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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary: 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.
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome:

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: baseline through 115 days after CSJ137 is administered ]
  safety and tolerability following administration of CSJ137
• Minimum active dose of CSJ137 determined by assessment of levels of transferrin saturation and hemoglobin in serum and blood, respectively [ Time Frame: Hemoglobin response at 28 days post-dose ]
  to determine the minimum dose of CSJ137 that is active for treatment

Original Primary Outcome:

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: baseline through 115 days after CSJ137 is administered ]
  safety and tolerability following administration of CSJ137
• Minimum active dose of CSJ137 determined by assessment of levels of transferrin saturation and hemoglobin in serum and blood, respectively [ Time Frame: before CSJ137 is administered, then 0.5 hours and 6 hours after CSJ137 is administered on Day 1. Also 2, 3, 4, 6, 13, 20, and 29 days after CSJ137 is administered ]
  to determine the minimum dose of CSJ137 that is active for treatment

Current Secondary Outcome:

• Peak concentration (Cmax) of CSJ137 in serum [ 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 ]
  to assess the concentration of CSJ137 in the body over time
• Area under the serum concentration versus time curve (AUC) [ 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 ]
  to assess the concentration of CSJ137 in the body over time

Original Secondary Outcome:

• Peak concentration (Cmax) of CSJ137 in serum [ Time Frame: before CSJ137 is administered, then 0.5 hours and 6 hours after CSJ137 is administered on Day 1. Also 2, 3, 4, 6, 13, 20, 29, and 85 days after CSJ137 is administered ]
  to assess the concentration of CSJ137 in the body over time
• Area under the serum concentration versus time curve (AUC) [ Time Frame: before CSJ137 is administered, then 0.5 hours and 6 hours after CSJ137 is administered on Day 1. Also 2, 3, 4, 6, 13, 20, 29, and 85 days after CSJ137 is administered ]
  to assess the concentration of CSJ137 in the body over time

Information By: Novartis

Dates:
Date Received: September 29, 2015
Date Started: September 22, 2015
Date Completion: August 18, 2018
Last Updated: May 10, 2017
Last Verified: May 2017