Clinical trial NCT00658359: Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplantation
Keywords: Immunosuppression
JAK inhibitor
kidney transplantation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-15
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
timeFrame: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
measure: Percentage of Participants With Malignancies
timeFrame: Months 12 through 72.
measure: Least Squares Means of Measured Glomerular Filtration Rate (GFR) (Iohexol Serum Clearance in Milliliters Per Minute [mL/Min])
timeFrame: Month 36
measure: Percentage of Participants With Progression of Chronic Allograft Lesions at Month 36
timeFrame: Month 36
measure: Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
timeFrame: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
measure: Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
timeFrame: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Secondary outcomes:
measure: Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
timeFrame: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
measure: Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
timeFrame: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
measure: Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
timeFrame: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
measure: Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
timeFrame: Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
measure: Percentage of Participants Discontinuing From the Study
timeFrame: Months 12 through 72.
measure: Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit
timeFrame: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
measure: Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit
timeFrame: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
measure: Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit
timeFrame: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
measure: Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit
timeFrame: Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
measure: Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
timeFrame: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up
measure: Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
timeFrame: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up
measure: Mean Glycosylated Hemoglobin (HBA1c) (Percent [%]) by Visit
timeFrame: Months 24, 36, 48, 60, 72
measure: Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit
timeFrame: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
measure: Percentage of Participants by Proteinuria Category by Visit
timeFrame: Months 24, 36, 48, 60, 72 and Follow-up
measure: Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit
timeFrame: Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
measure: Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit
timeFrame: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
measure: 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
timeFrame: Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
measure: Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
timeFrame: Months 24, 36
measure: Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
timeFrame: Months 24, 36
measure: Least Squares Means of Severity of Dyspepsia Assessment (SODA) Subscales at Months 24 & 36
timeFrame: Months 24, 36
measure: Mean Trough Levels of Tofacitinib by Visit
timeFrame: 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)
measure: Mean Trough Levels of Cyclosporine by Visit
timeFrame: Predose: Months 18, 24, 36, 48, 60, 72
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai MedicalCenter
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford School of Medicine
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: San Diego
country: United States
facility: Balboa Institute of Transplantation
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Pacific Campus
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center - Long Hospital
state: California
city: San Francisco
country: United States
facility: USCF Medical Center - Connie Frank Transplant Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale Physicians Building
state: Connecticut
city: Gainesville
country: United States
facility: University Of Florida
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: NUCATS's Clinical Research Unit
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Chapel Hill
country: United States
facility: Investigational Drug Services (IDS) / UNC Healthcare
state: North Carolina
city: Chapel Hill
country: United States
facility: Transplant Clinic/UNC Heathcare
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Department of Surgery, Clinical Trials Consortium
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Department of Surgery/Abdominal Transplant Division
state: North Carolina
city: Chapel Hill
country: United States
facility: Division of Pharmacotherapy, School of Pharmacy, University of North Carolina at Chapel Hill
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina, Department of Medicine/Nephrology
state: North Carolina
city: Philadelphia
country: United States
facility: Drexel University College of Medicine - Hahnemann University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina, Department of Transplantation Surgery
state: South Carolina
city: Charleston
country: United States
facility: Nephrology Clinic
state: South Carolina
city: Dallas
country: United States
facility: Dallas Transplant Institute
state: Texas
city: Dallas
country: United States
facility: Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital, Department of Renal Medicine
state: New South Wales
city: Adelaide
country: Australia
facility: Central Northern Adelaide Renal and Transplantation Service
state: South Australia
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Anderlecht
country: Belgium
facility: Hopital Erasme
state: Brussels
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
state: RS
city: Sao Paulo
country: Brazil
facility: Hospital do Rim e Hipertensao
state: SP
city: Sao Paulo
country: Brazil
facility: Ambulatorio Pos Transplante do Hospital do Rim a Hipertensao
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital do Rim e Hipertensao
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Praha 4 Krc
country: Czechia
facility: Institut Klinicke a Experimentalni Mediciny
city: Paris Cedex 15
country: France
facility: Hopital Necker
city: Vandoeuvre Les Nancy
country: France
facility: CHRU de Nancy-Brabois - Service de Nephrologie
city: Berlin
country: Germany
facility: Charite - Universitatsmedizin Berlin
city: Roma
country: Italy
facility: Istituto di Clinica Chirurgica, Universita Cattolica del Sacro Cuore
state: RM
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Yonsei University College of Medicine Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Department of Surgery
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Oslo
country: Norway
facility: Oslo universitetssykehus HF- Rikshospitalet
city: Wroclaw
country: Poland
facility: Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego we Wroclawiu
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra, EPE
city: Lisboa
country: Portugal
facility: Hospital Curry Cabral
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: