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 was planned for conduct subsequent to the initiation of Part 1 and would have a different design than Part 1. However, due to internal strategic non-safety related decision, Part 2 is not going to be conducted and the trial will be terminated after Part 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Starting dose is 0.010 mg/kg and dose escalation will proceed with semi-log increase steps to a maximum dose level 10 mg/kg. Subjects receive the treatment via up to 30 minutes intravenous infusion.
Subjects will be dosed with a matching placebo (vehicle control) via up to 30 minutes intravenous infusion.
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Lakewood, Colorado, United States
Novartis Investigative Site
Orlando, Florida, United States
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
safety and tolerability following administration of CSJ137
Time frame: baseline through 115 days after CSJ137 is administered
Minimum active dose of CSJ137 determined by assessment of levels of hemoglobin in blood, without evidence of liver dysfunction or other safety concerns.
to determine the minimum dose of CSJ137 that is active for treatment
Time frame: Hemoglobin response at 28 days post-dose
Peak concentration (Cmax) of CSJ137 in serum
to assess the concentration of CSJ137 in the body over time
Time frame: before CSJ137 is administered, then 0.5 hours and 6 hours after CSJ137 is administered on Day 1. Also 1, 2, 3, 5, 12, 19, 28, and 84 days after CSJ137 is administered
Area under the serum concentration versus time curve (AUC)
to assess the concentration of CSJ137 in the body over time
Time frame: before CSJ137 is administered, then 0.5 hours and 6 hours after CSJ137 is administered on Day 1. Also 1, 2, 3, 5, 12, 19, 28, and 84 days after CSJ137 is administered
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Novartis Investigative Site
Minneapolis, Minnesota, United States
Novartis Investigative Site
Chattanooga, Tennessee, United States
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Ashkelon, Israel
Novartis Investigative Site
Hadera, Israel
Novartis Investigative Site
Jerusalem, Israel
Novartis Investigative Site
Petah Tikva, Israel
...and 3 more locations