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

• Status: Completed
• Trial end date: 2020-05-13
• Target enrollment: 0
• Participant gender: All

Summary

The study will assess the safety, tolerability and efficacy of CSJ137 in chronic hemodialysis patients. It is hypothesized that treatment with CSJ137 may improve the level of hemoglobin in patients on chronic hemodialysis with iron-restricted anemia while reducing the need for dosing with erythropoietin and intravenous iron in these patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.