Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis(HD) Patients

Launched by AMERICAN REGENT, INC. · Nov 13, 2024

Keywords

ClinConnect Summary

This is a randomized open label multi-center study of two parallel patient groups undergoing hemodialysis. Group A will receive 200 mg of iron sucrose, while Group B will receive 100 mg of iron sucrose during the study. The duration of the study for each patient will be approximately 3 weeks including a screening phase, a treatment visit and a follow-up visit.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males or females over 18 years of age and able to give informed consent.
• • Undergoing hemodialysis.
• • If receiving epoetin α, then the dose was stable.
• • Percentage serum transferrin saturation (TSAT) \<50% and serum ferritin \<800 ng/mL.
• • Absence of infection, malignancy, or surgery in the month prior to study start.
• • Intolerance of other iron products did not preclude participation in this study.
• Exclusion Criteria:
• • Known sensitivity to any component of Venofer®.
• • Suffering from concomitant severe diseases of the liver, cardiovascular system, severe psychiatric disorders or other conditions which, in the opinion of the investigator, made participation unacceptable.
• • Serious bacterial, viral infection, or other acute infectious illness (e.g., hepatitis) unless completely resolved at least 4 weeks prior to inclusion in the study.
• • Pregnancy or lactation.
• • HIV positive by medical history or laboratory test (optional), or active hepatitis.
• • Anemia caused by diseases (including systemic lupus erythematosus (SLE), rheumatoid arthritis, myeloma, or hereditary hemoglobinopathies) other than chronic renal failure or iron deficiency.
• • Asthma.
• • Clinical evidence of gastrointestinal bleeding.
• • Would probably require blood transfusion or might undergo a renal transplant during the study.
• • Anticipated surgery of any kind during the study other than vascular access surgery.
• • Received an investigational drug within 30 days prior to screening.
• • Previously participated in another Venofer® study.