NCT05405556已完成2 期
Sotagliflozin Safety and Tolerability Among Renal Transplant Recipients
Martina McGrath, MD2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年10月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Reversibility of eGFR changes
研究概览
简要总结
This is an investigator-initiated, randomized controlled trial in adult KTRs (N=50) with stable allograft function to assess: 1) the reversibility of the expected acute changes in eGFR with sotagliflozin (donated by Lexicon); 2) proportion of patients completing the protocol according to different eGFR reporting strategies (using a predefined algorithm to manage the expected pharmacological effect of sotagliflozin on eGFR); 3) safety and tolerability of sotagliflozin.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years
- •Recipients of kidney transplant with stable eGFR*
- •eGFR-creatinine (CKD-EPI 2021) ≥25 mL/min/1.73 m2
- •Informed consent
- •Stable eGFR will be ascertained by careful chart review establishing that the patient's current graft has been functioning for at least 12 months post-transplantation, patients have not been treated for acute rejection within the prior 3 months, and a creatinine-based eGFR is stable (two consecutive measurements separated by at least 28 days within 5 mL/min/1.73 m2) and ≥25 mL/min/1.73 m2.
排除标准
- •Recurrent urinary tract infections (>2 episodes/year or antibiotic prophylaxis)
- •Biopsy-proven acute rejection within 12 weeks
- •Screening serum potassium >5.5 mmol/L
- •Uncontrolled hypertension (systolic blood pressure >180/100 mmHg)
- •New York Heart Association (NYHA) Class IV HF
- •Myocardial infarction, unstable angina, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 12 weeks
- •History of diabetic ketoacidosis
- •Type 1 Diabetes Mellitus
- •Hereditary glucose-galactose malabsorption or primary renal glucosuria
- •Liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis); Alanine aminotransferase (ALT) levels >2.0 times the upper limit of normal (ULN) or total bilirubin >1.5 times the ULN, unless consistent with Gilbert's disease
- •Malignancy within 5 years (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ, or a malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
- •Human immunodeficiency virus antibody positive
- •Major surgery within 12 weeks
- •Atraumatic amputation within past 12 months of screening, or an active skin ulcer, osteomyelitis, gangrene, or critical ischemia of the lower extremity within 6 months of screening
- •Combination use of ACEi and ARB
- •Current use of an SGLT2 inhibitor (within 12 weeks prior to randomization)
- •Known allergies, hypersensitivity, or intolerance to SGLT2i or its excipients
- •Digoxin plasma level >1.2 ng/mL
- •Clofibrate, fenofibrate, dronedarone, or ranolazine treatment that has not been at a stable dose in the 30 days prior to screening or randomization, or a dose adjustment is expected
- •Received an active investigational drug (including vaccines) other than a placebo agent, or used an investigational medical device within 12 weeks before Day 1/baseline
- •Pregnant or breast-feeding or planning to become pregnant or breast-feed during the study
- •Women of childbearing potential not willing to use a highly-effective method(s) of birth control, or who are unwilling or unable to be tested for pregnancy
- •Any condition that in the opinion of the investigator would make participation not in the best interest of the subject
结局指标
主要结局
Reversibility of eGFR changes
时间窗: 16 weeks total
Following 12 weeks of open-label drug treatment, participants will stop drug and be followed for a further four weeks (16 weeks total). Reversibility will be assessed as the proportion of patients who return to baseline eGFR (+/- 10%) by the end of the 4-week off-treatment period.
次要结局
- Proportion of patients successfully completing the full treatment protocol, according to randomized groups(16 weeks total)
研究者
Martina McGrath, MD
Associate Physician, Instructor in Medicine, Principal Investigator
Brigham and Women's Hospital
研究点 (2)
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