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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
Sponsor:
Information provided by (Responsible Party):
Ronja Niemann Lundrup, Odense University Hospital

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.


Condition or disease Intervention/treatment Phase
Transplant Dysfunction Device: Extracorporeal Shockwave Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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"





Primary Outcome Measures :
  1. Change in renal clearance (GFR) [ Time Frame: At baseline and 3 months after treatment ]
    Comparing GFR before and 3 months after treatment sessions


Secondary Outcome Measures :
  1. 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.

  2. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Ronja N Lundrup, BSc.med +45 40 76 40 05 rolun13@student.sdu.dk
Contact: Lars Lund, Professor, MD lars.lund@rsyd.dk

Locations
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Denmark
Odense University Hospital Recruiting
Odense, Region Of Southern Denmark, Denmark, 5000
Contact: Ronja N Lundrup, BSc.med    +45 40 76 40 05    rolun13@student.sdu.dk   
Sponsors and Collaborators
Odense University Hospital

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Responsible Party: Ronja Niemann Lundrup, Undergraduate researcher, BSc.med, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03602807     History of Changes
Other Study ID Numbers: ESWT-tx
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No