Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Tacrolimus/Everolimus vs. Tacrolimus/MMF hos pædiatriske hjertetransplantationsmodtagere ved hjælp af MATE-score (TEAMMATE)

7. juli 2026 opdateret af: Kevin Daly, Boston Children's Hospital

Fase III multicenter åbent randomiseret klinisk forsøg, der sammenligner Everolimus og lavdosis tacrolimus med tacrolimus og mycophenolatmofetil 6 måneder efter transplantation for at forhindre langsigtede komplikationer efter pædiatrisk hjertetransplantation

TEAMMATE-forsøget vil inkludere 210 pædiatriske hjertetransplantationspatienter fra 25 centre 6 måneder efter transplantationen og følge hver patient i 2,5 år. Halvdelen af ​​deltagerne vil modtage everolimus og lavdosis tacrolimus, og den anden halvdel vil modtage tacrolimus og mycophenolatmofetil. Forsøget vil afgøre, hvilken behandling der er bedre til at reducere den kumulative risiko for koronararterievaskulopati, kronisk nyresygdom og biopsi bevist akut cellulær afstødning uden en stigning i grafttab på grund af alle årsager (f. infektion, PTLD, antistofmedieret afstødning).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Median overlevelse efter pædiatrisk hjertetransplantation (HT) er 15 år i den nuværende æra. Dette betyder, at en betydelig del af patienter, der er transplanteret i barndommen, ikke overlever til voksenalderen eller kræver hjertetransplantation på grund af komplikationer relateret til hjertetransplantation. Disse komplikationer omfatter hjertetransplantationsafstødning, infektion, koronararteriesygdom, post-transplantation lymfoproliferativ lidelse (PTLD; en form for lymfom set hos transplantationsmodtagere) og nyresvigt. De fleste komplikationer stammer ikke fra selve hjertetransplantationen, men fra de lægemidler, der almindeligvis anvendes til at undertrykke immunsystemet for at forhindre afstødning. I USA er tacrolimus (TAC) og mycophenolatmofetil (MMF) dukket op i løbet af det seneste årti som standarden for behandling af pædiatrisk hjertetransplantationsimmunsuppression. Mens pædiatrisk overlevelse er forbedret betydeligt i æraen med TAC og MMF, er post-HT-komplikationer fortsat et stort problem, der begrænser medianoverlevelsen til 15 år. For nylig er everolimus (EVL) dukket op som et potentielt alternativt immunsuppressivt middel, der kan forhindre afstødning, koronararteriesygdom og nyresvigt mere effektivt end TAC/MMF, når det administreres i kombination med lavdosis tacrolimus (LDTAC). Foreløbige undersøgelser tyder på, at EVL og dets førstegenerationsanalog sirolimus tolereres godt hos børn efter HT, uanset om det startes som reaktion på koronararteriesygdom, som reaktion på kronisk nyresygdom eller empirisk 4-6 måneder efter transplantation i et forsøg på at forhindre udviklingen af ​​disse komplikationer1. Undersøgelser er dog generelt begrænset til enkeltcenter-oplevelser ved hjælp af historiske kontroller og har utilstrækkelig statistisk kraft til at påvise behandlingsforskelle. Dette vil være det første randomiserede kliniske multicenterforsøg med vedligeholdelsesimmunsuppression ved pædiatrisk hjertetransplantation for systematisk at evaluere sikkerheden og effektiviteten af ​​EVL med LDTAC vs. TAC/MMF for at forhindre langsigtede komplikationer, der fører til død/tab af transplantat. Score for større uønskede transplantationshændelser (MATE) vil tjene som det primære endepunkt til at drive forsøget. Fordi der i øjeblikket ikke findes nogen Food & Drug Administration (FDA)-godkendte immunsuppressiva til børn efter hjertetransplantation (alle recepter er off-label), og markedsincitamenterne til at støtte et forsøg er begrænsede, har efterforskerne finansieret forsøget gennem et regnskabsår 2016 peer reviewed Medical Research Program Clinical Trial Award sponsoreret af Department of Defense-kontoret for de kongresstyrede medicinske forskningsprogrammer. Det er værd at bemærke, at i modsætning til voksne har børn en væsentlig længere potentiel forventet levetid, hvis post-transplantationskomplikationer kan minimeres, hvilket gør forebyggelse af sene komplikationer til en presserende prioritet for det pædiatriske hjertetransplantationsmiljø.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

