Clinical trial NCT00106639: A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients
Official title: A 6-Month, Phase 2, Multicenter, Randomized, Open-Label, Comparative Study Of 2 Dose Levels Of CP-690,550 Administered Concomitantly With IL-2 Receptor Antagonist Induction Therapy, Mycophenolate Mofetil And Corticosteroids Versus A Tacrolimus-Based Immunosuppressive Regimen For The Prevention Of Allograft Rejection In De Novo Renal Allograft Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplantation
Keywords: tofacitinib
CP-690550
kidney transplant
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-03-29
Enrollment: 61
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 Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the same treatment groups.


Eligibility criteria: Inclusion Criteria:

* Recipient of a first-time kidney transplant
* Between the ages of 18 and 70 years, inclusive

Exclusion Criteria:

* Recipient of any non-kidney transplant

Primary outcomes:
measure: Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6
timeFrame: Baseline up to Month 6
measure: Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Number of Participants With Treatment Failure
timeFrame: Month 3, 6
measure: Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3
timeFrame: Baseline up to Month 3
measure: Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)
timeFrame: Month 3, 6
measure: Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)
timeFrame: Month 3, 6
measure: Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)
timeFrame: Month 3, 6
measure: Number of Participants With Efficacy Failure
timeFrame: Month 3, 6
measure: Number of Participants With Graft Loss
timeFrame: Month 6
measure: Number of Participants Who Died
timeFrame: Month 6
measure: Number of Participants With Rejection
timeFrame: Month 3, 6
measure: Population Pharmacokinetics (PK)
timeFrame: Pre-dose on Day 1, 3, 7, 14, Month 1, 3, 6, between 1 to 2 hours post-dose at Month 3 and between 3 to 4 hours post-dose at Month 6
measure: Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets
timeFrame: Baseline, Day 14, Month 1, 3, 6
measure: Reticulocyte Count
timeFrame: Baseline, Day 14, Month 1, 3, 6
measure: Trough Levels of Tacrolimus (TAC)
timeFrame: Pre-dose on Day 14, Month 1, 3, 6
measure: 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)
timeFrame: Baseline, Month 6
measure: End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)
timeFrame: Baseline, Month 6
measure: Healthcare Resource Utilization Questionnaire (HCRUQ)
timeFrame: Baseline, Month 6
measure: Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question
timeFrame: Month 6
measure: Glomerular Filtration Rate (GFR) by Cockcroft-Gault
timeFrame: Day 14, Month 1, 3, 6
measure: Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation
timeFrame: Day 14, Month 1, 3, 6
measure: Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)
timeFrame: Day 14, Month 1, 3, 6
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to Month 8 (2 months follow-up)
measure: Number of Participants With First Clinically Significant Infection
timeFrame: Month 3, 6
measure: Number of Participants With New Onset Diabetes Mellitus (NODM)
timeFrame: Month 3, 6
measure: Fasting Serum Glucose Levels
timeFrame: Baseline, Day 14, Month 1, 3, 6
measure: Number of Participants With Hypercholesterolemia
timeFrame: Baseline, Day 14, Month 1, 3, 6
measure: Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels
timeFrame: Baseline, Day 14, Month 1, 3, 6
measure: Number of Participants With Hypertriglyceridemia
timeFrame: Baseline, Day 14, Month 1, 3, 6
measure: Supine Systolic and Diastolic Blood Pressure (BP)
timeFrame: Baseline, Day 2, 3, 14, Month 1, 3, 6
measure: Number of Participants With Drug Usage
timeFrame: Baseline, Day 14, Month 1, 3, 6
measure: Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load
timeFrame: Baseline, Month 1, 3, 6 for CMV; Baseline, Day 14, Month 1, 3, 6 for EBV
measure: BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load
timeFrame: Baseline, Month 1, 3, 6
measure: Number of Participants With Cytomegalovirus (CMV) Disease
timeFrame: Month 3, 6
measure: Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil
timeFrame: Baseline, Day 14, Month 1, 3, 6
measure: Absolute Platelet Levels
timeFrame: Baseline, Day 14, Month 1, 3, 6
measure: Hemoglobin Level
timeFrame: Baseline, Day 14, Month 1, 3, 6
measure: Hematocrit Level
timeFrame: Baseline, Day 14, Month 1, 3, 6
measure: Alanine Aminotransferase (ALT) Level
timeFrame: Baseline, Day 14, Month 1, 3, 6
measure: Electrocardiogram (ECG) Parameters
timeFrame: Baseline, Month 3, 6
measure: Number of Participants With Discontinuation
timeFrame: Month 1, 2, 3, 4, 5, 6
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Palo Alto
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Stanford
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Livingston
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Busque S, Leventhal J, Brennan DC, Steinberg S, Klintmalm G, Shah T, Mulgaonkar S, Bromberg JS, Vincenti F, Hariharan S, Slakey D, Peddi VR, Fisher RA, Lawendy N, Wang C, Chan G. Calcineurin-inhibitor-free immunosuppression based on the JAK inhibitor CP-690,550: a pilot study in de novo kidney allograft recipients. Am J Transplant. 2009 Aug;9(8):1936-45. doi: 10.1111/j.1600-6143.2009.02720.x.