Safety and Effect of Low-Energy Extracorporeal Shockwave Therapy (ESWT) on the Renal Allograft in Transplant Recipients.

NCT ID: NCT03602807

Last Updated: 2018-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-26

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim is to investigate the safety and potential effect of Low-energy Shockwave Therapy (ESWT) on the transplanted kidney. The treatment consist of ESWT two times a week for three weeks, six treatments in total.

The hypothesis is that ESWT with improve the renal function, by reducing proteinuria (in a 24-hour urine collection test) and improving renal clearance of 51Cr-EDTA.

The safety of ESWT on the renal allograft will be assessed during and after treatments.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Transplant Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active treatment

Group Type EXPERIMENTAL

Extracorporeal Shockwave Therapy

Intervention Type DEVICE

2 treatments a week for 3 weeks consisting of 3000 focused shockwaves of 4Hz and 0,20mJ/mm2 applied over the kidney allograft.

Treatment is performed using the STORZ DUOLITH® SD1 T-TOP "F-SW ultra"

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Extracorporeal Shockwave Therapy

2 treatments a week for 3 weeks consisting of 3000 focused shockwaves of 4Hz and 0,20mJ/mm2 applied over the kidney allograft.

Treatment is performed using the STORZ DUOLITH® SD1 T-TOP "F-SW ultra"

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Minimum 1 year ago since last kidney transplant
* P-Creatinin under 300, in the last 3 blood-samples
* U-Albumine/creatinine ratio over 100, in the last 3 urine-samples

Exclusion Criteria

* Not Danish speaking.
* Obstructive uropathy
* Suspected autoimmune disease in the kidney graft
* Symptomatic urinal tract infection (UTI)
* Severe psychiatric disorder
* Pregnant or planning on becoming pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ronja Niemann Lundrup

Undergraduate researcher, BSc.med

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Odense University Hospital

Odense, Region Syddanmark, Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ronja N Lundrup, BSc.med

Role: CONTACT

+45 40 76 40 05

Lars Lund, Professor, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ronja N Lundrup, BSc.med

Role: primary

+45 40 76 40 05

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33131308 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ESWT-tx

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Use of Predigraft in Kidney Transplant Patients
NCT04969757 ACTIVE_NOT_RECRUITING NA
Kidney Transplant Volumetry
NCT03855085 COMPLETED
Preserve-Transplant Study
NCT03102996 COMPLETED PHASE4
Elastographic Imaging of Renal Transplants
NCT00935727 TERMINATED PHASE1