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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient of a first-time kidney transplant
- •Between the ages of 18 and 70 years, inclusive
排除标准
- •Recipient of any non-kidney transplant
研究组 & 干预措施
CP-690,550 15 mg BID
干预措施: CP-690,550 (Drug)
CP-690,550 30 mg BID
干预措施: CP-690,550 (Drug)
tacrolimus
干预措施: tacrolimus (Drug)
结局指标
主要结局
Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6
时间窗: Baseline up to Month 6
BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.
Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 6
时间窗: Month 6
GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25\*body weight) minus (0.5\*serum urea) minus (100 per square height) plus (35 for male/25 for female). A normal GFR is \>90 milliliter/minute (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.
次要结局
- Number of Participants With Treatment Failure(Month 3, 6)
- Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3(Baseline up to Month 3)
- Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)(Month 3, 6)
- Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)(Month 3, 6)
- Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)(Month 3, 6)
- Number of Participants With Efficacy Failure(Month 3, 6)
- Number of Participants With Graft Loss(Month 6)
- Number of Participants Who Died(Month 6)
- Number of Participants With Rejection(Month 3, 6)
- Population Pharmacokinetics (PK)(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)
- Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets(Baseline, Day 14, Month 1, 3, 6)
- Reticulocyte Count(Baseline, Day 14, Month 1, 3, 6)
- Trough Levels of Tacrolimus (TAC)(Pre-dose on Day 14, Month 1, 3, 6)
- Number of Participants With Drug Usage(Baseline, Day 14, Month 1, 3, 6)
- 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)(Baseline, Month 6)
- End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)(Baseline, Month 6)
- Healthcare Resource Utilization Questionnaire (HCRUQ)(Baseline, Month 6)
- Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question(Month 6)
- Glomerular Filtration Rate (GFR) by Cockcroft-Gault(Day 14, Month 1, 3, 6)
- Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation(Day 14, Month 1, 3, 6)
- Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)(Day 14, Month 1, 3, 6)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)(Baseline up to Month 8 (2 months follow-up))
- Number of Participants With First Clinically Significant Infection(Month 3, 6)
- Number of Participants With New Onset Diabetes Mellitus (NODM)(Month 3, 6)
- Fasting Serum Glucose Levels(Baseline, Day 14, Month 1, 3, 6)
- Number of Participants With Hypercholesterolemia(Baseline, Day 14, Month 1, 3, 6)
- Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels(Baseline, Day 14, Month 1, 3, 6)
- Number of Participants With Hypertriglyceridemia(Baseline, Day 14, Month 1, 3, 6)
- Supine Systolic and Diastolic Blood Pressure (BP)(Baseline, Day 2, 3, 14, Month 1, 3, 6)
- Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load(Baseline, Month 1, 3, 6 for CMV; Baseline, Day 14, Month 1, 3, 6 for EBV)
- BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load(Baseline, Month 1, 3, 6)
- Number of Participants With Cytomegalovirus (CMV) Disease(Month 3, 6)
- Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil(Baseline, Day 14, Month 1, 3, 6)
- Absolute Platelet Levels(Baseline, Day 14, Month 1, 3, 6)
- Hemoglobin Level(Baseline, Day 14, Month 1, 3, 6)
- Hematocrit Level(Baseline, Day 14, Month 1, 3, 6)
- Alanine Aminotransferase (ALT) Level(Baseline, Day 14, Month 1, 3, 6)
- Electrocardiogram (ECG) Parameters(Baseline, Month 3, 6)
- Number of Participants With Discontinuation(Month 1, 2, 3, 4, 5, 6)