NCT03445247

Brief 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.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration 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, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

February 26, 2018

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

January 29, 2018

Last Update Submit

February 22, 2018

Conditions

Diabetic Nephropathy Type 2

Keywords

Diabetic NephropathiesExtracorporeal low intensity shockwave therapyProteinuria

Outcome Measures

Primary Outcomes (2)

  • 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

    12 month

  • changes of proteinuria

    using spot urine albumin- and protein-creatinine ratio

    12 month

Secondary Outcomes (1)

  • changes of systolic and diastolic blood pressure

    12 month

Study Arms (2)

Control

SHAM COMPARATOR

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

Extracorporeal low-intensity shockwave group

EXPERIMENTAL

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

Extracorporeal low-intensity shockwaveOTHER

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.

ControlExtracorporeal low-intensity shockwave group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 y/o or \<80 y/o
  • Diagnosed as type 2 diabetes.
  • Baseline HbA1C \<7.5%
  • Baseline glomerular filtration rate (eGFR) ≧15 and \<60 ml/min/1.73m2
  • Baseline urine albumin-to-creatinine ratio (UACR) \>30 and \<3000 mg/g
  • Subject receives ACEi or ARB for 3 months before enrollment
  • Subject is willing to sign the permit and receive 12 times shockwave therapy

You may not qualify if:

  • Subject is pregnant or breast feeding
  • Subject has cancer or chronic inflammatory disease
  • Subject has bleeding tendency, eg thrombocytopenia, PT INR \> 2.5
  • Subject has active urinary tract infection or other active infections
  • Subject's sBP\>160mmHg or dBP\>100mmHg
  • Subject has stroke, cardiac infection or arrhythmia in 6 months before enrollment
  • Subject has local inflammation or infection over treatment areas
  • Subject has pacemaker or other metal implants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang-Gung Memorial Hospital

Kaohsiung City, Please Select, 833, Taiwan

RECRUITING

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

Conditions

Diabetic NephropathiesProteinuria

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Lung-Chih Li, MD, PhD.

CONTACT

886-7-7317123longee01@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 26, 2018

Study Start

July 1, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2020

Last Updated

February 26, 2018

Record last verified: 2017-07

Locations

TW(1)