ClinicalTrials.gg
Status unknownNCT03445247Updated Feb 26, 2018

Extracorporeal Low-intensity Shockwave in Diabetic Nephropathy

An interventional study of Extracorporeal low-intensity shockwave in Diabetic Nephropathy Type 2, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-02-26.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jul 2017, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 21 studies in Diabetic Nephropathies with a site in Taiwan — 3 open to participants now, 3 under way, none of them phase 3. Diabetic Nephropathies · Taiwan.

Planned enrollment
15th of 17
60 · median 281
Started
2017
with 1 other
No phase
5 of 21
1 open now
Registered
13th of 21
by date
Lead sponsor
2 of 21
Chang Gung Memorial Hospital

Among the 21 studies in Diabetic Nephropathies with a site in Taiwan, this one is the 15th largest by planned enrollment of the 17 interventional ones, is one of 2 that started in 2017, is one of 5 with no phase, and was the 13th registered.

By phase

21 studies; the count open now beside each. This study's row is marked.

Phase 27 · 0 open
No phasethis study5 · 1 open
Observational4 · 2 open
Phase 33 · 0 open
Phase 42 · 0 open

By the year they started

First in 2003; this study’s year is marked. 2 started in 2017.

Size and results

Median enrollment 281 across the 17 interventional studies, 669 across the 4 observational. Of the 14 that completed or were terminated, 7 (50%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 21 studies in Diabetic Nephropathies with a site in Taiwan, or all of them as a file.
02

Study summary

In the current study, we use extracorporeal low-intensity shockwave therapy (ESWT) to treat on patients with type 2 diabetes in stage 3-4 chronic kidney disease and see whether it can improve the proteinuria, renal function, and blood pressure compared to baseline and control group.

Read the detailed description

Diabetic nephropathy is the major contributor to end stage renal disease worldwide. Extracorporeal shock wave treatments (ESWT) with low-intensity was reported to be beneficial in inducing cell regeneration and reducing inflammation and have been successfully used for bone fracture, cardiac ischemia, and erectile disorders. In this study, sixty patients with stage III \& IV (15\<=estimated glomerular filtration rate (eGFR)\<60 ml/min/1.73m2) will be recruited and allocated to control and experimental groups in a 1:1 ratio. In experiment group, a total of 1200 shockwaves, with low energy density 0.1mj/mm2 and a frequency of 120 shocks/min, will be applied per kidney per treatment session. The treatment will be given twice a week for 3 consecutive weeks, followed by 3 weeks of recess and an additional series of 6 sessions (totally 12 times). Patients in each group will be evaluated with eGFR, urine protein-creatinine ration, blood pressure, and biochemistry data at the beginning (index day) and 12 months after starting of the therapy. (Outcome time point: 12 months)

03

Conditions studied

  • Diabetic Nephropathy Type 2

Keywords

  • Diabetic Nephropathies
  • Extracorporeal low intensity shockwave therapy
  • Proteinuria
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age >18 y/o or \<80 y/o
  2. Diagnosed as type 2 diabetes.
  3. Baseline \<7.5%
  4. Baseline (eGFR) ≧15 and \<60 ml/min/1.73m2
  5. Baseline urine albumin-to-creatinine ratio (UACR) >30 and \<3000 mg/g
  6. Subject receives ACEi or ARB for 3 months before enrollment
  7. Subject is willing to sign the permit and receive 12 times shockwave therapy

Exclusion criteria

Exclusion Criteria:

  1. Subject is pregnant or breast feeding
  2. Subject has cancer or chronic inflammatory disease
  3. Subject has bleeding tendency, eg thrombocytopenia, PT > 2.5
  4. Subject has active urinary tract infection or other active infections
  5. Subject's sBP>160mmHg or dBP>100mmHg
  6. Subject has stroke, cardiac infection or arrhythmia in 6 months before enrollment
  7. Subject has local inflammation or infection over treatment areas
  8. Subject has pacemaker or other metal implants.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Sham comparator
    Control

    No intervention, no placebo, but do the same blood tests and examinations as experiment group at the same time points

    Other: Extracorporeal low-intensity shockwave

  • Experimental
    Extracorporeal low-intensity shockwave group

    with 12 times extracorporeal low intensity shockwave therapy and do the blood test and assessments at baseline, 3, 6, 12 m after initiation of therapy.

    Other: Extracorporeal low-intensity shockwave

Interventions

  • OtherExtracorporeal low-intensity shockwave

    Omnispec device to give a total of 1200 shockwaves, with low energy density at 0.1 mj/mm2 and a frequency of 120 shocks/min per kidney per treatment session, totally 12 times.

06

What researchers measure

Primary outcomes

  1. changes of estimated glomerular filtration rate

    using Modification of Diet in Renal Disease (MDRD) equation, which is eGFR (mL/min/1.73m2) = 175 × serum creatinine-1.154 × age-0.203× 0.742 (if female) to evaluate renal function

    Time frame: 12 month

  2. changes of proteinuria

    using spot urine albumin- and protein-creatinine ratio

    Time frame: 12 month

Secondary outcomes

  1. changes of systolic and diastolic blood pressure

    Let patients rest for 15 mins and check blood pressure using same sphygmomanometer.

    Time frame: 12 month

07

Study locations

1 of 1 sites recruiting
  • Kaohsiung Chang-Gung Memorial Hospital
    Kaohsiung, Please Select 833, Taiwan
    Recruiting
08

References and documents

Publications

  • 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. PubMed 33131308 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2017 (actual). Primary completion is estimated for Jun 2019, 23 months after the start.

Of 49 non-industry interventional studies with no phase under Diabetic Nephropathies, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 23 months is close to that.

Counting every sponsor, half of 50 studies reached it within 23 months; a quarter within 11 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2018
First posted
Feb 26, 2018
StartActual
Jul 1, 2017
Primary completionEst.
Jun 30, 2019
CompletionEst.
Jun 30, 2020
Last update
Feb 26, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03445247
Responsible party
Sponsor
First posted
Feb 26, 2018
Start date
Jul 1, 2017
Primary completion
Jun 30, 2019 (estimated)
Completion
Jun 30, 2020 (estimated)
Last update
Feb 26, 2018

Study contacts

Lung-Chih Li, MD, PhD.
Contact
longee01@gmail.com
886-7-7317123 ext. 8306

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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