211

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Children's of Alabama
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85016
        • Phoenix Children's Hospital
    • California
      • Loma Linda, California, Forenede Stater, 92354
        • Loma Linda University
      • Los Angeles, California, Forenede Stater, 90027
        • Children's Hospital Los Angeles
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA Mattel Children's Hospital
      • Palo Alto, California, Forenede Stater, 94304
        • Stanford University
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Children's Hospital Colorado
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20010
        • Children's National Medical Center
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610-0297
        • University of Florida Congenital Heart Center
      • Hollywood, Florida, Forenede Stater, 33021
        • Joe DiMaggio Children's Hospital
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Children's Healthcare of Atlanta Emory
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Lurie Children's Hospital
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Boston Children's Hospital
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Medical Center
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Washington University in St. Louis School of Medicine
    • New York
      • New York, New York, Forenede Stater, 10032
        • Children's Hospital of New York
      • The Bronx, New York, Forenede Stater, 10803
        • Children's Hospital at Montefiore
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45229
        • Cincinnati Children's Hospital Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • The Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • Children's Hospital of Pittsburgh of University of Pittsburgh School of Medicine
    • Texas
      • Dallas, Texas, Forenede Stater, 75235
        • Children's Health Dallas University of Texas Southwestern
      • Houston, Texas, Forenede Stater, 77027
        • Texas Children's Hospital
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • Primary Children's Hospital
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Seattle Children's Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Children's Hospital of Wisconsin

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

Ikke ældre end 21 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Ortotopisk hjertetransplantation
  2. Alder < 21 år på tidspunktet for transplantation
  3. Stabil immunsuppression på tidspunktet for randomisering uden kontraindikation for everolimus, tacrolimus eller mycophenolatmofetil
  4. Planlagt opfølgning på et studiested i undersøgelsens 30 måneders varighed.
  5. Emnet eller juridisk voksenrepræsentant, der er i stand til at give informeret samtykke (generelt vil der blive anmodet om samtykke for børn i alderen 12 år eller ældre).

Ekskluderingskriterier:

  1. Multiorgantransplantation (f. hjerte-lunge eller hjerte-lever).
  2. Kendt overfølsomhed over for everolimus, sirolimus, tacrolimus eller mycophenolatmofetil (MMF) eller over for komponenter i lægemidlet.
  3. Patienter i vedligeholdelsesbehandling med kortikosteroider, der overstiger en dosisækvivalent af prednison 0,1 mg/kg/dag ved randomisering.
  4. Høj risiko for afstødning defineret som aktiv afstødning, tilbagevendende (≥ 2 episoder med grad 2R afstødning) cellulær afstødning, tilbagevendende afstødning (≥ 2 episoder af enhver grad) med hæmodynamisk kompromittering, steroid-resistent afstødning eller uafklaret antistof-medieret afstødning under den første 6 måneder efter hjertetransplantation
  5. Graftdysfunktion (LVEF <40 % eller kiletryk >22 mmHg eller hjerteindeks <2,2 L/min/m2)
  6. Stadie 4 eller 5 CKD (eGFR <30 ml/min/1,73 m2)
  7. Moderat eller svær proteinuri
  8. Aktiv infektion, der kræver hospitalsindlæggelse eller behandlingsdosis medicinsk terapi.
  9. Patienter med igangværende sårhelingsproblemer, klinisk signifikant sårinfektion, der kræver fortsat terapi eller anden alvorlig kirurgisk komplikation efter vurderingen af ​​stedets hovedforsker.
  10. Fastende serumkolesterol ≥300 mg/dL ELLER større end eller lig med 7,75 mmol/L, OG fastende triglycerider ≥2,5x den øvre grænse for normal (ULN). Bemærk: I tilfælde af at en eller begge af disse tærskler overskrides, kan patienten kun inkluderes efter initiering af passende lipidsænkende medicin, og reduktion af serumkolesterol- og triglyceridniveauer til under eksklusionsintervaller er bekræftet.
  11. Ukontrolleret diabetes mellitus.
  12. Diagnose af post-transplantation lymfoproliferativ lidelse (PTLD) i løbet af de første 6 måneder efter hjertetransplantation.
  13. Anamnese med manglende overholdelse af medicinske regimer.
  14. Patienter, der behandles med lægemidler, der er stærke inducere eller hæmmere af cytokrom P450 3A4 (CYP3A4), og som ikke kan afbryde behandlingen
  15. Patienter, der er gravide eller ammer eller har til hensigt at blive gravide i løbet af undersøgelsesperioden.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Everolimus/Lavdosis Tacrolimus

