Safety and Effect of Low-Energy Extracorporeal Shockwave Therapy (ESWT) on the Renal Allograft in Transplant Recipients.
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|ClinicalTrials.gov Identifier: NCT03602807|
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Transplant Dysfunction||Device: Extracorporeal Shockwave Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Effect of Low-Energy Extracorporeal Shockwave Therapy (ESWT) on the Renal Allograft in Transplant Recipients - a Pilot Study.|
|Actual Study Start Date :||February 26, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
|Experimental: Active treatment||
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"
- Change in renal clearance (GFR) [ Time Frame: At baseline and 3 months after treatment ]Comparing GFR before and 3 months after treatment sessions
- Change in albumin/creatine ratio in 24hour urine sample [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602807
|Contact: Ronja N Lundrup, BSc.med||+45 40 76 40 firstname.lastname@example.org|
|Contact: Lars Lund, Professor, MDemail@example.com|
|Odense University Hospital||Recruiting|
|Odense, Region Of Southern Denmark, Denmark, 5000|
|Contact: Ronja N Lundrup, BSc.med +45 40 76 40 05 firstname.lastname@example.org|