Clin2
NCT07119372Possibly a fitRecruiting

New drug for anemia from kidney disease on dialysis

AnemiaChronic Kidney DiseaseChronic Kidney Disease Patients on HemodialysisChronic Kidney Disease 5D

Part of Blood & lymphatic, Kidney & urinary, Women’s health & pregnancy clinical trials.

This trial tests a new drug called BCD-131 (a biosimilar to Mircera) for treating anemia in people with kidney disease on dialysis. It compares the new drug to the standard treatment to see if it works just as well and is safe.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
228 people
Ages
18 years to 75 years
Study type
Interventional

Who can take part

  • You must be 18 to 75 years old.
  • You must have end-stage kidney disease and be on dialysis (hemodialysis or peritoneal dialysis) for at least 90 days.
  • You must have been using a steady dose of a medicine called erythropoietin (like Epogen, Procrit, or Aranesp) for at least 90 days.
  • Your hemoglobin level must be between 100 and 120 g/L (about 10 to 12 g/dL).
  • Your iron, vitamin B12, and folic acid levels must be normal.
  • You cannot have other causes of anemia, recent blood transfusions, active infections, certain heart conditions, or a history of blood clots in the last 6 months.

View the official record on ClinicalTrials.gov

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