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Open-Label tvåarmad studie för att bedöma säkerhet och tid för CRBSI hos försökspersoner från födseln till < 18 års ålder

22 september 2026 uppdaterad av: CorMedix Therapeutics

En öppen studie med två armar (DefenCath® vs. Institutional Standard of Care) för att bedöma säkerhet och tid till kateterrelaterade blodomloppsinfektioner (CRBSI) hos patienter från födsel till yngre än 18 år med njursvikt som får hemodialys en central venkateter

This study is a post-marketing approval requirement to assess the safety and time to Catheter-related Bloodstream Infections (CRBSI) of DefenCath in pediatric population (birth to less than 18 years of age) who are on chronic HD for kidney failure.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

36

Fas

  • Fas 4

Utökad åtkomst

Inte längre tillgänglig utanför den kliniska prövningen. Se utökad åtkomstpost.

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35233
        • Rekrytering
        • Children's of Alabama/University of Alabama
        • Kontakt:
        • Kontakt:
    • Arizona
      • Phoenix, Arizona, Förenta staterna, 85016
    • California
      • Palo Alto, California, Förenta staterna, 94304
    • Delaware
      • Wilmington, Delaware, Förenta staterna, 19803
    • New Jersey
      • Hackensack, New Jersey, Förenta staterna, 07601
    • Texas

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Inte äldre än 17 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • All participants must be < 18 years of age and must meet the following inclusion criteria:
  • The investigator, or a person designated by the investigator, will obtain written informed consent from each study participant's legal guardian and the participant's assent, when applicable, before any study-specific activity is performed. All legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand.
  • A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow up; accompany the participant to the study site on each assessment day according to the schedule of activities (SoA) (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant during the scheduled study visits; accurately and reliably dispense study intervention as directed.
  • The participant has kidney failure and undergoes chronic hemodialysis (HD) at least 2 times per week.
  • The participant has an HD central venous catheter (CVC) and is placed in a jugular or subclavian vein.
  • The participant has demonstrated the ability to achieve an appropriate minimum blood flow (Qb) for the participant's relative age and weight for at least 2 consecutive dialysis sessions to enable successful HD.
  • The participant is likely to require the use of a CVC for at least 60 days, based on clinical assessment.
  • The participant is willing to comply with specified follow-up evaluations and prescribed dialysis therapy.
  • The participant is not expected to expire within 180 days, based on clinical assessment.
  • Female participants of childbearing potential:
  • Must agree to abide by contraception requirements, must not be lactating, and avoid pregnancy during study participation from the first Screening visit until 30 days after the last administration of study treatment.
  • Must commit to an additional method of birth control in addition to male partners agreeing to use condoms with spermicide, throughout the study including for at least 30 days after the last administration of study treatment:
  • True abstinence: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable).

Combined (containing estrogen and progestogen) hormonal birth control (oral, intravaginal, injectable, or transdermal) associated with inhibition of ovulation initiated at least 30 days before dose administration.

  • Progestogen only hormonal birth control (oral, injectable, or implantable) associated with inhibition of ovulation initiated at least 30 days before study dose administration.
  • Bilateral tubal occlusion/ligation.
  • Intrauterine device.
  • Intrauterine hormone releasing system.
  • Vasectomized partner.
  • NOTE: If the childbearing potential changes after start of the study (e.g., a premenarchal female participant experiences menarche) or the risk of pregnancy changes (e.g., a female participant who is not heterosexually active becomes active), the participant must discuss this with the investigator, who should determine if a female participant must begin a highly effective method of contraception, or a male participant must use a condom. If reproductive status is questionable, additional evaluation should be considered.
  • Male participants who are sexually active with a female partner of childbearing potential must agree to use male condoms and spermicide, even if the male participant has undergone a successful vasectomy (males with vasectomy can use condoms without spermicide), from Day 1 until at least 30 days after the last administration of study treatment.

Exclusion Criteria:

  • Any participant who is currently receiving systemic antibiotics. Topical antibiotic use is permitted.
  • Visible evidence of compromised skin integrity is present at the catheter exit site or evidence of a catheter exit site infection.
  • The participant has received any thrombolytic treatment (i.e., tissue plasminogen activator [tPA] - Cathflo®), not as part of the institution's standard of care for patency management, in their current catheter within 30 days of randomization.
  • The fill volume of catheter lumen(s) is unknown or cannot be determined.
  • The participant uses any type of antimicrobial-coated or heparin-coated catheter.
  • Documented chronic bleeding diathesis, active or recurrent bleeding within 30 days prior to randomization.
  • Documented history of an atrial thrombus or known hypercoagulable state.
  • The participant has open, non-healing skin ulcers.
  • Any participant who has received an allogeneic hematopoietic stem cell transplant within the last year.
  • The participant has current requirement for systemic chemotherapy and/or immunosuppression and absolute neutrophil count <500 cells/µL that occurred in the past 4 weeks.
  • An active malignancy that either in and of itself or by virtue of its treatment with chemotherapy or biologic therapy results in neutropenia, leukopenia and/or immunosuppression.
  • Known allergy or absolute contraindication to taurolidine, citrate, or heparin, or a history of heparin induced thrombocytopenia (HIT).
  • Unstable malignancy.
  • Cirrhosis with encephalopathy.
  • The participant is currently taking another medication with known systemic drug interaction with taurolidine, citrate, or heparin.
  • The participant is anticipated to receive a renal transplant within 90 days (participants can be on the transplant list, but a participant with a known or anticipated transplant date within the next 90 days should be excluded).
  • The participant has a clinically significant cardiac rhythm or functional disorder.
  • The participant has severe hypoxemia, respiratory acidosis, asphyxia, or hypotension prior to randomization based on assessment of the investigator.
  • Any other medical condition which renders the participant unable to or unlikely to complete the study, or which would interfere with optimal participation in the study or produce significant risk to the participant.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Kontrollera
Läkemedel: Standard of Care

Site specific standard of care
Experimentell: DefenCath®
Läkemedel: (taurolidine and heparin) catheter lock solution

for central venous catheter instillation use

Andra namn:
  • DefenCath®

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to first clinical diagnosis of Catheter-related Bloodstream Infections (CRBSI)
Tidsram: Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

To demonstrate the effectiveness of DefenCath as a catheter lock solution (CLS) for prevention of CRBSI in pediatric participants receiving chronic hemodialysis (HD) through a central venous catheter (CVC) for the treatment of kidney failure.
Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)
Descriptive analysis characterizing the relative rates of deaths, AEs, and SAEs
Tidsram: Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

To demonstrate safety of DefenCath as a CLS in pediatric participants receiving chronic HD through a CVC for the treatment of kidney failure
Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to catheter removal due to CRBSI
Tidsram: Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

To evaluate the catheter removal due to CRBSI in pediatric participants who are receiving chronic HD through a CVC for kidney failure.
Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

CorMedix Therapeutics

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

8 juli 2025

Primärt slutförande (Beräknad)

1 juli 2028

Avslutad studie (Beräknad)

1 april 2029

Studieregistreringsdatum

Först inskickad

2 december 2024

Först inskickad som uppfyllde QC-kriterierna

2 december 2024

Första postat (Faktisk)

4 december 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PEDI-LOCK

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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