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

Odense University Hospital

Status: Unknown

Conditions: Transplant Dysfunction

Treatments: Device: Extracorporeal Shockwave Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03602807

ESWT-tx

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Active treatment

Experimental group

Treatment:

Device: Extracorporeal Shockwave Therapy