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End-stage Renal DiseasePhase 3CAPDNCT04344067

Far Infrared Therapy on Peritoneal Function of CAPD Patients

A Phase 3 study testing Far Infrared Therapy in people with End-stage Renal Disease, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

For patients with end-stage renal disease, peritoneal dialysis (PD) has been proven to be an alternative choice compared to hemodialysis as a type of maintenance renal replacement therapy. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
End-stage Renal Disease
What is being tested?
Far Infrared Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteTaiwan
Study dates
1 Jan 2016to 30 Jun 2020
Phase
Phase 3
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic peritoneal dialysis patients who have not received any FIR therapy within the previous 12 months
  • Patients on a standard continuous ambulatory peritoneal dialysis (CAPD) (1.5-2 L; 4-5 exchanges/day) or ambulatory peritoneal dialysis (APD) program

Who cannot join

  • History of CAPD-related peritonitis within 3 months prior to the study period;
  • History of cerebrovascular accident or myocardial infarction or interventional procedure (percutaneous transluminal coronary angioplasty or stent) for coronary artery disease within the 3 months prior to the study

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Chih-Ching Lin, MD, PhD, 02-2871-2121 ext. 2993, lincc2@vghtpe.gov.tw

    Chih-Ching Lin, MD, PhD

    Recruiting

Other trials in Taiwan

About this study

Official title: The Effect of Far Infrared Therapy on Peritoneal Function of CAPD Patients

For patients with end-stage renal disease, peritoneal dialysis (PD) has been proven to be an alternative choice compared to hemodialysis as a type of maintenance renal replacement therapy. Despite this, long-term PD is associated with structural membrane changes that are believed to contribute to alterations in solute transport and loss of ultrafiltration. Previous studies have proven that far-infrared (FIR) therapy may improve not only the arteriovenous fistula patency in hemodialysis patients but also abdominal discomfort due to encapsulating peritoneal sclerosis in PD patients. Since there is little information concerning this issue, this study was conducted in order to evaluate the possible effects of FIR therapy on the peritoneal function of patients receiving continuous ambulatory peritoneal dialysis (CAPD). The objective of this study is to evaluate the effect of FIR therapy on the peritoneal function, protein loss, and ultrafiltration capacity of CAPD patients.

Read the detailed description

A total of 100 CAPD patients will be enrolled in this study, including 50 in treatment group who will receive FIR therapy for 6 months and 50 in control group. Many parameters of blood and urine samples as well as ultrafiltration amount, dialysate urea nitrogen, creatinine, Na+, K+, total protein, CA-125, and glucose degradation product (GDP) for the dialysate effluent of not only the first and last exchanges but also the total exchanges of daily PD regimen will be measured for both groups at day 1 and 6th month. However, only the FIR group will receive tests of blood, urine and dialysate on day 2. The significance of the study is that patients might benefit from the prophylactic therapeutic effects of FIR therapy, leading to the reduction of the hospitalization costs and the need for interventional procedures in CAPD patient care in Taiwan.

Being tested
Far Infrared Therapy
Keywords
Peritoneal Dialysis, Far Infrared Therapy
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Far Infrared TherapyDevice

    The WSTM TY101 FIR emitter (WS Far Infrared Medical Technology Co., Ltd., Taipei, Taiwan) was used to conduct FIR therapy in this study. The electrified ceramic plates of the emitter generated electromagnetic waves with wavelengths in the range between 3 and 25 μm (a peak between 5 to 6 μm). The irradiating power density is 10 and 20 milliwatt (mw) /cm2 when the top radiator was set at a distance of 30 and 20 cm above the skin surface respectively.

