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

Therapuetic Areas:Hematology
Age Range:18 - Any
Start Date:September 22, 2015
End Date:February 7, 2020
Contact:Novartis Pharmaceuticals

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A First-in-human, Two-part (Open Label, and Randomized/Double Blind/Placebo Controlled), Single- and Repeat-dose Study of CSJ137 in Erythropoietin-treated Chronic Hemodialysis Patients With Functional Iron-deficiency Anemia

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.

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

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.
We found this trial at
San Diego, California 92123
San Diego, CA
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Chattanooga, Tennessee 37404
Chattanooga, TN
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Chicago, Illinois 60612
Chicago, IL
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Lakewood, Colorado 80228
Lakewood, CO
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Minneapolis, Minnesota 55402
Minneapolis, MN
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Orlando, Florida 32806
Orlando, FL
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