Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 4
- 主要终点
- Dose tolerance
研究概览
简要总结
Phase 2 basket trial including 2 open-label single-arm cohorts: REPAIR CKD cohort and REPAIR Dialysis cohort. Open label colchicine 0.3 mg daily for 8 weeks followed, in patients who tolerated the 0.3 mg dose, by forced titration to 0.6 mg daily for 8 weeks.
详细描述
The REPAIR CKD cohort will enroll 100 patients with chronic kidney disease not requiring dialysis. The REPAIR Dialysis cohort will enroll 100 patients with chronic kidney disease requiring chronic maintenance dialysis. Each participant will be followed for up to 17 weeks, to determine among adults with severe chronic kidney disease not requiring dialysis and (separately) in those requiring dialysis, the proportion who, over 8 weeks of treatment, discontinue colchicine 1) 0.3 mg daily and 2) 0.6 mg daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One of either:
- •1.2 Estimated GFR using CKD-EPI 2021 equation of ≤30 ml/min/1.73m2 on at least two occasions separated by at least 2 months and do not yet require dialysis and are not expected by their treating nephrologist to require dialysis in the next 6 months (REPAIR CKD cohort), or 1.3 receiving chronic maintenance dialysis 2 or more times per week for the previous 90 days (REPAIR Dialysis cohort);
- •Age ≥18 years
- •Provide informed consent to participate.
排除标准
- •Currently treated with and cannot withdraw colchicine due to medical necessity; or
- •Known allergy/sensitivity to colchicine; or
- •Prior self-reported intolerance to colchicine at a dose of 0.6 mg daily or lower; or
- •Currently pregnant or planning to become pregnant or breastfeed during the study; or
- •Of childbearing potential AND do not have a negative pregnancy test OR do not agree to use two forms of contraception for the duration of the study; or
- •Anticipated living donor renal transplant within the next 6 months; or
- •Using a strong inhibitor of p-glycoprotein or strong inhibitor of CYP3A4 in the last 14 days; or
- •B12 deficiency not managed with intramuscular supplementation; or
- •Uncontrolled chronic diarrhea; or
- •Cirrhosis, or chronic active hepatitis; or
- •Pre-existent neuromuscular disease or persistent serum CK level > 3 times the upper limit of normal as measured within the past 60 days and determined to be non-transient through repeat testing; or
- •Patient with any of the following within the past 60 days:
- •white blood cell count < 3.0 X 109/L; or
- •platelet count <110 X 109/L; or
- •ALT or AST > 3 times the upper limit of normal (ULN); or
- •total bilirubin > 2 times ULN and not due to Gilbert syndrome.
- •Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
研究组 & 干预措施
REPAIR CKD cohort
Patients will receive open label colchicine 0.3 mg daily for 8 weeks followed, in patients who tolerated the 0.3 mg dose, by forced titration to 0.6 mg daily for 8 weeks.
干预措施: Colchicine (Drug)
REPAIR Dialysis cohort
Patients will receive open label colchicine 0.3 mg daily for 8 weeks followed, in patients who tolerated the 0.3 mg dose, by forced titration to 0.6 mg daily for 8 weeks.
干预措施: Colchicine (Drug)
结局指标
主要结局
Dose tolerance
时间窗: Up to 17 weeks
Proportion of participants who permanently discontinue colchicine at either the 0.3 mg daily dose or 0.6 mg daily dose (to estimate the proportion who would discontinue the study drug at the 0.6 mg daily dose without titration).
Early discontinuations
时间窗: Up to 17 weeks
Proportion of participants who permanently discontinue colchicine at the 0.3 mg daily dose.
次要结局
- Reason for drug discontinuation(Up to 17 weeks)
- Major Side Effects(Up to 17 weeks)
- Drug adherence(Up to 17 weeks)