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Low Energy Shockwave Therapy (LE-SWT): A Novel Treatment for Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT02515461
Recruitment Status : Recruiting
First Posted : August 4, 2015
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Sune Moeller Jeppesen, Odense University Hospital

Brief Summary:

The investigators aim to investigate whether low energy shockwave therapy (LE-SWT) can preserve kidney function in diabetic patients. Participants in this study will receive LE-SWT treatment 6 times over 3 weeks. The treatment is non-invasive and has no known side effects. Previous studies have shown that LE-SWT induces angiogenesis. The investigators hypothesize that chromium-ethylenediaminetetraacetic acid (EDTA) renal clearance remains stable or increases in treated patients. Furthermore, kidney biopsy should show no signs of damage to the tissue and possibly neo-vascularization. In this project, the investigators shall also investigate LE-SWT effect on urinary markers of tubular damage and urinary nitric oxide indices. Patients' self-reported quality of life will be assessed using Short Form 36 version 2 (SF-36v2) Health Survey.

There is an 18-months follow-up on patients. Only patients between 18-65 years old with moderate chronic kidney failure from diabetes will be included.

This project is an interventional prospective study. 30 patients with moderate kidney failure will be recruited from the Department of Endocrinology, Odense University Hospital, Denmark. LE-SWT treatment will be performed in the ambulatory of Department of Urology. Patients will be hospitalized for 1 day in the Department of Nephrology when kidney biopsy is taken (two times in study period).


Condition or disease Intervention/treatment Phase
Diabetic Nephropathies Device: Low energy shockwave therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Energy Shockwave Therapy (LE-SWT): A Novel Treatment for Chronic Kidney Disease
Study Start Date : July 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Intervention: Low energy shockwave therapy
Low energy shockwave therapy performed on both kidneys applying 3000 shocks on each kidney.
Device: Low energy shockwave therapy

Procedure: The patient lies on supine position during treatment. Kidney will be localised in line ultrasound. 3000 shockwaves at a frequency of 4 Hz are applied to each kidney per session. The kidney will be divided into three treatment areas including 1000 shockwaves applied to each treatment area.

Patients will receive 6 sessions over 3 weeks. Treatments are carried out on day 1, day 3, day 7, day 10, day 14, and day 17 after enrollment (average time points).

Treatment is performed using the MODULITH SLX-F2, manufactured by STORZ MEDICAL AG.





Primary Outcome Measures :
  1. Chromium-EDTA clearance [ Time Frame: 19 months after enrollment (average time point). ]
    Measurement compared to chromium-EDTA clearance prior to intervention

  2. Histological assessment of endothelial growth in kidneys [ Time Frame: 19 months after enrollment (average time point). ]
    Semi-quantitative determination of endothelium in kidney biopsy.

  3. Nitrite, nitrate and cGMP concentrations in spot urine sample (composite outcome) [ Time Frame: 19 months after enrollment (average time point). ]
    Quantitative measurements of nitric oxide indices in urine

  4. Neutrophil Gelatinase-Associated Lipocalin (NGAL) concentration in spot urine sample. [ Time Frame: 2 months after enrollment (average time point). ]
    Assessment of tubular damage in kidneys

  5. Patient-reported quality of life [ Time Frame: 19 monts after enrollment (average time point). ]
    SF-36v2 Health Survey scores

  6. Albumin/creatinin ratio in spot urine sample [ Time Frame: 2 months after enrollment (average time point). ]
    Assessment of glomerular damage in kidneys

  7. Histological assessment of fibrosis in kidney biopsy [ Time Frame: 19 months after enrollment (average time point). ]
    Semi-quantitative determination of fibrotic tissue in kidney biopsy.

  8. Changes in glomerulus basal lamina assessed using transmission electron microscopy. [ Time Frame: 19 months after enrollment (average time point). ]
    Qualitative analysis of glomerulus basal lamina using transmission electron microscopy.


