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Immunosuppressant Medication Dosed Daily After Kidney Transplant

30 listopada 2020 zaktualizowane przez: University of Colorado, Denver

Kidney Immunosuppression Dosed Daily Only (KIDDO) - A Pilot Study

Medication non-adherence is a major risk factor for graft dysfunction and graft loss among pediatric and adult transplant recipients. Rates of non-adherence in these populations are estimated between 30 and 70%, with the highest prevalence in adolescent and young adult (AYA) transplant recipients. Treatment-related factors known to impact rates of adherence include the number of medication doses per day and the number of tablets or capsules a patient takes per day, or "pill burden". One approach to minimizing dosing frequency and pill-burden includes transitioning patients to once-daily formulations. The current literature investigating utilization of once-daily immunosuppressive regimens in the AYA kidney transplant population is limited.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

One approach to minimizing dosing frequency and pill-burden includes transitioning patients to once-daily formulations.3 The current literature investigating utilization of once-daily immunosuppressive regimens in the AYA kidney transplant population is limited. Two studies have demonstrated safe and effective conversion of twice-daily tacrolimus to the Astagraf® in stable pediatric solid organ transplant recipients.4,5 Patients maintained equivalent tacrolimus exposure and experienced similar rates of rejection and graft loss in the first year post-conversion.5 To date, experience with another once-daily extended release (XR) tacrolimus product, Envarsus XR®, has not been published in the AYA population. Additionally, adherence studies evaluating a once-daily immunosuppression regimen including extended-release tacrolimus and azathioprine (which is dosed once daily as opposed to the twice daily dosing required for azathioprine's alternative mycophenolate mofetil) have not been conducted.

Of note, and even though twice-daily mycophenolate has been shown to be superior to once-daily azathioprine early post-transplant, more long-term data suggest that this advantage may not persist.6 Furthermore, a recent Cochrane review addressed the question of mycophenolate versus azathioprine as primary anti-proliferative immunosuppression for kidney transplant recipients; it concluded that "balancing the benefits and harms of the two drugs remains a major task of the transplant physician to decide which agent" is appropriate for the individual patient. 7 Moreover, once-daily immunosuppression with tacrolimus extended-release and once-daily azathioprine has been used with excellent results at a British center that focusses on AYA kidney transplant recipients.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

1

Faza

  • Wczesna faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80045
        • Children's Hospital Colorado

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

13 lat do 22 lata (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  1. Age 13-22 years
  2. Tanner stage 4/5
  3. "Stable" kidney transplant status, as determined by the primary transplant team
  4. At minimum 1 year post-kidney transplant or patients meeting all of the above inclusion criteria except 4) who have instead been transitioned to azathioprine by the primary transplant team due to intolerability of mycophenolate mofetil secondary to adverse medication effects (i.e. neutropenia, gastrointestinal intolerance etc.)

Exclusion Criteria:

  1. < Tanner stage 4
  2. Kidney transplant performed at an institution other than Children's Hospital Colorado, Lurie Children's Hospital of Chicago, or Cincinnati Children's Hospital
  3. Recipients of dual solid organ transplants (i.e. heart kidney, liver kidney).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Adolescent and Young Adult (AYA) Kidney Transplant Recipients
AYA kidney transplant recipients will receive a Medication Event Monitoring System (MEMS) in the form of a medication bottle and cap system and once daily tacrolimus XR 1-10mg
Inny: Medication Event Monitoring System (MEMS)
AYA kidney recipients will receive a Medication Event Monitoring System (MEMS) via medication bottle and cap system
Lek: Once-Daily Tacrolimus extended release
AYA kidney recipients will receive once daily tacrolimus XR 1-10mg daily
Inne nazwy:
  • Envarus XR

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Health-Related Quality of Life: as assessed by change in PedsQL
Ramy czasowe: Day 0, Day 60, Day 210
Pediatric Quality of Life (PedsQL) Transplant Module Version 3.0 will be used to assess quality of life prior to and after transition from twice to once daily immunosuppressant medication regimen. Health-related quality of life (HRQOL) has been defined as an individual's subjective experience of their illness, and the impact that illness and its treatment have on the individual's functioning in a variety of domains. The PedsQL is a 46-item self- and parent-report measure that rates HRQOL in 8 domains (medication adherence, medication side-effects, social relationship, physical discomfort, worries regarding health status, treatment anxiety, impact on appearance, and communication). The PedsQL Transplant Module assesses physical functioning, emotional functioning, social functioning, and school functioning and was developed through focus groups, cognitive interviews, pretesting, and field testing measurement development protocols. Higher scores indicate lower problems.
Day 0, Day 60, Day 210
Adherence to medical therapies and medications: as assessed by Medication Event Monitoring System (MEMS) at Day 30
Ramy czasowe: Day 30
MEMS data will be accessed prior to transition to once-daily medications (baseline adherence) and analyzed accordingly. Dates and times in which medication bottles were opened will be recorded.
Day 30
Adherence to medical therapies and medications: as assessed by Medication Event Monitoring System (MEMS) at Day 60
Ramy czasowe: Day 60
MEMS data will be accessed the first month of transition to once-daily medications (intervention adherence) and analyzed accordingly. Dates and times in which medication bottles were opened will be recorded.
Day 60
Adherence to medical therapies and medications: as assessed by Medication Event Monitoring System (MEMS) at Day 210
Ramy czasowe: Day 210
MEMS data will be accessed 6 months after transition to once-daily medications (retention adherence) and analyzed accordingly. Dates and times in which medication bottles were opened will be recorded.
Day 210
Adherence to medical therapies and medications: as assessed by Change in Tacrolimus Trough Concentration Variance
Ramy czasowe: Day 0, Day 30, Day 60, and Day 240

