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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03602807

Enrollment

Registered

2018-07-27

Start date

2018-02-26

Completion date

2020-01-31

Last updated

2018-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplant Dysfunction

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.

Interventions

DEVICEExtracorporeal 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Denmark

Contacts

Primary ContactRonja N Lundrup, BSc.med

rolun13@student.sdu.dk+45 40 76 40 05

Backup ContactLars Lund, Professor, MD

lars.lund@rsyd.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026