Everolimus ca. 0,6 mg/m2/dosis indtaget gennem munden hver 12. time i 30 måneder. Everolimus dosis vil blive justeret for at opnå en bundkoncentration på 3-8 ng/ml.

Tacrolimus 0,0125 mg/kg/dosis gennem munden hver 12. time i 30 måneder. (Tacrolimus dosis vil blive justeret for at opnå en laveste koncentration på 3-5 ng/ml, indtil forsøgspersonerne er 1 år efter hjertetransplantation. Efter 1 år post-hjertetransplantation vil tacrolimus dosis blive justeret for at opnå en bundkoncentration på 2,5-4,5 ng/ml.)
Medicin: Everolimus
Everolimus tablet
Andre navne:
  • Zorttress
Medicin: Tacrolimus
Tacrolimus kapsel eller flydende suspension
Andre navne:
  • Prograf
Aktiv komparator: Tacrolimus/Mycophenolatmofetil

Tacrolimus 0,05 mg/kg/dosis gennem munden hver 12. time i 30 måneder. (Tacrolimus dosis vil blive justeret for at opnå en laveste koncentration på 7-10 ng/ml, indtil forsøgspersonerne er 1 år efter hjertetransplantation. Efter 1 år post-hjertetransplantation vil tacrolimus dosis blive justeret for at opnå en bundkoncentration på 5-8 ng/ml.)

Mycophenolatmofetil 600 mg/m2/dosis gennem munden hver 12. time i 30 måneder.
Medicin: Tacrolimus
Tacrolimus kapsel eller flydende suspension
Andre navne:
  • Prograf
Medicin: Mycophenolatmofetil
Mycophenolat Mofetil kapsel eller flydende suspension
Andre navne:
  • Cellcept