Tacrolimus trough goals between 4-7ng/mL as per Transplant Immunosuppression Protocols. Student T-test, repeated measures for parametric data).

The standard deviation of tacrolimus troughs will be calculated from the 4 tacrolimus trough values obtained for clinical care purposes preceding Study Visit 1 (SD1). The standard deviation of tacrolimus troughs will be calculated again from the 4 tacrolimus trough values obtained for clinical care purposes preceding Study Visit 4 (SD2).
Day 0, Day 30, Day 60, and Day 240
Adherence to medical therapies and medications:as assessed by Change in Adolescent Medication Barriers Scale (AMBS)
Ramy czasowe: Day 0, Day 60, Day 210
17 item scale that corresponds to the Parent Medication Barriers Scale (PMBS) with 16 items. Both have strong internal consistency and are scored on a 5-point Likert scale from Strongly Disagree to Strongly Agree. A total score can be calculated, and there are subdomains of disease frustration/adolescent issues, regimen adaptation/cognitive issues, and ingestion issues, with an additional parent reminder domain on the PMBS. Lower scores indicate less barriers to medication adherence.
Day 0, Day 60, Day 210
Adherence to medical therapies and medications: as assessed by Change in The Medical Adherence Measure (MAM)
Ramy czasowe: Day 0, Day 60, Day 210
Semi-structured interview that has four general modules to assess adherence with medication, diet, exercise, and clinic attendance, as well as illness-specific modules. For the purpose of this study, the Medication and Clinic Attendance Modules will be completed. Non-adherence scores can be calculated based on the degree of adherence on a spectrum of 0%-100% adherent to capture the fluctuations and intricacies of occasional or slightly inconsistent adherence. Missed adherence score = number of doses missed out of the doses prescribed × 100%. Late adherence score = number of doses taken late out of the doses prescribed × 100%, where late is defined as greater than one hour later than the usual routine. Adherence is assessed for each medication separately and then averaged across medications.
Day 0, Day 60, Day 210

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Long-term measures of graft and patient survival: as assessed by change in serum creatinine and urinary protein
Ramy czasowe: Day 0, Day 30, Day 60, Day 210, and Day 240
Markers of graft function will be assessed by measuring levels of serum creatinine and urinary protein. Lower serum creatinine and urinary protein indicate better long-term graft and patient survival.
Day 0, Day 30, Day 60, Day 210, and Day 240
Long-term measures of graft and patient survival: as assessed by change in markers of proteinuria
Ramy czasowe: Day 30 and Day 210
Markers of proteinuria will be assessed by urinalysis and random urinary protein/creatinine ratio. Lower urinary protein/creatinine ratio indicates better long-term measures of graft and patient survival.
Day 30 and Day 210
Long-term measures of graft and patient survival: as assessed by number of episodes of rejection
Ramy czasowe: Up to Day 240
Graft rejection episodes will be determined to have occurred if indicated by transplant biopsy results. Occurrences of graft rejection episodes among participants will be assessed up to Day 240.
Up to Day 240
Long-term measures of graft and patient survival: as assessed by change in presence of donor-specific antibody monitoring
Ramy czasowe: Day 0 and Day 240
Presence of donor-specific antibodies (DSA) prior to and after initiation of intervention.
Day 0 and Day 240
Long-term measures of graft and patient survival: as assessed by change in presence of BK virus screening results
Ramy czasowe: Day 0 and Day 240
Includes assessing the viral load to monitor presence of BK virus.
Day 0 and Day 240

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Colorado, Denver

Śledczy

  • Główny śledczy: Jens Goebel, MD, Children's Hospital Colorado
  • Główny śledczy: Mary Chandran, MD, Children's Hospital Colorado

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 listopada 2019

Zakończenie podstawowe (Rzeczywisty)

27 listopada 2020

Ukończenie studiów (Rzeczywisty)

27 listopada 2020

Daty rejestracji na studia

Pierwszy przesłany

1 listopada 2019

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 listopada 2019

Pierwszy wysłany (Rzeczywisty)

7 listopada 2019

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 grudnia 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 listopada 2020

Ostatnia weryfikacja

1 listopada 2020

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 17-2311

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Nie

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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