NCT02848131Enrolling By Invitation2 期
Senescence, Frailty, and Mesenchymal Stem Cell Functionality in Chronic Kidney Disease: Effect of Senolytic Agents
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Change in proportion of senescent cells (representing the total senescent cell burden) present
研究概览
简要总结
The study goal is to assess the effect of senescent cell clearance on senescence burden, physical ability or frailty, and adipose tissue-derived mesenchymal stem cell (MSC) functionality in patients with chronic kidney disease (CKD).
详细描述
The proposed studies will examine cellular senescence and the effect of senolytic therapy on senescent cell burden, frailty, and adipose-derived mesenchymal stem cell function in individuals with diabetic chronic kidney disease.
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-80 years
- •Chronic kidney disease estimated glomerular filtration rate (eGFR) 15-45 ml/min/1.73m2
- •Diabetes mellitus and taking diabetes medications
排除标准
- •Concomitant glomerulonephritis,
- •Nephrotic syndrome,
- •Solid organ transplantation,
- •Autosomal dominant or recessive polycystic kidney disease,
- •Known renovascular disease,
- •Active immunosuppression therapy,
- •Hemoglobin A1c≥10% at screening,
- •History of active substance abuse (including alcohol) within the past 2 years,
- •Current alcohol abuse (>3 alcoholic beverages/day or >21 per week),
- •Body weight >150 kg or body mass index>50
- •Human immunodeficiency virus infection
- •Active hepatitis B or C infection
- •Tyrosine kinase inhibitor therapy
- •Known hypersensitivity or allergy to dasatinib or quercetin
- •Inability to give informed consent
- •Uncontrolled systemic lupus erythematosus
- •Uncontrolled pleural/pericardial effusions or ascites
- •New invasive cancer except non-melanoma skin cancers
- •Invasive fungal or viral infection
- •Inability to tolerate oral medications
- •Total bilirubin>2x upper limit of normal
- •Subjects taking medications that are sensitive to substrates or substrates with a narrow therapeutic range for CYP3A4, CYP2C8, CYP2C9, or CYP2D6 or strong inhibitors or inducers of CYP3A4 (e.g. cyclosporine, tacrolimus or sirolimus). If antifungals are absolutely necessary from an infectious disease perspective, then they will be allowed only if the levels are therapeutic.
- •Subjects on strong inhibitors of CYP3A
- •Subjects on therapeutic doses of anticoagulants (Warfarin (Coumadin);Rivaroxaban (Xarleto); Apixaban (Eliquis); Dabigatran (Pradaxa, Prazaxa) or Other).
- •Subjects on antiplatelet agents ((Clopidogrel (Plavix); Dipyridamole + Asprin (Aggrenox); Ticagrelor (Brilinta); Prasugrel (Effient); Ticlopidine (Ticlid) or Other) who are unable or unwilling to reduce or hold therapy prior to and during the 3-day drug dosing. Subjects may continue their previous regimen on day
- •Subjects on quinolone antibiotic therapy for treatment or for prevention of infections within 10 days
- •Subjects taking H2-antagonists or proton pump inhibitors and unwilling to discontinue therapy 1 week prior and 2 weeks following enrollment.
- •Corrected QT interval (QTc)>450 msec
- •Presence of any condition that the Investigator believes would put the subject at risk or would preclude the patient from successfully completing all aspects of the trial.
研究组 & 干预措施
Group 1: Observational
No Intervention
Observational Only
Group 2: Dasatinib & Quercetin
Active Comparator
The drugs dasatinib and quercetin will be used in this arm
干预措施: Group 2: Dasatinib (Drug)
Group 2: Dasatinib & Quercetin
Active Comparator
The drugs dasatinib and quercetin will be used in this arm
干预措施: Group 2: Quercetin (Drug)
结局指标
主要结局
Change in proportion of senescent cells (representing the total senescent cell burden) present
时间窗: Baseline, Day 14
Assessment of senescence markers in skin, fat, and/or blood at baseline and day 14.
次要结局
- Change in proportion of senescent mesenchymal stem cells present(Baseline, Day 14)
- Change in mesenchymal stem cell function(Baseline, Day 14)
- Change in Frailty index score(Baseline, Day 14)
- Change in kidney function(Baseline, Day 14, Month 4, Month 12)
研究者
LaTonya J. Hickson
Principal Investigator
Mayo Clinic
研究点 (4)
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