Safety, Tolerability and Pharmacodynamics of AP214 Acetate in Patients Undergoing Cardiac Surgery
29. mai 2009 oppdatert av: Action Pharma A/S
The purpose of the present research study is to investigate for the first time, the safety and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary bypass graft and/or valve repair or replacement surgery.
AP214, the investigational drug, is being developed to potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.
Studieoversikt
Status
Avsluttet
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
75
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Florida
-
Gainesville, Florida, Forente stater, 32601
- Shands Hospital at Alachua General Hospital
-
Gainesville, Florida, Forente stater, 32610
- Shands Hopsital at University of Florida
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Has signed the trial specific informed consent form.
- Patients ≥ 18 years old, male or female, not of childbearing potential (postmenopausal or permanently sterilized e.g., tubal occlusion, hysterectomy, bilateral salpingectomy), regardless of ethnicity.
- Patients undergoing CABG, valve(s), CABG/valve and/or aortic root or ascending aortic aneurysm repair surgery.
- Cleveland Clinic Renal Score ≥ 2 (higher than average risk for AKI).
- EF ≥ 30%, evaluated within 2 months prior to screening visit.
Exclusion Criteria:
- Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
- Circulatory arrest in connection with aortic root or ascending aortic aneurysm repair surgery.
- Confirmed or suspected endocarditis.
- Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
- Receiving Aprotinin during the trial, from Screening to Day 90.
- Having undergone cardiovascular catheterization ≤ 48 hours prior to scheduled surgery.
- Active peptic ulcer disease and gastritis.
- Hemoccult positive stools, hematological, bleeding, and coagulation disorders.
- Receiving dopamine at renal doses (2-4 mcg/kg/min), from Screening to Day 90.
- S-Creatinine greater than 2.1 mg/dl.
- Known or suspected hypersensitivity to the investigational medicinal product.
- Known or suspected hypersensitivity to ondansetron or other selective 5-hydroxytryptamine 3 (5-HT3) receptor antagonists.
- Current participation in any other interventional clinical trial.
- Previously dosed with AP214.
- Use of investigational medicinal products within the previous 6 months.
- Body weight above 140 kg.
- History of any organ transplant.
- Women who are of childbearing potential, pregnant or breast-feeding.
- Current abuse of alcohol or substance, according to the investigator's medical judgment
- Has a mental incapacity or language barriers precluding adequate understanding of trial procedures.
- Is considered by the Investigator unsuitable to participate in the trial for any other reason for instance due to a significant serious underlying condition
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Three placebo bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).
|
|
Eksperimentell: AP214
|
Three AP214 bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To assess the safety and tolerability of AP214 administered as three 10-minute bolus infusions, in patients undergoing cardiac surgery that are at increased risk of AKI (descriptive analysis of AEs and SAEs from Day 0-14).
Tidsramme: From day 0-14
|
From day 0-14
|
|
To assess the impact of AP214 on cardiac surgery induced systemic inflammatory response syndrome determined by the post-operative peak plasma concentrations of IL-6 and IL-10 from 0-24 hours
Tidsramme: 0-24 hours
|
0-24 hours
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To assess the safety and tolerability of AP214 at an organ level as well as in terms of the overall mortality (heart, CNS, lung, wound, mortality)
Tidsramme: Day 0-90
|
Day 0-90
|
|
To assess the impact of AP214 on cardiac surgery induced systemic inflammatory response syndrome (post-operative peak plasma concentrations of TNF-α and IL-8 and AUC for TNF-α, IL-6, IL-8 and IL-10).
Tidsramme: 0-24 hours
|
0-24 hours
|
|
To assess the impact of AP214 for renal protection as measured by the development of post-surgical acute kidney injury (AKIN score)
Tidsramme: Day 0-14
|
Day 0-14
|
|
To assess the impact of AP214 on the development of post-surgical left ventricular dysfunction (determined by changes in left ventricular function from pre to post coronary bypass by transesophageal echocardiography
Tidsramme: 0-24 hours
|
0-24 hours
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Thomas M Beaver, MD, MPH, Division of Thoracic and Cardiovascular Surgery , University of Florida College of Medicine
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2008
Primær fullføring (Forventet)
1. juni 2009
Studiet fullført (Forventet)
1. juni 2009
Datoer for studieregistrering
Først innsendt
25. februar 2008
Først innsendt som oppfylte QC-kriteriene
25. februar 2008
Først lagt ut (Anslag)
5. mars 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. juni 2009
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. mai 2009
Sist bekreftet
1. mai 2009
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- AP214-CS004
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .