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

Phase 2

Completed

Conditions: 10038430
end-stage renal disease

Registration Number: NL-OMON33202

Lead Sponsor: Araim Pharmaceuticals, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The study endpoints are safety and tolerability parameters (12-lead ECG,<br /><br>haematology, blood biochemistry including hs-CRP, adverse events),<br /><br>pharmacokinetics of ARA 290 (venous blood samples at 3, 6 and 12 min). Blood<br /><br>sampling for hs-CRP will be performed at the start of each hemodialysis<br /><br>session. If a reduction in hs-CRP is seen in this study, blood samples that<br /><br>will be collected in the study may be subjected to additional analyses to<br /><br>further characterize the anti-inflammatory effects of ARA 290.</p><br>

Secondary Outcome Measures