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Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients

20 lutego 2018 zaktualizowane przez: Pfizer

A Phase 2, Multicenter, Open-label, Active Comparator-controlled, Extension Trial To Evaluate The Long-term Safety And Efficacy Of Cp-690,550 In Renal Allograft Recipients

This is a study that will follow transplant patients from Study A3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in Portugal where the study will follow transplant patients through Month 36 posttransplant. Patients will continue their study medications that were previously assigned.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

178

Faza

  • Faza 2

Kontakty i lokalizacje

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

Lokalizacje studiów

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital, Department of Renal Medicine
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Central Northern Adelaide Renal and Transplantation Service
      • Woodville, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Belgia
      • Leuven, Belgia, 3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
    • Brussels
      • Anderlecht, Brussels, Belgia, 1070
        • Hopital Erasme
  • Brazylia
      • Sao Paulo, Brazylia, 04038-002
        • Hospital Do Rim E Hipertensão
    • RS
      • Porto Alegre, RS, Brazylia, 90020-090
        • Irmandade Santa Casa de Misericordia de Porto Alegre
    • SP
      • Sao Paulo, SP, Brazylia, 04038-002
        • Hospital Do Rim E Hipertensão
      • Sao Paulo, SP, Brazylia, 04039-033
        • Ambulatorio Pos Transplante do Hospital do Rim a Hipertensao
  • Czechy
      • Praha 4 Krc, Czechy, 140 21
        • Institut klinické a experimentální medicíny
  • Francja
      • Paris Cedex 15, Francja, 75743
        • Hopital Necker
      • Vandoeuvre Les Nancy, Francja, 54500
        • CHRU de Nancy-Brabois - Service de Nephrologie
  • Hiszpania
      • Barcelona, Hiszpania, 08036
        • Hospital Clínic i Provincial de Barcelona
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Hiszpania, 08907
        • Hospital Universitari de Bellvitge
  • Holandia
      • Rotterdam, Holandia, 3015 GD
        • Erasmus Medisch Centrum
  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 2B7
        • University of Alberta Hospital
  • Niemcy
      • Berlin, Niemcy, 10117
        • Charité - Universitätsmedizin Berlin
  • Norwegia
      • Oslo, Norwegia, 0372
        • Oslo universitetssykehus HF- Rikshospitalet
  • Polska
      • Wroclaw, Polska, 50-556
        • Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego we Wroclawiu
  • Portugalia
      • Coimbra, Portugalia, 3000-075
        • Hospitais da Universidade de Coimbra, EPE
      • Lisboa, Portugalia, 1069-166
        • Hospital Curry Cabral
  • Republika Korei
      • Seoul, Republika Korei, 110-744
        • Seoul National University Hospital
      • Seoul, Republika Korei, 120-752
        • Department of Surgery, Yonsei University College of Medicine Severance Hospital
      • Seoul, Republika Korei, 138-736
        • Asan Medical Center, Department of Surgery
  • Stany Zjednoczone
    • California
      • Los Angeles, California, Stany Zjednoczone, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, Stany Zjednoczone, 90095
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, Stany Zjednoczone, 90095
        • UCLA Medical Center
      • Los Angeles, California, Stany Zjednoczone, 90048
        • Cedars-Sinai MedicalCenter
      • Palo Alto, California, Stany Zjednoczone, 94305
        • Stanford University Medical Center
      • Palo Alto, California, Stany Zjednoczone, 94304
        • Stanford School of Medicine
      • San Diego, California, Stany Zjednoczone, 92123
        • California Institute of Renal Research
      • San Diego, California, Stany Zjednoczone, 92123
        • Sharp Memorial Hospital
      • San Diego, California, Stany Zjednoczone, 92123
        • Balboa Institute of Transplantation
      • San Francisco, California, Stany Zjednoczone, 94115
        • California Pacific Medical Center
      • San Francisco, California, Stany Zjednoczone, 94115
        • California Pacific Medical Center - Pacific Campus
      • San Francisco, California, Stany Zjednoczone, 94143
        • UCSF Medical Center - Long Hospital
      • San Francisco, California, Stany Zjednoczone, 94143
        • USCF Medical Center - Connie Frank Transplant Center
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80045
        • University of Colorado Denver
    • Connecticut
      • New Haven, Connecticut, Stany Zjednoczone, 06504
        • Yale-New Haven Hospital
      • New Haven, Connecticut, Stany Zjednoczone, 06510
        • Yale Physicians Building
    • Florida
      • Gainesville, Florida, Stany Zjednoczone, 32610
        • University of Florida
      • Tampa, Florida, Stany Zjednoczone, 33606
        • Tampa General Hospital
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60611
        • Northwestern University Feinberg School of Medicine
      • Chicago, Illinois, Stany Zjednoczone, 60611
        • NUCATS's Clinical Research Unit
    • Michigan
      • Ann Arbor, Michigan, Stany Zjednoczone, 48109
        • University of Michigan Health System
      • Detroit, Michigan, Stany Zjednoczone, 48202
        • Henry Ford Hospital
      • Flint, Michigan, Stany Zjednoczone, 48503
        • Hurley Medical Center
    • Missouri
      • Saint Louis, Missouri, Stany Zjednoczone, 63110
        • Washington University School of Medicine
    • North Carolina
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27514
        • Investigational Drug Services (IDS) / UNC Healthcare
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27514
        • Transplant Clinic/UNC Heathcare
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27599-7211
        • UNC Department of Surgery, Clinical Trials Consortium
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27599-7211
        • UNC Department of Surgery/Abdominal Transplant Division
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27599-7360
        • Division of Pharmacotherapy, School of Pharmacy, University of North Carolina at Chapel Hill
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27599
        • University of North Carolina, Department of Medicine/Nephrology
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19102
        • Hahnemann University Hospital
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19102
        • Drexel University College of Medicine - Hahnemann University Hospital
    • South Carolina
      • Charleston, South Carolina, Stany Zjednoczone, 29425
        • Medical University of South Carolina, Department of Transplantation Surgery
      • Charleston, South Carolina, Stany Zjednoczone, 29425
        • Nephrology clinic
    • Texas
      • Dallas, Texas, Stany Zjednoczone, 75246
        • Baylor University Medical Center
      • Dallas, Texas, Stany Zjednoczone, 75204
        • Dallas Transplant Institute
      • Dallas, Texas, Stany Zjednoczone, 75246
        • Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center
  • Włochy
      • Bologna, Włochy, 40138
        • Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi
    • RM
      • Roma, RM, Włochy, 00168
        • Istituto di Clinica Chirurgica, Universita Cattolica del Sacro Cuore

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

18 lat do 70 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Subjects who successfully completed Study A3921030

Exclusion Criteria:

  • Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants

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: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Treatment Arm 1
Treatment Arm 1 will also receive standard of care medications
Lek: Cyklosporyna
Standard opieki
Eksperymentalny: Treatment Arm 2
Treatment Arm 2 will also receive standard of care medications
Lek: CP-690,550
CP-690,550 tablets dosed BID Months 12-72
Eksperymentalny: Treatment Arm 3
Treatment Arm 3 will also receive standard of care medications
Lek: CP-690,550
CP-690,550 tablets dosed BID Months 12-72

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
Ramy czasowe: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Percentage of Participants With Malignancies
Ramy czasowe: Months 12 through 72.
All treatment-emergent malignancies in Study A3921050 were included as collected on the Malignancy Case Report Form page.
Months 12 through 72.
Least Squares Means of Measured Glomerular Filtration Rate (GFR) (Iohexol Serum Clearance in Milliliters Per Minute [mL/Min])
Ramy czasowe: Month 36
Glomerular filtration rate (GFR): an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous (IV) bolus over 5 minutes immediately after morning dosing of Tofacitinib or CsA on day of GFR evaluation. Blood samples for iohexol (3 millilitres [mL] each to provide a minimum of 1 mL serum) were collected into appropriately labeled tubes containing no additives at 120, 180, 240, and 300 minutes after the end of the iohexol IV bolus. A normal GFR is greater than (>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<) 15 mL/min indicated kidney failure.
Month 36
Percentage of Participants With Progression of Chronic Allograft Lesions at Month 36
Ramy czasowe: Month 36
Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy [cg] + interstitial fibrosis [ci] + tubular atrophy [ct] + vascular intimal thickening [cv]). The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 36 Banff-CS greater than the implantation biopsy score indicated progression of lesions.
Month 36
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Ramy czasowe: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
BPAR was category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
Ramy czasowe: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Ramy czasowe: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Efficacy failure was the first occurrence of BPAR diagnosed by the central pathologist or graft loss including participant death. BPAR (category acute rejection) was interpreted by the central blinded pathologist according to the Banff 97 working classification. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
Ramy czasowe: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: 'suspicious' for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection was calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
Ramy czasowe: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Graft loss was defined as graft nephrectomy, subject death, retransplantation, or return to dialysis for at least 6 consecutive weeks. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. Included data up to 2 months postdose in the clinical Follow-up visit.
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Ramy czasowe: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. Included data up to 2 months postdose in the clinical Follow-up visit.
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Percentage of Participants Discontinuing From the Study
Ramy czasowe: Months 12 through 72.
Discontinuations were due to any reason including those occurring as a result of protocol Amendments 3 and 4.
Months 12 through 72.
Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit
Ramy czasowe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit
Ramy czasowe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit
Ramy czasowe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit
Ramy czasowe: Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
Ramy czasowe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up
Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals.
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up
Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
Ramy czasowe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up
Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals.
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up
Mean Glycosylated Hemoglobin (HBA1c) (Percent [%]) by Visit
Ramy czasowe: Months 24, 36, 48, 60, 72
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
Months 24, 36, 48, 60, 72
Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit
Ramy czasowe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A compund symmetry variance-covariance structure was used.
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Percentage of Participants by Proteinuria Category by Visit
Ramy czasowe: Months 24, 36, 48, 60, 72 and Follow-up
Proteinuria was defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr). Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals.
Months 24, 36, 48, 60, 72 and Follow-up
Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit
Ramy czasowe: Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72

GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Nankivell formula, where:

Creatinine clearance (mL/min) = 6.7/serum creatinine (millimols per litre [mmol/L]) - serum urea (mmol/dL)/2 + actual body weight (kilograms [kg])/4 - 100/Height (metres [m])^2 + (35 for male or 25 for female).

