NCT03448692终止2 期
A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 47
- 试验地点
- 107
- 主要终点
- Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13
研究概览
简要总结
The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusions in adult subjects with FSGS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Open label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18 years and older who have a confirmed biopsy diagnosis of FSGS.
- •Estimated glomerular filtration rate (eGFR) greater than or equal to 45 ml/min/1.73 m
- •If eGFR is 30 - 45 ml/min/1.73 m2, a recent biopsy (within 12 months prior to Screening) must demonstrate < 50% tubulointerstitial fibrosis.
- •Urine protein:creatinine ratio (UPCR) greater than 1.5 g/g at screening.
- •Treated with at least one but not more than 3 classes of immunosuppressants either alone or in combination, or has a contraindication to use of an immunosuppressant or is intolerant to an immunosuppressant per investigator judgment.
排除标准
- •Diagnosis of collapsing FSGS.
- •Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis.
- •Organ transplant.
- •History of malignancy, with the exception of basal or squamous cell carcinoma that has been treated and fully resolved for a minimum of 5 years.
- •Body mass index (BMI) greater than 45 kg/m
- •Subjects with a history of prior treatment with or use of interferon, lithium, pamidronate, mTOR inhibitors (eg, sirolimus), testosterone/anabolic steroids, anthracycline (eg, doxorubicin), heroin.
研究组 & 干预措施
PF-06730512 Cohort 1
Experimental
Subjects in cohort 1 will receive dose 1 Intravenous (IV) infusion.
干预措施: PF-06730512 (Drug)
PF-06730512 Cohort 2
Experimental
Subjects in cohort 2 will receive dose 2 IV infusion.
干预措施: PF-06730512 (Drug)
PF-06730512 Cohort 3 (optional)
Experimental
Subjects in cohort 3 will receive dose 3 IV infusion.
干预措施: PF-06730512 (Drug)
结局指标
主要结局
Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13
时间窗: Baseline, Week 13
UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function.
次要结局
- Number of Participants With Abnormalities in Electrocardiogram (ECG)(Weeks 3, 7, 11, 13, 17, 21, 25, 33)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(From Day 1 of treatment up to 9 weeks after last dose of study treatment (up to Week 33))
- Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13(Baseline, Weeks 2, 5, 9 and 13)
- Number of Participants With Abnormalities in Laboratory Test Parameters(From Day 1 of treatment up to Week 33)
- Change From Baseline in Body Weight(Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33)
- Change From Baseline in Blood Pressure(Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33)
- Change From Baseline in Pulse Rate(Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33)
- Change From Baseline in Body Temperature(Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33)
- Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13(Baseline, Weeks 3, 5, 9 and 13)
- Serum PF-06730512 Concentration Versus Time Summary(For 12-Week treatment(WT):pre-dose on Day1,8,15,29,43,57,71,follow-up(Fup)visit on Day85,99,113,141,For 24-WT:pre-dose on Day1,8,15,29,43,57,71,85,99,113,127,141,155,Fup visit on Day169,183,197,225;1hour post-dose on Day1,71,155(only applicable for 24-WT))
- Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb)(From Day 1 of treatment up to Week 33)
研究者
研究点 (107)
Loading locations...
相似试验
已完成
2 期
Efficacy and Tolerability of ZD6474 in Patients With Thyroid CancerThyroid CancerNCT00098345Genzyme, a Sanofi Company40
尚未招募
1 期
An Adaptive Open-label Multicentre Phase 1/2 Trial, to Determine the Recommended Phase 2 Dose of CCTx-001, and to Assess Safety, Tolerability, and Clinical Activity in Patients With Relapsed/Refractory Acute Myeloid LeukaemiaAcute Myeloid Leukemia, in RelapseAcute Myeloid Leukemia RefractoryNCT06281847Advesya SAS143
招募中
2 期
A Study of AT-02 in Subjects With Systemic Amyloidosis.Systemic AmyloidosisNCT05951049Attralus, Inc.120
已完成
1 期
Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse EventsSubmental FatNCT05476679Raziel Therapeutics Ltd.48
终止
2 期
Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)Chronic Hepatitis BNCT03434353Gilead Sciences123