Study groups in NCT04344067
Study groupRoleWhat they receive
Control GroupNo interventionNot described
Far Infrared Therapy GroupExperimentalIn this study, the top radiator of the far infrared emitter was set at a height of 25 cm above the umbilicus with a treatment time of 40 minutes during the initial 1 hour of both the first daily and the last night-time indwelling dialysate of each daily regular peritoneal dialysis regimen.
Receives: Device: Far Infrared Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. KT/V

    K - dialyzer urea clearance; t - dialysis time; V - total volume within the body that urea is distributed

    Measured: Change from baseline level at 6 months and 12 months

  2. Weekly creatinine clearance

    WCCr (L/wk/1.73m^2)

    Measured: Change from baseline level at 6 months and 12 months

Secondary outcomes (10)

  1. Ultrafiltration volume

    Peritoneal function parameter (mL)

    Measured: Change from baseline level at 6 months and 12 months

  2. Net volume

    Peritoneal function parameter (mL)

    Measured: Change from baseline level at 6 months and 12 months

  3. D/D0 glucose ratio

    Peritoneal function parameter

    Measured: Change from baseline level at 6 months and 12 months

  4. D/PCr ratio

    Peritoneal function parameter

    Measured: Change from baseline level at 6 months and 12 months

  5. D/P urea ratio

    Peritoneal function parameter

    Measured: Change from baseline level at 6 months and 12 months

  6. Albumin

    Biochemical function parameter (g/dL)

    Measured: Change from baseline level at 6 months and 12 months

  7. Blood urea nitrogen

    Biochemical function parameter (mg/dL)

    Measured: Change from baseline level at 6 months and 12 months

  8. Creatinine

    Biochemical function parameter (mg/dL)

    Measured: Change from baseline level at 6 months and 12 months

  9. Major cardiovascular adverse events

    3-point major adverse cardiovascular events (3P-MACE) comprising of non-fatal stroke, myocardial infarction, and cardiovascular death, coronary artery disease (CAD), hospitalized heart failure (HHF)

    Measured: Change from baseline level at 12 months

  10. Infection events (number of hospital admission events)

    Pneumonia, peritonitis

    Measured: Change from baseline level at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2020
  2. Study start1 Jan 2016
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion30 Jun 2020 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are assigned to either the control group or the treatment (far infrared therapy) group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04344067
Sponsor's protocol ID
2015-09-002B
Acronym
CAPD
Status last verified
Apr 2020
First submitted
19 Mar 2020
Last updated
22 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lin CC, Chang CF, Lai MY, Chen TW, Lee PC, Yang WC. Far-infrared therapy: a novel treatment to improve access blood flow and unassisted patency of arteriovenous fistula in hemodialysis patients. J Am Soc Nephrol. 2007 Mar;18(3):985-92. doi: 10.1681/ASN.2006050534. Epub 2007 Jan 31.

    PubMed 17267744

  • Lin CC, Liu XM, Peyton K, Wang H, Yang WC, Lin SJ, Durante W. Far infrared therapy inhibits vascular endothelial inflammation via the induction of heme oxygenase-1. Arterioscler Thromb Vasc Biol. 2008 Apr;28(4):739-45. doi: 10.1161/ATVBAHA.107.160085. Epub 2008 Jan 17.

    PubMed 18202320

  • Lin CC, Yang WC, Chen MC, Liu WS, Yang CY, Lee PC. Effect of far infrared therapy on arteriovenous fistula maturation: an open-label randomized controlled trial. Am J Kidney Dis. 2013 Aug;62(2):304-11. doi: 10.1053/j.ajkd.2013.01.015. Epub 2013 Mar 6.

    PubMed 23474008

  • Lin CC, Chung MY, Yang WC, Lin SJ, Lee PC. Length polymorphisms of heme oxygenase-1 determine the effect of far-infrared therapy on the function of arteriovenous fistula in hemodialysis patients: a novel physicogenomic study. Nephrol Dial Transplant. 2013 May;28(5):1284-93. doi: 10.1093/ndt/gfs608. Epub 2013 Jan 22.

    PubMed 23345623

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Far Infrared Therapy in people with End-stage Renal Disease, run by Taipei Veterans General Hospital, Taiwan 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 2 inclusion and 2 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 22 Apr 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

KT/V (time frame: Change from baseline level at 6 months and 12 months). 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 NCT04344067, which also lists 4 linked publications.

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 22 Apr 2020; AzTrials last refreshed its copy on 2 Nov 2026.

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