- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01656135
Reference Group Trial for The ONE Study
Reference Group Trial for The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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London, Det Forenede Kongerige, SE1 9RT
- Guy's Hospital in affiliation with King's College London
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Oxford, Det Forenede Kongerige, OX3 7LE
- Churchill Hospital in affiliation with the University of Oxford
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California
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San Francisco, California, Forenede Stater, 94143
- University of California San Francisco
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Nantes, Frankrig, 44093
- CHU de Nantes hotel-Dieu
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Milan, Italien, 20132
- Ospedale San Raffaele
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Berlin, Tyskland, 13353
- Charite Campus Virchow-Klinikum
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Regensburg, Tyskland, 93053
- University Hospital Regensburg
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Organ Donor:
A prospective donor is eligible for the research if all of the following inclusion criteria apply:
- Eligible for live kidney donation
- Aged at least 18 years
- An ABO blood type compatible with the organ recipient
- Willing and able to provide a blood sample for The ONE Study Subprojects
- Willing to provide personal and medical/biological data for the trial
- Signed and dated written informed consent.
In signing the donor information sheet/informed consent form (DIS/ICF), organ donors agree to provide a blood sample for the IM Subproject, and permit access to their medical records for the collection of specified demographic and medical/biological data for the trial.
Organ Recipient:
- Chronic renal insufficiency necessitating kidney transplantation and approved to receive a primary kidney allograft from a living donor
- Aged at least 18 years
- Able to commence the immunosuppressive regimen at the protocol-specified time point
- Willing and able to participate in The ONE Study subprojects
- Signed and dated written informed consent.
Exclusion Criteria:
Organ Donor:
If a prospective donor fulfils any of the following criteria, then they are ineligible for the trial:
- Genetically identical to the prospective organ recipient at the HLA loci
- Exposure to any investigational agents at the time of kidney donation, or within 28 days prior to kidney donation
- Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel
- Subjects unable to freely give their informed consent (e.g. individuals under legal guardianship).
Organ Recipient:
- Patient has previously received, or is scheduled to receive, any tissue or organ transplant other than the planned kidney graft
- Known sensitivity to tacrolimus, mycophenolate, or corticosteroids
- Genetically identical to the prospective organ donor at the HLA loci
- PRA grade > 40% within 6 months prior to enrolment
- Previous treatment with any desensitisation procedure (with or without IVIg)
- Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully-treated non-metastatic basal/squamous cell carcinoma of the skin)
- Evidence of significant local or systemic infection
- HIV-positive, EBV-negative or suffering chronic viral hepatitis
- Significant liver disease, defined as persistently elevated AST and/or ALT levels >2 x ULN (Upper Limit of Normal range)
- Malignant or pre-malignant haematological conditions
- Any uncontrolled medical condition or concurrent disease that could interfere with the study objectives
- Any condition which, in the judgement of the Investigator, would place the subject at undue risk
- Ongoing treatment with systemic immunosuppressive drugs at study entry
- Participation in another clinical trial during the study or within 28 days prior to planned study entry
- Female patients of child-bearing potential with a positive pregnancy test at enrolment
- Female patients who are breast-feeding
All female patients of child-bearing potential UNLESS:
- The patient is willing to maintain a highly effective method of birth control for the duration of the study
- The career, lifestyle, or sexual orientation of the patient ensures that there is no risk of pregnancy for the duration of the study (at the discretion of the local Investigator)
- Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule
- Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel
- Patients unable to freely give their informed consent (e.g. individuals under legal guardianship).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Andet: Reference Group
Basiliximab (Simulect®):
Prednisolone:
Steroid tapering should not proceed if graft rejection has occurred or if renal dysfunction is observed. Mycophenolate Mofetil (MMF, or biologic equivalent): Treatment with MMF should commence one day prior to transplantation (on Day -1) and should continue indefinitely, with a dose reduction after two weeks:
Tacrolimus (or biologic equivalent):
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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biopsi-bekræftet forekomst af akut afstødning
Tidsramme: 60 uger
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60 uger
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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forekomst af patienter behandlet for subklinisk akut afstødning
Tidsramme: 60 uger
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60 uger
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time to first acute rejection episode
Tidsramme: within 60 weeks
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within 60 weeks
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severity of acute rejection episodes
Tidsramme: within 60 weeks
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within 60 weeks
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total immunosuppressive burden
Tidsramme: 60 weeks
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60 weeks
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incidence of chronic graft dysfunction
Tidsramme: 60 weeks
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60 weeks
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incidence of graft loss through rejection
Tidsramme: 60 weeks
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60 weeks
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incidence of adverse drug reactions
Tidsramme: 60 weeks
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60 weeks
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incidence of major infections
Tidsramme: 60 weeks
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60 weeks
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incidence of neoplasia
Tidsramme: 60 weeks
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60 weeks
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Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Immune Monitoring (IM) assessment
Tidsramme: 60 weeks
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60 weeks
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Health Economics (HEC) assessment
Tidsramme: 60 weeks
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60 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Edward K. Geissler, Ph.D., University of Regensburg
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ONErgt11
- 260687 (Andet bevillings-/finansieringsnummer: EU FP7 Programme)
- 2011-004301-24 (EudraCT nummer)
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