Diabetic Nephropathy Type 2NCT03445247
Extracorporeal Low-intensity Shockwave in Diabetic Nephropathy
A study testing Extracorporeal low-intensity shockwave in people with Diabetic Nephropathy Type 2, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Nephropathy Type 2
- What is being tested?
- Extracorporeal low-intensity shockwave
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, Please Select, 833
Lung-Chih Li, MD.PhD, 886-7317123 ext. 8306, longee01@gmail.com
About this study
Official title: An Investigation on the Effects of Extracorporeal Low-intensity Shockwave Therapy on Protenuria, Renal Function, and Blood Pressure in Type 2 Diabetic Patients in Stage 3-4 Chronic Kidney Disease
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)
- Conditions
- Diabetic Nephropathy Type 2
- Being tested
- Extracorporeal low-intensity shockwave
- Keywords
- Diabetic Nephropathies, Extracorporeal low intensity shockwave therapy, Proteinuria
- Medical subject headings
- Diabetic Nephropathies, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | No intervention, no placebo, but do the same blood tests and examinations as experiment group at the same time points Receives: 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. Receives: Other: Extracorporeal low-intensity shockwave |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 month
changes of proteinuria
using spot urine albumin- and protein-creatinine ratio
Measured: 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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Jul 2017
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Nephropathy Type 2Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445247
- Sponsor's protocol ID
- 104-7771A
- Status last verified
- Jul 2017
- First submitted
- 29 Jan 2018
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation on the Effects of Extracorporeal Low-intensity Shockwave Therapy on Protenuria, Renal Function, and Blood Pressure in Type 2 Diabetic Patients in Stage 3-4 Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03445247
- Acronym / sponsor ID
- 104-7771A
- Conditions
- Diabetic Nephropathy Type 2
- Keywords
- Diabetic Nephropathies, Extracorporeal low intensity shockwave therapy, Proteinuria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: Extracorporeal low-intensity shockwaveNo intervention, no placebo, but do the same blood tests and examinations as experiment group at the same time points |
| Extracorporeal low-intensity shockwave group | Experimental | Other: Extracorporeal low-intensity shockwavewith 12 times extracorporeal low intensity shockwave therapy and do the blood test and assessments at baseline, 3, 6, 12 m after initiation of therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal low-intensity shockwaveOmnispec 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. | Other | Control, Extracorporeal low-intensity shockwave group |
Primary outcome
changes of estimated glomerular filtration rate
Time frame: 12 month
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
changes of proteinuria
Time frame: 12 month
using spot urine albumin- and protein-creatinine ratio
1 secondary outcome
changes of systolic and diastolic blood pressure
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Derived from this study: PubMed 33131308Klomjit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal low-intensity shockwave in people with Diabetic Nephropathy Type 2, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lung-Chih Li, MD, PhD. (886-7-7317123 ext. 8306, longee01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of estimated glomerular filtration rate (time frame: 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03445247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.