Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal Shockwave Therapy | Device | 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" |
| Measure | Description | Time Frame |
|---|---|---|
| Change in renal clearance (GFR) | Comparing GFR before and 3 months after treatment sessions | At baseline and 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Incidens of treatment-related adverse events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ronja N Lundrup, BSc.med | Contact | +45 40 76 40 05 | rolun13@student.sdu.dk | |
| Lars Lund, Professor, MD | Contact | lars.lund@rsyd.dk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Recruiting | Odense | Region Syddanmark | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33131308 | Derived | Klomjit N, Lerman A, Lerman LO. It Comes As a Shock: Kidney Repair Using Shockwave Therapy. Hypertension. 2020 Dec;76(6):1696-1703. doi: 10.1161/HYPERTENSIONAHA.120.14595. Epub 2020 Nov 2. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |