A Single-Centre, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ARA 290 Administered Intravenously to End-Stage Renal Disease Patients - ARA 290 ESRD

Araim Pharmaceuticals, Inc0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Be able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff;
•Willing to comply with study restrictions;
•Between 18 and 65 years of age (inclusive).
•Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive);
•Diagnosis of clinically stable ESRD, as determined by the investigator;
•Requiring regular dialysis therapy for at least 12 weeks prior to first administration of study agent;
•Receiving treatment with IV or SC erythropoietin receptor agonist for a minimum of 8 weeks prior to administration of study agent, requiring doses to remedy EPO-resistance, with evidence of stable hemoglobin levels;
•Baseline hemoglobin values between 9.0 and 12.0 g/dL (5.6 - 7.5 mmol/L) before entering the study;
•CRP levels of at least 7 mg/L;
•Normal serum folate and vitamin B12 levels at screening;
•Having a creatinine clearance below 15 mL/min (chronic kidney disease stage 5), based on the Cockcroft-Gault equation

•Clinically relevant abnormal history of physical and mental health other than conditions related to chronic kidney disease of patient, as determined by medical history taking (as judged by the investigator);
•Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings other than conditions related to chronic kidney disease of patient (as judged by the investigator);
•Subject has uncontrolled hypertension;
•Subject is unable to refrain from the use of disallowed concomitant medication from one week prior to the first study drug administration until follow-up assessments;
•Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food;
•Subject has a history of syncopal episodes;
•Subjects that received a vaccination or immunization within the last month;
•Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year;
•Subject has undergone major surgery within six months prior to screening;
•Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject.

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