiatric disorder
  • Pregnant or planning on becoming pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active treatment
Device: Extracorporeal Shockwave Therapy

2 treatments a week for 3 weeks consisting of 3000 focused shockwaves of 4Hz and 0,20mJ/mm2 applied over the kidney allograft.

Treatment is performed using the STORZ DUOLITH® SD1 T-TOP "F-SW ultra"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in renal clearance (GFR)
Time Frame: At baseline and 3 months after treatment
Comparing GFR before and 3 months after treatment sessions
At baseline and 3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in albumin/creatine ratio in 24hour urine sample
Time Frame: At baseline, 1 month after treatment and 3 months after treatment
Comparing the results from a sample of 24-hour urine sample before, 1 month after and 3 months after treatment.
At baseline, 1 month after treatment and 3 months after treatment
Incidens of treatment-related adverse events
Time Frame: up to 4 months

The participants answer questions about side-effects before and after each treatment session, at 1 month followup and 3 month followup.

After 1 month a ultrasound of the kidney will show if there is any bleeding in the graft-tissue after the 6 treatments.
up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2018

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

June 19, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

July 27, 2018

Last Update Submitted That Met QC Criteria

July 26, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • ESWT-tx

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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