end-stage renal disease
Conditions
Interventions
Intravenous administration of ARA 290 or placebo (6 doses).
Sponsors
Araim Pharmaceuticals, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study endpoints are safety and tolerability parameters (12-lead ECG, haematology, blood biochemistry including hs-CRP, adverse events), pharmacokinetics of ARA 290 (venous blood samples at 3, 6 and 12 min). Blood sampling for hs-CRP will be performed at the start of each hemodialysis session. If a reduction in hs-CRP is seen in this study, blood samples that will be collected in the study may be subjected to additional analyses to further characterize the anti-inflammatory effects of ARA 290. | — |
Countries
Netherlands
Outcome results
None listed