NCT02515461

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

6.5 years

First QC Date

July 27, 2015

Last Update Submit

March 5, 2020

Conditions

Diabetic Nephropathies

Keywords

Diabetes mellitusLow energy shockwave therapyChronic Renal Insufficiency

Outcome Measures

Primary Outcomes (8)

  • Chromium-EDTA clearance

    Measurement compared to chromium-EDTA clearance prior to intervention

    19 months after enrollment (average time point).

  • Histological assessment of endothelial growth in kidneys

    Semi-quantitative determination of endothelium in kidney biopsy.

    19 months after enrollment (average time point).

  • Nitrite, nitrate and cGMP concentrations in spot urine sample (composite outcome)

    Quantitative measurements of nitric oxide indices in urine

    19 months after enrollment (average time point).

  • Neutrophil Gelatinase-Associated Lipocalin (NGAL) concentration in spot urine sample.

    Assessment of tubular damage in kidneys

    2 months after enrollment (average time point).

  • Patient-reported quality of life

    SF-36v2 Health Survey scores

    19 monts after enrollment (average time point).

  • Albumin/creatinin ratio in spot urine sample

    Assessment of glomerular damage in kidneys

    2 months after enrollment (average time point).

  • Histological assessment of fibrosis in kidney biopsy

    Semi-quantitative determination of fibrotic tissue in kidney biopsy.

    19 months after enrollment (average time point).

  • Changes in glomerulus basal lamina assessed using transmission electron microscopy.

    Qualitative analysis of glomerulus basal lamina using transmission electron microscopy.

    19 months after enrollment (average time point).

Secondary Outcomes (11)

  • Chromium-EDTA clearance

    4 months and 7 months after enrollment (average time points).

  • Nitrite, nitrate and cGMP concentrations in spot urine sample (composite outcome).

    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).

  • Neutrophil Gelatinase-Associated Lipocalin (NGAL) concentration in spot urine sample.

    Day 1, day 3, day 7, day 10, day 14, and day 17 after enrollment (average time points).

  • Albumin/creatinin ratio in spot urine sample

    Day 1, day 3, day 7, day 10, day 14, and day 17 after enrollment (average time points).

  • Patient-reported quality of life

    10 months after enrollment (average time point).

  • +6 more secondary outcomes

Study Arms (1)

Intervention: Low energy shockwave therapy

EXPERIMENTAL

Low energy shockwave therapy performed on both kidneys applying 3000 shocks on each kidney.

Device: Low energy shockwave therapy

Interventions

Low energy shockwave therapyDEVICE

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.

Intervention: Low energy shockwave therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense Universitetshospital

Odense, 5000, Denmark

RECRUITING

Related Publications (2)

  • Vestersager SV, Skov-Jeppesen SM, Yderstraede KB, Bistrup C, Jensen BL, Lund L. Low-intensity extracorporeal shockwave therapy in patients with diabetic kidney disease: a matched cohort study. Int Urol Nephrol. 2025 Jul;57(7):2245-2253. doi: 10.1007/s11255-025-04379-4. Epub 2025 Feb 12.

    PMID: 39934556DERIVED

  • 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

Conditions

Diabetic NephropathiesDiabetes MellitusRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lars Lund, Professor

    Odense University Hospital

    STUDY DIRECTOR

Central Study Contacts

Sune M Skov-Jeppesen, MD

CONTACT

0045 51210911sune.jeppesen@rsyd.dk

Lars Lund, Professor

CONTACT

lars.lund@rsyd.dk

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
BSc.med

Study Record Dates

First Submitted

July 27, 2015

First Posted

August 4, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

March 6, 2020

Record last verified: 2020-03

Locations

DK(1)