Tidlige signaler for overgangen fra immunstillstand til aktivering i leverallograft-mikromiljøet og i sirkulasjonen (iSYNAPSE)
Tidlige signaler på overgangen fra immunhvil til aktivering i levertransplantatmikromiljøet og i sirkulasjonen (RTB-018)
This is a prospective multi-center, longitudinal study to determine efficacy of 50 percent Immunosuppression (IS) reduction. One hundred fully eligible participants will reduce IS by 50 percent in two steps. Liver tests will be checked every 0.5 months through month 4, once a month through month 12, and every other month through month 18. Liver transplant (LTx) center visits will take place at screening, months 6, 12 and 18 after initiating IS dose reduction. A protocol driven liver biopsy to adjudicate the endpoint will be performed at 18 months. The duration of the study from time of starting IS dose reduction to the primary endpoint assessment is 18 months.
The primary objective is to assess the efficacy of 50 percent IS dose reduction in children with Liver transplants (LTxs)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Ada Chao
- Telefonnummer: 415-353-7004
- E-post: ada.chao@ucsf.edu
Studiesteder
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California
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San Francisco, California, Forente stater, 94143
- Rekruttering
- UCSF Benioff Children's Hospital
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Ta kontakt med:
- Emily Stekol Moore
- E-post: emily.stekol@ucsf.edu
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Har ikke rekruttert ennå
- Children's Hospital Colorado
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Ta kontakt med:
- Michelle Landis
- E-post: Michelle.landis@childrenscolorado.org
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20007
- Rekruttering
- MedStar Georgetown University Hospital
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Ta kontakt med:
- Iryna Asipenka
- E-post: Iryna.M.Asipenka@medstar.net
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Georgia
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Atlanta, Georgia, Forente stater, 30307
- Har ikke rekruttert ennå
- Emory University School of Medicine/Children's Healthcare of Atlanta
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Ta kontakt med:
- Jordyn Turner
- Telefonnummer: 404-785-3690
- E-post: Jordyn.turner@choa.org
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Rekruttering
- Ann and Robert H. Lurie Children's Hospital of Chicago
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Ta kontakt med:
- Catherine Chapin
- Telefonnummer: 312-227-5511
- E-post: cchapin@luriechildrens.org
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New York
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New York, New York, Forente stater, 10029
- Rekruttering
- Icahn School of Medicine at Mount Sinai
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Ta kontakt med:
- Puja Patel
- Telefonnummer: 212-659-8039
- E-post: puja.patel4@mountsinai.org
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New York, New York, Forente stater, 10032
- Rekruttering
- Columbia University Medical Center
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Ta kontakt med:
- Ava Whalen
- E-post: w3876@cumc.columbia.edu
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Ohio
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Cincinnati, Ohio, Forente stater, 45229
- Rekruttering
- Cincinnati Children's Hospital Medical Center
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Ta kontakt med:
- Jennifer Hawkins
- Telefonnummer: 513-636-7818
- E-post: jennifer.hawkins@cchmc.org
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 15224
- Har ikke rekruttert ennå
- Children's Hospital of Philadelphia
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Ta kontakt med:
- Bryanna Domenick
- Telefonnummer: 267-425-1078
- E-post: DOMENICKB@CHOP.edu
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Pittsburgh, Pennsylvania, Forente stater, 15213
- Rekruttering
- University of Pittsburgh Medical Center
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Ta kontakt med:
- Daniel Pieratt
- E-post: pierattdw@upmc.edu
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Tennessee
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Nashville, Tennessee, Forente stater, 37232
- Har ikke rekruttert ennå
- Monroe Carell Jr. Children's Hospital at Vanderbilt
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Ta kontakt med:
- Carly Bhave
- E-post: carly.bhave@vumc.org
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Participant and parent or guardian must be able to understand and provide informed assent and consent, respectively
- Recipient of a living or deceased donor Liver transplant (LTx) at <7 years of age
- > 3 years but <7 years after LTx at the time of study enrollment
- Stable liver tests defined as baseline serum alanine aminotransferase (ALT) level < 30 IU/l and gamma-glutamyl transferase (GGT) level < 50 IU/l (based on the average of the 3 most recent values prior to screening; all must be within 1 year of screening; 2 must be within 6 months of screening)
- No Acute rejection (AR) or chronic rejection within 12 months of enrollment
- Tacrolimus monotherapy for > 6 months with baseline 12-hour trough levels <8 ng/mL (based on the average of 3 values prior to screening; all must be within 1 year of screening; 2 must be within 6 months of screening)
- Participants of childbearing potential must have a negative pregnancy test upon study entry
Exclusion Criteria:
- Liver transplant (LTx) for autoimmune disease, including autoimmune hepatitis or primary sclerosing cholangitis
- LTx for hepatitis B or hepatitis C
- Recipient of any other organ transplant or liver re-transplant, except for patients who have a repeat LTx within 30 days of first LTx who are eligible for enrollment
- >=50 percent dose increase in tacrolimus within 12 months of enrollment
- Discontinued a second Immunosuppression (IS) agent within 12 months of enrollment
- Systemic illness requiring chronic or recurrent use of IS for which there is a risk of reactivation if tacrolimus is reduced
- Use of medication to treat systemic conditions which in the judgement of the investigator could influence results of the study
- Active or chronic infection requiring treatment
- Inability or unwillingness to comply with the study protocol
- Use of investigational drug within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of enrollment
- Has any condition that, in the opinion of the investigator, will interfere with safe participation in the trial
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: IS dose reduction
Eligible participants will reduce immunosuppression (IS) by 50 percent in two steps. For subjects taking tacrolimus once daily:
For subjects taking tacrolimus twice daily:
For participants taking different doses of tacrolimus in the morning and evening, the clinical site will confer will the protocol chair and PI to determine the schedule for IS reduction |
Prospective multi-center, longitudinal study to determine the success rate of 50% immunosuppression (IS) dose reduction. One hundred fully eligible participants will reduce IS by 50% in two steps |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Achieving successful 50 percent Immunosuppression (IS) reduction
Tidsramme: At 18 months
|
Defined as meeting both biochemical and histological criteria of stability |
At 18 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Acute Rejection (AR) Episodes Within Each Banff Severity Category
Tidsramme: At 18 months
|
The proportion of acute rejection (AR) episodes within each observed Banff severity category will be measured. |
At 18 months
|
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The proportion of participants who experience Acute rejection (AR)
Tidsramme: At 18 months
|
Defined as either biopsy-proven or clinical AR |
At 18 months
|
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Achieving clinically successful 50 percent Immunosuppression (IS) reduction
Tidsramme: At 18 months
|
Defined as meeting biochemical but not histological criteria of stability |
At 18 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Sandy Feng, MD, Ph.D., University of California San Francisco School of Medicine: Transplantation
- Studiestol: John Bucuvalas, M.D., Icahn School of Medicine at Mount Sinai: Transplantation
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- DAIT RTB-018
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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