Safety and Effect of Low-Energy Extracorporeal Shockwave Therapy (ESWT) on the Renal Allograft in Transplant Recipients.
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 26, 2018
CompletedFirst Submitted
Initial submission to the registry
June 19, 2018
CompletedFirst Posted
Study publicly available on registry
July 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJuly 27, 2018
July 1, 2018
1.8 years
June 19, 2018
July 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in renal clearance (GFR)
Comparing GFR before and 3 months after treatment sessions
At baseline and 3 months after treatment
Secondary Outcomes (2)
Change in albumin/creatine ratio in 24hour urine sample
At baseline, 1 month after treatment and 3 months after treatment
Incidens of treatment-related adverse events
up to 4 months
Study Arms (1)
Active treatment
EXPERIMENTALInterventions
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"
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Odense University Hospital
Odense, Region Syddanmark, 5000, Denmark
Related Publications (1)
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.
PMID: 33131308DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Undergraduate researcher, BSc.med
Study Record Dates
First Submitted
June 19, 2018
First Posted
July 27, 2018
Study Start
February 26, 2018
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
July 27, 2018
Record last verified: 2018-07