Study Investigating Rapamune For Post-Marketing Surveillance
21. november 2016 opdateret af: Pfizer
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune
To provide safety and effectiveness information for Rapamune during the post-marketing period as required by Korea Food and Drug Administration (KFDA) regulations in order to identify any potential drug related treatment factors in the Korean population, such as:
- Unknown adverse reactions, especially serious adverse reactions
- To assess the incidence of adverse reactions under the routine drug uses
- Factors that may affect the safety of the drug (e.g., proteinuria)
- Factors that may affect the effectiveness of the drug
Studieoversigt
Detaljeret beskrivelse
All patients who receive Rapamune for certain period of time should be included as far as patients consent to participate
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
209
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Daegu, Korea, Republikken, 705-717
- Yeungnam University Medical Center
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Gyeonggi-do, Korea, Republikken, 480-717
- The Catholic University of Korea Uijeongbu St. Mary's Hospital
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Pusan, Korea, Republikken, 600-730
- Maryknoll Medical Center
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Seoul, Korea, Republikken, 135-710
- Samsung Medical Center
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Seoul, Korea, Republikken, 138-736
- Asan Medical Center
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Seoul, Korea, Republikken, 143-729
- Konkuk University Medical Center
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Seoul, Korea, Republikken, 136-705
- Korea University Anam Hospital
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Seoul, Korea, Republikken, 134-814
- Kangdong Sacred Heart Hospital
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Seoul, Korea, Republikken, 137-701
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Korea, Republikken, 135-720
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, Korea, Republikken, 110-744
- Seoul National University Hospital (SNUH)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
13 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients who receive Rapamune after kidney transplantation
Beskrivelse
Inclusion Criteria:
- Subjects aged 13 years or older receiving renal transplants, who are newly administered Rapamune after a contract is made between Pfizer Korea and an investigator and/or an institution for conducting this study.
Exclusion Criteria:
- Any patient who does not agree that Pfizer and companies working with Pfizer use his/her information.
- Patients who have known hypersensitivity to Rapamune or its derivatives or any excipients in the formulation.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Rapamune
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Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs
Tidsramme: Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
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All AEs reported after the start of administration of Rapamune were considered as treatment-emergent AEs and summarized.
All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as AEs whose causal relationship to the study drug could not be excluded and classified as ADRs.
Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.
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Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
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Percentage of Participants With Clinically Significent Abnormal Laboratory Test
Tidsramme: Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
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Laboratory test was not mandatory because this study was a non-interventional study.
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Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies
Tidsramme: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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Renal biopsy was required to confirm the diagnosis of acute rejection.
However, due to the non-interventional nature of this study, biopsy could not be mandatory.
The decision of whether to perform a biopsy was made at the discretion of the investigator and the result was collected if performed.
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At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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Percentage of Participants Alive
Tidsramme: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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The investigator recorded the participant's survival status and evaluation date on the CRF.
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At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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Percentage of Participants With Survived Graft
Tidsramme: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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Graft survival was defined as not showing graft loss at the time of evaluation.
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At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula
Tidsramme: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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Graft function was evaluated by eGFR using Nankivell formula.
The investigator recorded the date of evaluation and the calculated value on the CRF.
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At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2011
Primær færdiggørelse (Faktiske)
1. juni 2015
Studieafslutning (Faktiske)
1. juni 2015
Datoer for studieregistrering
Først indsendt
7. juni 2007
Først indsendt, der opfyldte QC-kriterier
7. juni 2007
Først opslået (Skøn)
8. juni 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. januar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. november 2016
Sidst verificeret
1. november 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0468X1-4411
- B1741015 (Anden identifikator: Alias Study Number)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .