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

Not Applicable

• Conditions: Transplant Dysfunction
• Interventions: Device: Extracorporeal Shockwave Therapy

• Registration Number: NCT03602807
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-26
• Study First Submitted: 2018-06-19
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-26
• Last Update Submitted: 2018-07-26
• Study First Posted: 2018-07-27
• Last Update Posted: 2018-07-27
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active treatment	Extracorporeal Shockwave Therapy	-

Primary Outcome Measures

Name	Time	Method
Change in renal clearance (GFR)	At baseline and 3 months after treatment	Comparing GFR before and 3 months after treatment sessions

Secondary Outcome Measures

Name	Time	Method
Change in albumin/creatine ratio in 24hour urine sample	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.
Incidens of treatment-related adverse events	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.

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Region Of Southern Denmark, Denmark