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
EFFICACY: MATE-3 Score
Tidsramme: 30 months post-randomization
MATE-3 is a validated score ranging from 0 to 12. The score adds together each subscore so that it represents the cumulative burden of three major adverse transplant events: Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). Complete details of the score can be found in the study protocol. A higher score represents a worse outcome.
30 months post-randomization
SAFETY: MATE-6 Score
Tidsramme: 30 months post-randomization
MATE-6 is a validated score ranging from 0 to 24. The score adds together each subscore so that it represents the cumulative burden of all six major adverse transplant events: Coronary Artery Vasculopathy (CAV), Chronic Kidney Disease (CKD), Biopsy-proven Acute Cellular Rejection (ACR), pathologic diagnosis of Antibody-Mediated Rejection (AMR), Infection, and Post-Transplant Lymphoproliferative Disorder (PTLD). Complete details of the score can be found in the study protocol. A higher score represents a worse outcome.
30 months post-randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Efficacy: Overall Patient Survival
Tidsramme: Up to 30 months post-randomization
Number of participants who experienced death from any cause
Up to 30 months post-randomization
Efficacy: Overall Allograft Survival
Tidsramme: Up to 30 months post-randomization
Number of participants who experienced death or heart re-transplantation
Up to 30 months post-randomization
Efficacy: Change in Kidney Function
Tidsramme: 0 to 6 months, 0 to 12 months, 0 to 30 months post-randomization
Change in estimated glomerular filtration rate (eGFR) using the modified Schwartz equation. A positive number indicates improved kidney function, a negative number indicates worsened kidney function.
0 to 6 months, 0 to 12 months, 0 to 30 months post-randomization
Efficacy: Freedom From CKD Event
Tidsramme: From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a chronic kidney disease MATE. A chronic kidney disease MATE was defined as an eGFR < 60 ml/min/1.73 m^2 during follow-up or worsening by at least one MATE score if < 60 ml/min/1.73 m^2 at baseline. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Efficacy: Freedom From CAV Event
Tidsramme: From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) cardiac allograft vasculopathy (CAV) during follow up as graded by the angiography core laboratory. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Efficacy: Freedom From BP-ACR Event
Tidsramme: From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) biopsy-proven Acute Cellular Rejection (ACR) MATE event during follow-up. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Efficacy: Freedom From Composite Failure
Tidsramme: From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) the composite of death, graft loss, 2R/3R acute cellular rejection or rejection with hemodynamic compromise. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Efficacy: EuroQOL EQ-5D Y (Youth Version)
Tidsramme: 30 months post-randomization
The EuroQOL EQ-5D Y uses a visual-analog scale and asks the participant to mark an X on the line to show how good or bad your is health TODAY. The scale ranges from 0 to 100.
30 months post-randomization
Safety: Freedom From AMR
Tidsramme: From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a pathologic diagnosis of Antibody-Mediated Rejection (AMR) MATE Event. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From Infection
Tidsramme: From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a serious infection MATE during follow-up. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From PTLD
Tidsramme: From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a Post-Transplant Lymphoproliferative Disorder (PTLD) MATE event during follow-up. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Number of Participants Experiencing Adverse Events
Tidsramme: From enrollment to 30 months after enrollment
Adverse events reported throughout the study. Adverse events are classified by CTCAE classification. Serious adverse events include CTCAE classes 3, 4, and 5.
From enrollment to 30 months after enrollment
Safety: Freedom From Major Transplant Events (Composite)
Tidsramme: From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) any MATE event, this includes chronic kidney disease, cardiac allograft vasculopathy, acute cellular rejection, antibody mediated rejection, serious infection, and post-transplant lymphoproliferative disease. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity CKD Event
Tidsramme: From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a chronic kidney disease MATE of Grade 2 or greater (eGFR <45 ml/min/1.73 m^2 or on dialysis) or death due to chronic kidney disease. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity CAV Event
Tidsramme: From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a cardiac allograft vasculopathy MATE of Grade 2 or greater. Grade 2 or greater is the same as having International Society of Heart and Lung Transplantation cardiac allograft vasculopathy Grade 2 or 3 or death due to cardiac allograft vasculopathy. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity ACR Event
Tidsramme: From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) an acute cellular rejection MATE of Grade 2 or greater. Grade 2 or greater is the equivalent of treated rejection with an assigned International Society of Heart & Lung Transplantation acute cellular rejection grade 2 or grade 3 or rejection with hemodynamic compromise (decreased ejection fraction, need for IV medicine to support heart, need for mechanical circulatory support) or death due to acute cellular rejection. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity AMR Event
Tidsramme: From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) an antibody mediated rejection MATE of Grade 2 or greater. Grade 2 or greater is the equivalent of treated rejection with an assigned International Society of Heart & Lung Transplantation antibody mediated rejection grade 2 or grade 3 or antibody mediated rejection with hemodynamic compromise (decreased ejection fraction, need for IV medicine to support heart, need for mechanical circulatory support) or death due to antibody mediated rejection. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity Infection Event
