Last updated on August 2019

A Two-part Single- and Repeat-dose Study of CSJ137 in Anemic Chronic Hemodialysis Patients

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Iron deficiency anemia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Hemodialysis-dependent for at least 2 months prior to screening.
  2. Receiving hemodialysis at least 2 times per week
  3. Receiving erythropoietin (EPO) therapy.
  4. Hemoglobin (Hgb) 8.5 and < 11.5 g/dL at screening.
  5. Ferritin >500 ng/mL and 2000 ng/mL at screening.
  6. TSAT 50% at a minimum of one time point during the 90 days prior to baseline.

Exclusion Criteria:

  1. Known diagnosis of hemochromatosis, bone marrow malignancy, lymphatic malignancy or myelodysplastic syndrome.
  2. History of dialysis AV fistula thrombosis within 2 months prior to screening, or 2 or more episodes of AV fistula thrombosis within 6 months prior to screening.
  3. Liver disease/dysfunction (Child-Pugh score 6), prior liver transplant, heart failure (NYHA Class III or IV); gastrointestinal bleeding.
  4. A positive Hepatitis B surface antigen test result. Patients with Hepatitis C Virus (HCV) infection may be included if all other liver function eligibility criteria are met.
  5. ALT, AST or bilirubin 1.5x ULN within 4 weeks prior to baseline.
  6. Uncontrolled renal osteodystrophy
  7. Conditions predisposing to an increased risk of serious infection, such as an indwelling vascular catheter (central venous line or non-tunneled/acute hemodialysis catheter) or active infection requiring antibiotic therapy at any time during the 2 weeks prior to screening. Tunneled hemodialysis catheters, and other "permanent" catheters are permitted.
  8. Blood transfusion administered within 4 weeks prior to baseline.
  9. Patients who received CSJ137 dose in the past.

Other protocol-defined inclusion/exclusion criteria may apply.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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