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

Transplant Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03602807
• Other study ID #: ESWT-tx
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: January 2020

Study information

• Verified date: July 2018
• Source: Odense University Hospital
• Contact: Ronja N Lundrup, BSc.med
• Phone: +45 40 76 40 05
• Email: rolun13[@]student.sdu.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transplant Dysfunction

Intervention

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"

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Region Of Southern Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in renal clearance (GFR)	Comparing GFR before and 3 months after treatment sessions	At baseline and 3 months after treatment
Secondary	Change in albumin/creatine ratio in 24hour urine sample	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
Secondary	Incidens of treatment-related adverse events	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