Tidsramme: From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a serious infection MATE of Grade 2 or greater. Grade 2 infections require treatment with intravenous antibiotics or antivirals for 5 or more days. Grade 3 includes treatment of sepsis, endocarditis, invasive infection, or infection leading to respiratory failure. Grade 4 is death due to infection. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity PTLD Event
Tidsramme: From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a post-transplant lymphoproliferative disease MATE of Grade 2 or greater. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Efficacy: Freedom From Composite of CAV, CKD, BP-ACR, or Any CMV Infection
Tidsramme: From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) at least one of cardiac allograft vasculopathy, chronic kidney disease with estimated glomerular filtration rate less than or equal to 60 ml/min/1.73m2, treated acute cellular rejection, or any cytomegalovirus infection. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Efficacy: Change in CKD Stage
Tidsramme: Baseline visit through 30 months post-randomization
Change in chronic kidney disease stage where improvements in CKD stage can take on a negative value.
Baseline visit through 30 months post-randomization
Efficacy: MATE-3 Score Where CKD Score is Calculated by Change From Baseline Visit
Tidsramme: Baseline visit through 30 months post-randomization
MATE-3 is a validated score ranging from 0 to 12. The score adds together each subscore so that it represents the cumulative burden of three major adverse transplant events: Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). For this version of the score, the chronic kidney disease score is replaced by the change in MATE-CKD score from baseline visit through 30 months post-randomization. CKD change score can assume a negative value. This modified score can range from -2 to 12. A higher score represents a worse outcome.
Baseline visit through 30 months post-randomization
Efficacy: MATE-3 Score Where CKD Score is Replaced by Change in CKD Stage
Tidsramme: Baseline visit through 30 months post-randomization
MATE-3 is a validated score ranging from 0 to 12. The score adds together each subscore so that it represents the cumulative burden of three major adverse transplant events: Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). For this version of the score, the chronic kidney disease score is replaced by the change in chronic kidney disease stage from the baseline visit through 30 months post-randomization. Chronic kidney disease stage change score can assume a negative value. This modified score can range from -2 to 12. A higher score represents a worse outcome.
Baseline visit through 30 months post-randomization
Efficacy: Composite Score Consisting of MATE CAV, MATE BP-ACR, MATE CKD Score, and Any CMV Infection.
Tidsramme: Baseline visit through 30 months post-randomization
Composite score ranging from 0 to 16. The score adds each subscore to represent the cumulative burden of three major adverse transplant events plus CMV infection. The three major adverse transplant events are Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). Any CMV infection is assigned a score of 1 with additional points using the MATE infection scoring criteria. Full details of the score can be found in the protocol. A higher score represents a worse outcome.
Baseline visit through 30 months post-randomization
Efficacy: Composite Score Consisting of MATE CAV, MATE BP-ACR, Change in CKD Stage, and Any CMV Infection.
Tidsramme: Baseline visit through 30 months post-randomization
Composite score ranging from -2 to 16. The score adds each subscore to represent the cumulative burden of Cardiac Allograft Vasculopathy (CAV), chronic kidney disease, and Biopsy-proven Acute Cellular Rejection (ACR). Any CMV infection is assigned a score of 1 with additional points using the MATE infection scoring criteria. The chronic kidney disease MATE score is replaced by change in CKD stage. A higher score represents a worse outcome.
Baseline visit through 30 months post-randomization
Efficacy: Lansky Scores
Tidsramme: Baseline
Validated functional performance score, assigned by clinician assessment: Lansky score is assigned if < 16 years old at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Baseline
Efficacy: Lansky Scores
Tidsramme: 18 months post-randomization
Validated functional performance score, assigned by clinician assessment: Lansky score is assigned if < 16 years old at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
18 months post-randomization
Efficacy: Lansky Scores
Tidsramme: 30 months post-randomization
Validated functional performance score, assigned by clinician assessment: Lansky score is assigned if < 16 years old at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
30 months post-randomization
Efficacy: Karnofsky Scores
Tidsramme: Baseline
Validated functional performance score, assigned by clinician assessment: Karnofsky score is assigned if >=16 years at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Baseline
Efficacy: Karnofsky Scores
Tidsramme: 18 months post-randomization
Validated functional performance score, assigned by clinician assessment: Karnofsky score is assigned if >=16 years at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
18 months post-randomization
Efficacy: Karnofsky Scores
Tidsramme: 30 months post-randomization
Validated functional performance score, assigned by clinician assessment: Karnofsky score is assigned if >=16 years at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
30 months post-randomization

Samarbejdspartnere og efterforskere

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

Sponsor

Boston Children's Hospital

Samarbejdspartnere

United States Department of Defense
Stanford University

Efterforskere

  • Studiestol: Christopher S Almond, MD, MPH, Stanford University
  • Studiestol: Kevin P Daly, MD, Boston Children's Hospital
  • Ledende efterforsker: Lynn A Sleeper, ScD, Boston Children's Hospital

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

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 (Faktiske)

29. januar 2018

Primær færdiggørelse (Faktiske)

17. april 2023

Studieafslutning (Faktiske)

17. maj 2023

Datoer for studieregistrering

Først indsendt

18. december 2017

Først indsendt, der opfyldte QC-kriterier

21. december 2017

Først opslået (Faktiske)

29. december 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P00025970
  • PR160574 (Andet bevillings-/finansieringsnummer: U.S. Department of Defense)
  • IND 127980 (Anden identifikator: Food and Drug Administration)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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