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Belatacept to Prevent Organ Rejection in Kidney Transplant Patients (BESTT)

23. marts 2017 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

The Safety and Efficacy of Belatacept, Antithymocyte Globulin, and Sirolimus in Recipients of Non-HLA-identical Living-donor Renal Transplants (ITN023ST)

Belatacept is an experimental medication shown in clinical trials to have immune system suppression properties in people who have had renal (e.g., kidney) transplants. This study will determine whether a combination of anti-rejection drugs, including belatacept, can prevent the rejection of a first-time, non-human leukocyte antigen (HLA) identical renal transplant and allow patients to be safely withdrawn from anti-rejection therapy one year post-transplant.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

5

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94143
        • University of California, San Francisco
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University

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

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Belatacept
Immunosuppressive protocol consisting of belatacept, glucocorticoids, antithymocyte globulin (ATG), and sirolimus.
Medicin: Belatacept
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 navne:
  • Nulojix
  • LEA29Y
Medicin: Sirolimus
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 navne:
  • Rapamycin
  • Rapamune
Medicin: Anti-thymocyte globulin
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 navne:
  • ATG
  • Thymoglobulin®
  • anti-thymocyt immunoglobulin
Medicin: methylprednisolone
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 navne:
  • Medrol
  • glukokortikoid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute Rejection at 6-Months
Tidsramme: 6 months post-transplant

Cumulative incidence of acute rejection[1] at 6 months post-transplant based on local pathology biopsy reads

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
6 months post-transplant

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participant Survival at 12 Months Post-Transplant
Tidsramme: 12 months post-transplant
12 months post-transplant
Acute Rejection at 12-Months
Tidsramme: 12 months post-transplant

Incidence of acute rejection[1] at 12 months post-transplant

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
12 months post-transplant
Tolerance Induction
Tidsramme: 48 months
Time from transplantation to initiation of sirolimus withdrawal.
48 months
Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks
Tidsramme: 24 weeks post-transplant

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
Graft Survival at 12 Months Post-transplant
Tidsramme: 12 months post-transplant
12 months post-transplant
Time From Transplant to Acute Rejection
Tidsramme: Transplantation until rejection occurs (participants followed up to four years post-transplantation)

Time (days) from transplant to occurrence of acute rejection[1]

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Transplantation until rejection occurs (participants followed up to four years post-transplantation)
Proportion of Participants Requiring Antilymphocyte Therapy for Acute Rejection
Tidsramme: Participants followed from transplantation until completion of study (up to four years post-transplantation)

Proportion of participants who experienced acute rejection[1] requiring antilymphocyte therapy

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With Post-transplant Infections
Tidsramme: Participants followed from transplantation until completion of study (up to four years post-transplantation)
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)
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With Wound Complications
Tidsramme: Start of study to end of study
Start of study to end of study
Proportion of Participants With Malignancies
Tidsramme: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With a Sirolimus Associated Adverse Event
Tidsramme: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With Chronic Allograft Nephropathy
Tidsramme: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With Delayed Graft Function
Tidsramme: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With Post-transplant Diabetes Mellitus
Tidsramme: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbejdspartnere

Immune Tolerance Network (ITN)

Efterforskere

  • Ledende efterforsker: Flavio Vincenti, MD, University of California, San Francisco
  • Ledende efterforsker: Christian Larsen, MD, Emory University

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.

Generelle publikationer

Hjælpsomme links

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. december 2006

Primær færdiggørelse (Faktiske)

1. februar 2010

Studieafslutning (Faktiske)

1. februar 2010

Datoer for studieregistrering

Først indsendt

27. juni 2006

Først indsendt, der opfyldte QC-kriterier

27. juni 2006

Først opslået (Skøn)

29. juni 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. marts 2017

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DAIT ITN023ST

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Data access is provided to the public in Participant level data and additional relevant materials are available to the public in : 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools available to researchers; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal that makes data from the consortium's clinical trials publicly available.

Studiedata/dokumenter

  1. Individuelt deltagerdatasæt
    Informations-id: SDY674
    Oplysningskommentarer: ImmPort study identifier is SDY674
  2. Studieprotokol
    Informations-id: SDY674
    Oplysningskommentarer: ImmPort study identifier is SDY674. The study protocol is available in the Design tab section.
  3. Study summary, -design, -synopsis,- medications, -demographics, -lab tests, -files
    Informations-id: SDY674
    Oplysningskommentarer: ImmPort study identifier is SDY674
  4. Individuelt deltagerdatasæt
    Informations-id: ITN023ST
    Oplysningskommentarer: 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.
  5. Protocol synopsis, -data and reports, -specimens availability
    Informations-id: ITN023ST
    Oplysningskommentarer: 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.

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 .

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