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Evaluate Tolerability of Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations

Study to Evaluate Tolerability of Myfortic With Simulect Induction and Tacrolimus Without Steroids in Three Patient Populations; 1: Kidney/Pancreas Transplants,2: Diabetic Kidney Transplants, and 3: Non-diabetic Kidney Transplants

This study is designed to evaluate the tolerability of Myfortic®/Simulect® combination in diabetic patients in a steroid free regimen. Due to the diverse ethnicity of our transplant recipient population, the study will determine any different responses, including autoimmunity, between Hispanic, and Caucasian, patients.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

Myfortic® is an enteric-coated formulation of the sodium salt derivative of mycophenolic acid (MPA) that is administered to control kidney graft rejection. Myfortic® was developed to improve MPA-related upper gastrointestinal (GI) side effects by delaying the release of MPA until it reaches the large surface of the small bowel. Approximately half of all the kidney transplant recipients in the United States have diabetes mellitus. A recent analysis of approximately 30,000 kidney transplant recipients included in the U.S. Renal Data System showed that 42% of patients had pre-transplant diabetes (1). Moreover, 15% to 20% of patients develop diabetes after transplantation, a condition that is commonly known as post-diabetes mellitus (1-3). It was previously shown that the rate and extent of MPA absorption is minimally affected by diabetes (4). Limited data is available in the current literature on Myfortic® and Simulect® based therapy in diabetic patients.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Texas
      • Galveston, Texas, Forenede Stater, 77555
        • University of Texas Medical Branch

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:

  1. Adults (age 18 to 65 years of age), male or female Hispanic or Caucasian.
  2. Primary kidney or kidney transplant patients (cadaveric, living related, or living unrelated)
  3. Written inform consent obtained. The patients are willing to participate in the study at UTMB.
  4. Female with negative pregnancy test.
  5. PRA < 20 %.
  6. En-blocks and two kidneys (tx'd at the same time) will be allowed.
  7. Cold Ischemia time ≤ 30 hrs
  8. Hep C patients will be allowed to enroll in this study

Exclusion Criteria:

  1. Multi-organ transplants
  2. Transplant from non-heart beating donor (NHBD) or dual transplants
  3. A-B-O incompatible or positive cross match
  4. Conditions which significantly alter the absorption, distribution, and metabolism (except for diarrhea) of medications.
  5. Women of childbearing potential not using contraception method(s) as well as women who are breastfeeding
  6. Inability to tolerate oral medications
  7. Inability to sign a written consent form or to cooperate with investigators
  8. Use of an investigational medication in the past 30 days.
  9. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
  10. HIV positive patients
  11. History of psychosocial instability
  12. Mental incompetence

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Transplant recipients
All subjects receive identical drug treatment
Gastric emptying tests will be performed at baseline, 6 months and 12 months
Andre navne:
  • Gastric motility

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tolerability of Myfortic in combination with Simulect and Tacrolimus without steroids
Tidsramme: 24 months
Assure that immunosuppression protects graft function by decreased incidence of rejection and side effects
24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
GI complications
Tidsramme: 24 months
Gastric emptying test
24 months
Graft function
Tidsramme: 24 months

Renal function assessed by serum creatinine and calculating creatinine clearance.

Pancreas function assessed by glucose control, exogenous insulin requirement, HgbA1C

24 months
Biopsy proven rejection
Tidsramme: 24 months
Renal graft core biopsy will be performed on all suspected rejection.
24 months

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Luca Cicalese, MD, University of Texas

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. marts 2011

Primær færdiggørelse (Faktiske)

1. oktober 2012

Studieafslutning (Faktiske)

1. oktober 2012

Datoer for studieregistrering

Først indsendt

8. juni 2011

Først indsendt, der opfyldte QC-kriterier

30. juni 2011

Først opslået (Skøn)

4. juli 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. november 2020

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 10-244

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 .

Kliniske forsøg med Gastric emptying test

3
Abonner