A normal GFR for adults is > 90 mL/min. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.

Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used.
Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit
Ramy czasowe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72

GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR (mL/min) was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)*(140 minus age in years) divided by (72*serum creatinine [mg/dL]). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.

Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used.
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit
Ramy czasowe: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72

GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR (mL/min/1.73 m^2) by MDRD equation = 170 * (serum creatinine [mg/dL])^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen concentration [mg/dL])^(-0.170) * (serum albumin concentration [g/dL])^(0.318). A normal GFR is >90 mL/min/1.73 m^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.

Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used.
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Ramy czasowe: Months 24, 36
SF-36 v2 is a self-administered 36-item generic health status measure with 8 general health concepts which are the weighted sums of the questions in their section: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. Each scale is transformed into a 0 (minimum) to 100 (maximum) scale on the assumption each question carries equal weight. These concepts were also summarized into 2 summary scores; Physical Component Summary and Mental Component Summary (both a 0-100 scale). The 8 subscales, 2 summary scores and transition Question 2 (TR Scale, measured on a scale of 1 [minimum] to 5 [maximum]) were subjected to analysis. Higher domain, summary scores, and TR scale scores indicate better health status. Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. First-order autoregressive variance-covariance structure was used.
Months 24, 36
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Ramy czasowe: Months 24, 36

ESRD-SCL: a 43-item disease specific self-administered questionnaire. Participants' rated the question "At the moment,how much do you suffer?" for each item on a 5 point scale, range (Ra) from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: Cardiac and Renal (CR) dysfunction; Ra 0 to 28, Increased(In) Growth of Gum and Hair (IGGH); Ra 0 to 20, Limited Cognitive Capacity (LCC); Ra 0 to 32, Limited Physical Capacity (LPC); Ra 0 to 40, Side Effects (SEs) of Corticosteroids; Ra 0 to 20, Transplantation Associated Psychological Distress (TAPD); Ra 0 to 32. Total Score: 0 to 172, higher scores indicate greater dysfunction.

Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Months 24, 36
Least Squares Means of Severity of Dyspepsia Assessment (SODA) Subscales at Months 24 & 36
Ramy czasowe: Months 24, 36

SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia; consists of 3 subscales: Pain Intensity (PI, 6-items to assess pain and intensity of abdominal discomfort; Range: 2 to 47, higher score indicates greater pain and abdominal discomfort), Non-Pain Symptoms (NPS, 7-items to assess severity and impact of non-pain symptoms: burping/belching, heartburn, bloating, flatulence, sour taste, nausea, and bad breath; Range: 7 to 35, higher scores indicate increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with abdominal discomfort; Range: 2 to 23, higher scores indicate more satisfaction).

Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Months 24, 36
Mean Trough Levels of Tofacitinib by Visit
Ramy czasowe: Months 18 and 24 (-2 hours, predose, 1 hour, 2 hours), Month 30 (predose, 1 hour and 2 hours), Month 36 (predose, 1, 2, and 4 hours), Months 42, 48, 54, 60, 66, 72 (predose and 2 hours)
The dates and times were recorded for the 6 doses of tofacitinib administered before each scheduled pharmacokinetic (PK) sampling. The participant was instructed to follow a 12 hourly schedule for these 6 doses of tofacitinib, with each dose administered within 1 hour of the scheduled time. Trough samples were collected 0 to 10 minutes prior to the morning dose. 1 hour postdose samples were required within 10 minutes of the nominal time point. Samples taken at -2 hours predose and at time points >1 hour post dose were required within 30 minutes of the nominal time point.
Months 18 and 24 (-2 hours, predose, 1 hour, 2 hours), Month 30 (predose, 1 hour and 2 hours), Month 36 (predose, 1, 2, and 4 hours), Months 42, 48, 54, 60, 66, 72 (predose and 2 hours)
Mean Trough Levels of Cyclosporine by Visit
Ramy czasowe: Predose: Months 18, 24, 36, 48, 60, 72
All CsA samples were taken predose (collected 0 to 10 minutes prior to the morning dose).
Predose: Months 18, 24, 36, 48, 60, 72

Współpracownicy i badacze

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Sponsor

Pfizer

Publikacje i pomocne linki

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Przydatne linki

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)

1 sierpnia 2008

Zakończenie podstawowe (Rzeczywisty)

1 marca 2015

Ukończenie studiów (Rzeczywisty)

1 czerwca 2015

Daty rejestracji na studia

Pierwszy przesłany

9 kwietnia 2008

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 kwietnia 2008

Pierwszy wysłany (Oszacować)

15 kwietnia 2008

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 lutego 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 lutego 2018

Ostatnia weryfikacja

1 lutego 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • A3921050
  • 2008-002345-23 (Numer EudraCT)

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 .

Badania kliniczne na Cyklosporyna

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Warunki

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