NCT02592798已完成2 期
A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change Disease)
Bristol-Myers Squibb27 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年3月9日最近更新:
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
- 入组人数
- 36
- 试验地点
- 27
- 主要终点
- Percentage of Participants in Renal Response at Day 113
研究概览
简要总结
The purpose of this study is evaluate if abatacept is effective and safe in decreasing the level of protein loss in the urine in patients with excessive loss of protein in the urine (nephrotic syndrome) due to either focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). Candidates must have a prior kidney biopsy with either diagnosis. Another kidney biopsy will not be required as part of the study. Candidates must have failed or be intolerant of prior therapy for their kidney disease. The failed or intolerant therapy must include corticosteroids and at least one other drug. Candidates can be adults and children over the age of 6. Abatacept will be administered by venous infusion every 4 weeks.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects ages ≥ 6 years
- •Subjects resistant to corticosteroids, calcineurin inhibitors (cyclosporine and tacrolimus), sirolimus, mycophenolate mofetil (MMF), mycophenolic acid (MPA), or cyclophosphamide or intolerant to at least 2 of these
- •UPCR ≥ 3 at screening
- •FSGS or MCD confirmed by renal biopsy
- •eGFR ≥ 45 for children and adults
- •Concomitant use of angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at stable doses for at least 2 weeks or have intolerance documented in the source documents maintained at the site
排除标准
- •Kidney diseases other than FSGS or MCD
- •Collapsing FSGS
- •Systemic lupus erythematosus
- •Diabetes mellitus, both type 1 and type 2
- •Clinically significant congestive heart failure
- •Post renal transplantation, including relapsing post-transplant FSGS
- •Body mass index (BMI): > 40 in subjects ≥ 18 years of age and ≥ 99% percentile for subjects < 18 years of age
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Abatacept
Experimental
- Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
- Open Label Period (OLE): Abatacept IV administered every 28 days
干预措施: Abatacept (Drug)
Placebo
Placebo Comparator
- Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
- Open Label Period (OLE): Abatacept IV administered every 28 days
干预措施: Normal Saline (Other)
Placebo
Placebo Comparator
- Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
- Open Label Period (OLE): Abatacept IV administered every 28 days
干预措施: D5W (Other)
结局指标
主要结局
Percentage of Participants in Renal Response at Day 113
时间窗: From first dose to 113 days following first dose of the indicated period (113 days for Double-Blind Period, 226 days for Open Label Period)
Renal Response is defined as the presence of all the following criteria: PROTEINURIA: Reduction of baseline urine protein/creatinine ratio (UPCR) of \>= 50% and to less than 3. RENAL FUNCTION: No worsening of baseline estimated glomerular filtration rate (eGFR) defined as within normal range if normal at baseline or ≥ 75% baseline value if below normal at baseline.
次要结局
- Number of Participants Experiencing Adverse Events of Special Interest(From first dose on day 1 to 56 days following last dose (approximately 330 days))
- Maximum Observed Serum Concentration (Cmax) of Abatacept(Day 85 after first dose in the Double Blind Period)
- Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 113(From baseline (measured at day 1 of study) to 113 days following first dose administered in the indicated treatment period (113 days for Double-Blind Period, 226 days for Open Label Period))
- Minimum Blood Plasma Concentration (Cmin) of Abatacept - Pediatric Participants(From first dose to 113 days after first dose in the Double Blind Period. Data collected on day 15, day 29, day 57, day 85 and day 113)
- Time to Reach Peak Serum Concentration (Tmax(h)) of Abatacept(Day 85 after first dose in the Double Blind Period)
- Percentage of Participants Achieving Complete Remission at Day 113(From first dose to 113 days following first dose of the indicated period (113 days for Double-Blind Period, 226 days for Open Label Period))
- Mean Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) at Day 113 - Pediatric Participants(From baseline (measured at day 1 of study) to 113 days following first dose administered in the Double-Blind Period)
- Number of Participants Experiencing Adverse Events(From first dose in the indicated period to 56 days following last dose in the indicated period (169 days for the Double-Blind Period, up to 337 days for the Cumulative Abatacept Safety Period))
- Minimum Blood Plasma Concentration (Cmin) of Abatacept - Adult Participants(From first dose to 113 days after first dose in the Double Blind Period. Data collected on day 15, day 29, day 57, day 85 and day 113)
- Mean Change From Baseline in Serum Albumine at Day 113(From baseline (measured at day 1 of the study) to 113 days following first dose administered in the indicated treatment period (113 days for Double-Blind Period, 226 days for Open Label Period))
- Area Under the Serum Concentration Time Curve Over a Dosing Interval (AUC(TAU)) of Abatacept(From Day 85 to Day 113 in the Double Blind Period)
- Mean Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) at Day 113 - Adult Participants(From baseline (measured at day 1 of study) to 113 days following first dose administered in the Double-Blind Period)
- Percentage of Participants With Positive Antibody Response Relative to Baseline(From baseline (day 1) to 168 days following last dose (up to 15 months). Results at day 113 from first dose, day 56, day 84 and day 168 after last dose are presented)
研究者
研究点 (27)
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