NCT01233869已完成2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety, Clinical Activity And Pharmacokinetics Of Bosutinib (PF-05208763) Versus Placebo In Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 172
- 试验地点
- 64
- 主要终点
- Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25
研究概览
简要总结
This purpose of this study is to determine if bosutinib reduces the rate of kidney enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than or equal to 60 mL/min/1.73m2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 18 to 50 years old at the time of consent.
- •Documented diagnosis of ADPKD (PKD-1 or PKD-2 genotypes allowed).
- •Total kidney volume ≥ 750 cc, as measured by centrally evaluated MRI.
排除标准
- •eGFR < 60 mL/min/1.73m
- •Uncontrolled hypertension (defined as systolic blood pressure ≥140 or diastolic blood pressure ≥90 mm Hg).
- •Any previous exposure to the bosutinib test article or receipt of other polycystic kidney disease (PKD) therapies.
研究组 & 干预措施
Cohort A
Experimental
干预措施: Bosutinib (Drug)
Cohort B
Experimental
干预措施: Bosutinib (Drug)
Cohort C
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25
时间窗: Baseline and Month 25 (end of Initial Treatment Period Visit [ITPV])
TKV was measured by centrally evaluated Magnetic Resonance Imaging (MRI).
次要结局
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination(Baseline, Month 12, Month 24, Month 25 (end of ITPV), and early termination)
- Time to First Occurrence or Worsening of Hypertension(Baseline up to Month 25 (end of ITPV))
- Time to First Occurrence or Worsening of Back and/or Flank Pain(Baseline up to Month 25 (end of ITPV))
- Time to First Occurrence of Gross Hematuria(Baseline up to Month 25 (end of ITPV))
- Time to First Occurrence of Proteinuria(Baseline up to Month 25 (end of ITPV))
- Time to First Occurrence of End-Stage Renal Disease (ESRD) Requiring Dialysis >=56 Days(Baseline up to Month 25 (end of ITPV))
- Number of Participants With High Blood Urea Nitrogen (BUN) Levels(Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV))
- Number of Participants With High Serum Creatinine (SCr) Levels(Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV))
- Maximum Observed Plasma Concentration (Cmax) of Bosutinib(Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose))
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bosutinib(Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose))
- Area Under the Concentration-Time Profile From Time 0 to the Dosing Interval (AUCtau) of Bosutinib(Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose))
- Lowest Concentration Observed During the Dosing Interval (Cmin) of Bosutinib(Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose))
- Observed Accumulation Ratio (Rac) of Bosutinib(Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose))
- Apparent Oral Clearance (CL/F) of Bosutinib(Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose))
- Apparent Volume of Distribution (Vz/F) of Bosutinib(Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose))
- Terminal Elimination Half-Life (t1/2) of Bosutinib(Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose))
- Change From Baseline in Kidney Disease Quality of Life (KDQoL)-36 Scale Scores at Month 25(Baseline and end of ITPV (Month 25))
研究者
研究点 (64)
Loading locations...
相似试验
已完成
1 期
Bosutinib In Subjects With Renal ImpairmentRenal Disease, End-StageRenal Insufficiency, ChronicRenal Insufficiency, AcuteNCT01233882Pfizer34
已完成
2 期
A phase 2 study of BOsutinib Gradual Increase as a second or third line treatment for chronic myeloid leukemia in chronic phasechronic myeloid leukemiaJPRN-UMIN000032282Division of Hematology, Respiratory diseases and Oncology, Faculty of Medicine, Saga University35
进行中（未招募）
2 期
BOsutinib Gradual Increase trialchronic myeloid leukemiachornic myeloid leukemiaC921JPRN-jRCTs071180012Kimura Shinya35
已完成
2 期
Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by SurgeryKidney CancerNCT00459979Case Comprehensive Cancer Center30
终止
2 期
Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast CancerAdvanced Breast CancerNCT00793546Pfizer42