A Phase 2 Randomized, Multicenter, Active Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Co-administration of CP-690,550 and Mycophenolate Mofetil / Mycophenolate Sodium 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
- 338
- 试验地点
- 1
- 主要终点
- Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant
研究概览
简要总结
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.
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
1
Treatment Arm 1 will also receive standard of care medications
干预措施: Cyclosporine (Drug)
3
Treatment Arm 3 will also receive standard of care medications
干预措施: CP-690,550 (Drug)
2
Treatment Arm 2 will also receive standard of care medications
干预措施: CP-690,550 (Drug)
结局指标
主要结局
Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant
时间窗: Baseline up to Month 6
Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of \>= 0.3 milligram per deciliter (mg/dL) and \>=20 percent (%) from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hours (hrs) of the time of biopsy.
Glomerular Filtration Rate (GFR) at Month 12
时间窗: 2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 12
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 bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is greater than (\>) 90 milliliter per minute (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.
次要结局
- Glomerular Filtration Rate (GFR) at Month 6(2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 6)
- Number of Participants With Progression of Chronic Allograft Lesions at Month 12(Month 12)
- Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant(Baseline up to Month 12)
- Number of Participants With Treated Clinical Acute Rejection(Month 6, 12)
- Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4)(Month 6, 12)
- Number of Participants With Graft Loss(Month 6, 12)
- Number of Participants With Efficacy Failure(Month 6, 12)
- Number of Participants Who Died(Month 6, 12)
- Lymphocyte Subset(Month 1, 3, 6, 12)
- Population Pharmacokinetics (PK)(Pre-dose-2(P-2), Pre-dose(P), 0.5,1,2 hr post-dose(PD) on Day14, Month(M) 3; P,1,2 hr PD on M1; P, 0.5, 2, 4 hr PD on M6; P-2, P, 0.5 hr PD on M9, M12 as per randomization in CP-690,550 treated; P on M3 and P, 2, 4 hr PD on M6 in CsA treated participants)
- Glomerular Filtration Rate (GFR) by The Nankivell Equation(Month 1, 3, 6, 9, 12)
- Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation(Month 1, 3, 6, 9, 12)
- Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation(Month 1, 3, 6, 9, 12)
- Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation(Month 1, 3, 6, 9, 12)
- Number of Participants With Clinically Significant Infections(Baseline up to Month 12)
- 36-Item Short-Form Health Survey (SF-36)(Baseline, Month 6, 12)
- End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL)(Baseline, Month 6, 12)
- Severity of Dyspepsia Assessment (SODA)(Baseline, Month 6, 12)