Secondary Outcome Measures :
  1. Chromium-EDTA clearance [ Time Frame: 4 months and 7 months after enrollment (average time points). ]
    Measurement compared to chromium-EDTA clearance prior to intervention

  2. Nitrite, nitrate and cGMP concentrations in spot urine sample (composite outcome). [ Time Frame: Day 1, day 3, day 7, day 10, day 14, and day 17 after enrollment (average time points). Furthermore: 2 months, 4 months, 7 months, 10 months, 13 months, and 16 months after enrollment (average time points). ]
    Quantitative measurements of nitric oxide indices in urine

  3. Neutrophil Gelatinase-Associated Lipocalin (NGAL) concentration in spot urine sample. [ Time Frame: Day 1, day 3, day 7, day 10, day 14, and day 17 after enrollment (average time points). ]
    Assessment of tubular damage in kidneys

  4. Albumin/creatinin ratio in spot urine sample [ Time Frame: Day 1, day 3, day 7, day 10, day 14, and day 17 after enrollment (average time points). ]
    Assessment of glomerular damage in kidneys

  5. Patient-reported quality of life [ Time Frame: 10 months after enrollment (average time point). ]
    SF-36v2 Health Survey scores

  6. 24 hour blood pressure monitoring [ Time Frame: 2 months, 4 months, 7 months, and 19 months after enrollment (average time points). ]
  7. Haematoma in kidney [ Time Frame: 2 months, 7 months, and 13 months after enrollment (average time points). ]
    Ultrasound investigation of kidney for haematoma and/or other structural changes. This is a qualitative investigation.

  8. Blood creatinine concentration (estimated glomerular filtration rate) [ Time Frame: 2 months, 4 months, 7 months, 10 months, 13 months, 16 months, and 19 months after enrollment (average time points). ]
    Measurement of creatinine concentration in blood sample (estimated glomerular filtration rate).

  9. Blood urea concentration [ Time Frame: 2 months, 4 months, 7 months, 10 months, 13 months, 16 months, and 19 months after enrollment (average time points). ]
    Measurement of urea concentration in blood sample.

  10. Albumin/creatinin ratio in urine [ Time Frame: 2 months, 4 months, 7 months, and 19 months after enrollment (average time points). ]
    Measurement of albumin/creatinine ratio in 24 hour urine sample

  11. Protein concentration in urine [ Time Frame: 2 months, 4 months, 7 months, and 19 months after enrollment (average time points). ]
    Measurement of protein excretion in 24 hour urine sample



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CKD stage 3: Moderate reduction in GFR in patients with diabetes mellitus (DM)

Exclusion Criteria:

  • CKD stage 1, 2, 4, 5.
  • Blood pressure above 140/90 mmHg
  • Renography with less than 30 % differential function on one kidney
  • Kidney or ureteric stone
  • Obstructive uropathy
  • Kidney tumor
  • Chronic Urinary Tract Infection (UTI)
  • Single kidney
  • Bleeding disorders (coagulopathy)
  • Patient on anticoagulants
  • Coronary infarction during study period
  • LE-SWT for other reasons and non-diabetes mellitus kidney disease
  • Severe psychiatric disorder
  • Kidney transplant recipient
  • 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): NCT02515461


Contacts
Contact: Sune M Skov-Jeppesen, MD 0045 51210911 sune.jeppesen@rsyd.dk
Contact: Lars Lund, Professor lars.lund@rsyd.dk

Locations
Denmark
Odense Universitetshospital Recruiting
Odense, Denmark, 5000
Contact: Sune M Skov-Jeppesen, MD    0045 51210911    sune.jeppesen@rsyd.dk   
Contact: Lars Lund, Professor       lars.lund@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital
Investigators
Study Director: Lars Lund, Professor Odense University Hospital

Responsible Party: Sune Moeller Jeppesen, BSc.med, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02515461     History of Changes
Other Study ID Numbers: 2015_LEST_KIDNEY
First Posted: August 4, 2015    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Keywords provided by Sune Moeller Jeppesen, Odense University Hospital:
Diabetes mellitus
Low energy shockwave therapy
Chronic Renal Insufficiency

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Diabetic Nephropathies
Urologic Diseases
Renal Insufficiency
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases