- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00346151
Belatacept to Prevent Organ Rejection in Kidney Transplant Patients (BESTT)
The Safety and Efficacy of Belatacept, Antithymocyte Globulin, and Sirolimus in Recipients of Non-HLA-identical Living-donor Renal Transplants (ITN023ST)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Drugs that suppress the immune system have contributed to increased success of transplantation; however, to prevent organ rejection, transplant recipients need to take immunosuppressive drugs for the rest of their lives. These drugs make patients more susceptible to infection and certain kinds of cancer. Belatacept is an experimental medication that specifically targets immune reactions against transplanted organs and has been shown to be effective in preventing kidney transplant rejection in previous clinical trials. Both thymoglobulin, an antibody, and sirolimus, an anti-rejection drug, prevent rejection by lowering the response of the immune system to the transplanted organ. This study will evaluate whether belatacept, along with thymoglobulin and sirolimus, is safe in kidney transplant patients. The study will also evaluate this regimen's potential to allow tapering and eventual discontinuation of all immunosuppressive drugs.
This study will last up to 4 years. At the time of transplant, participants will begin an immunosuppressive treatment regimen consisting of thymoglobulin, sirolimus, and belatacept. Participants will receive infusions of thymoglobulin on days 1 through 4, and a combination of oral sirolimus (daily) and belatacept infusions at day 5, then weeks 2, 4, 8, and monthly for at least 2 years. Dose reduction of belatacept will occur at 12 weeks post-transplant. At Year 2, eligible participants may choose to begin drug withdrawal or continue study therapy through the end of the study. Study visits will occur weekly for the first two months, then monthly. These visits will include belatacept treatment, general medical assessments, blood and urine collection, and other assessments to determine overall health of the recipient's immune system and kidney transplant and to better understand the way the immune system works in the acceptance or rejection of organ transplants.
*** IMPORTANT NOTICE: *** The National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network do not recommend the discontinuation of immunosuppressive therapy for recipients of cell, organ, or tissue transplants outside of physician-directed, controlled clinical studies. Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances, upon the recommendation and with the guidance of your health care provider.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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California
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San Francisco, California, Forente stater, 94143
- University of California, San Francisco
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Emory University
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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:
- Receiving first renal (e.g., kidney) transplant
- Transplant is from a non-HLA-identical living donor
- Willing to use acceptable forms of contraception
Exclusion Criteria:
- Positive for anti-human globulin (AHG) or T-cell cross-match with the donor
- Receiving multiple-organ transplant
- History of cancer within the 5 years prior to study entry. Patients who have certain nonmelanoma skin cancers are not excluded
- Human immunodeficiency virus (HIV) infected
- Hepatitis B (HBV) or C (HCV) virus infected
- Other active infections
- Active tuberculosis (TB) infection within the 3 years prior to study entry
- Pregnancy or breastfeeding
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 |
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Eksperimentell: Belatacept
Immunosuppressive protocol consisting of belatacept, glucocorticoids, antithymocyte globulin (ATG), and sirolimus.
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10 mg/kg given intravenously (IV) on transplant (day 1), day 5, and at weeks 2, 4, 8 and 12, then 5 mg/kg IV every 4 weeks
Andre navn:
4 mg/day (oral tablet) at transplant (day 1), then dose adjusted to maintain serum trough level of 8-12 ng/mL for at least 1 year
Andre navn:
1.5 mg/kg given IV daily on days 1 through 4. Subjects are premedicated with glucocorticoids, acetaminophen 650 mg by mouth, and diphenhydramine 25- 50 mg by mouth prior to each dose.
Andre navn:
500 mg given IV at transplant (day 1), then given 250 mg IV on day 2 and given 0.5 mg/kg IV or prednisone 0.5 mg/kg given by mouth on days 3 and 4
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Acute Rejection at 6-Months
Tidsramme: 6 months post-transplant
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Cumulative incidence of acute rejection[1] at 6 months post-transplant based on local pathology biopsy reads
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6 months post-transplant
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Participant Survival at 12 Months Post-Transplant
Tidsramme: 12 months post-transplant
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12 months post-transplant
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Acute Rejection at 12-Months
Tidsramme: 12 months post-transplant
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Incidence of acute rejection[1] at 12 months post-transplant
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12 months post-transplant
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Tolerance Induction
Tidsramme: 48 months
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Time from transplantation to initiation of sirolimus withdrawal.
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48 months
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Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks
Tidsramme: 24 weeks post-transplant
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GFR utilizing clearance of iothalamate. GFR is an index of level of kidney function. A higher value means better kidney function. |
24 weeks post-transplant
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Graft Survival at 12 Months Post-transplant
Tidsramme: 12 months post-transplant
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12 months post-transplant
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Time From Transplant to Acute Rejection
Tidsramme: Transplantation until rejection occurs (participants followed up to four years post-transplantation)
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Time (days) from transplant to occurrence of acute rejection[1]
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Transplantation until rejection occurs (participants followed up to four years post-transplantation)
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Proportion of Participants Requiring Antilymphocyte Therapy for Acute Rejection
Tidsramme: Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of participants who experienced acute rejection[1] requiring antilymphocyte therapy
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Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of Participants With Post-transplant Infections
Tidsramme: Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of participants who experienced infections post-transplant.
Participants were checked for any type of opportunistic infection at all study visits post-transplantation (up to 4 years post-transplantation)
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Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of Participants With Wound Complications
Tidsramme: Start of study to end of study
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Start of study to end of study
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Proportion of Participants With Malignancies
Tidsramme: Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of Participants With a Sirolimus Associated Adverse Event
Tidsramme: Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of Participants With Chronic Allograft Nephropathy
Tidsramme: Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of Participants With Delayed Graft Function
Tidsramme: Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of Participants With Post-transplant Diabetes Mellitus
Tidsramme: Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Flavio Vincenti, MD, University of California, San Francisco
- Hovedetterforsker: Christian Larsen, MD, Emory University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
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
Ytterligere relevante MeSH-vilkår
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antiemetika
- Gastrointestinale midler
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Nevrobeskyttende midler
- Beskyttende agenter
- Antibakterielle midler
- Antibiotika, antineoplastisk
- Antifungale midler
- Immune Checkpoint-hemmere
- Metylprednisolon
- Immunoglobuliner
- Sirolimus
- Abatacept
- Thymoglobulin
- Antilymfocyttserum
- Glukokortikoider
Andre studie-ID-numre
- DAIT ITN023ST
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Studiedata/dokumenter
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Datasett for individuell deltaker
Informasjonsidentifikator: SDY674Informasjonskommentarer: ImmPort study identifier is SDY674
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Studieprotokoll
Informasjonsidentifikator: SDY674Informasjonskommentarer: ImmPort study identifier is SDY674. The study protocol is available in the Design tab section.
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Study summary, -design, -synopsis,- medications, -demographics, -lab tests, -files
Informasjonsidentifikator: SDY674Informasjonskommentarer: ImmPort study identifier is SDY674
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Datasett for individuell deltaker
Informasjonsidentifikator: ITN023STInformasjonskommentarer: TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available.
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Protocol synopsis, -data and reports, -specimens availability
Informasjonsidentifikator: ITN023STInformasjonskommentarer: TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available.
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. .
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University of OxfordUkjentPancreas Transplant AvvisningStorbritannia
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Universitaire Ziekenhuizen KU LeuvenFullførtForekomst av utvidet renal clearance | Risikofaktorer for økt renal clearanceBelgia
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Andrew B AdamsBristol-Myers SquibbFullført
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Oregon Health and Science UniversityFullført
Kliniske studier på Belatacept
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Bristol-Myers SquibbFullført
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Guizhou Provincial People's HospitalAktiv, ikke rekrutterende
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Methodist Health SystemAktiv, ikke rekrutterendeBruk av Belatacept hos nyretransplanterte pasienterForente stater
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Bristol-Myers SquibbFullførtNyretransplantasjonForente stater, Argentina, Tyskland, Italia, Chile, Spania, Brasil, Sverige, Belgia, Frankrike, Ungarn, Australia, Sør-Afrika, Østerrike, Canada, Storbritannia, Polen, Tsjekkia, Norge
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Ain Shams UniversityRekruttering
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Bristol-Myers SquibbFullførtFriske FrivilligeForente stater
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Bristol-Myers SquibbFullførtLeddgiktForente stater, Nederland, Belgia, Canada, Tyskland, Frankrike, Irland, Sveits, Storbritannia
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University of MarylandBristol-Myers SquibbFullførtSluttstadium nyresykdomForente stater
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East Carolina UniversityFullført