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

This posting discloses information about Part 1 of CCSJ137X2201. Another part, Part 2, of
this trial is planned for conduct subsequent to the initiation of Part 1 and will have a
different design than Part 1. The details of the design for this additional part are planned
for disclosure in advance of conduct of Part 2.

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 defined asthe coexistence of all of the following at
screening (1) intact PTH ≥ 750 pg/mL, (2) serum phosphate above the upper limit of the
lab normal range, and (3) calcium x phosphate product > 75 mg2/dL2 (6.05 mmol2/L2).

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. Cancer patients who are actively undergoing chemotherapy at screening or who have
received chemotherapy within 3 months prior to screening.

10. Patients who received CSJ137 dose in the past.

Other protocol-defined inclusion/exclusion criteria may apply.