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

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 22, 2015

Primary Completion Date

May 13, 2020

Study Completion Date

May 13, 2020

Conditions
Anemia, Iron-Deficiency
Interventions
BIOLOGICAL

CSJ137

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.

DRUG

Placebo

Subjects will be dosed with a matching placebo (vehicle control) via up to 30 minutes intravenous infusion.

Trial Locations (13)

12808

Novartis Investigative Site, Prague

32809

Novartis Investigative Site, Orlando

37404

Novartis Investigative Site, Chattanooga

38100

Novartis Investigative Site, Hadera

49100

Novartis Investigative Site, Petah Tikva

55404

Novartis Investigative Site, Minneapolis

62439

Novartis Investigative Site, Tel Aviv

78278

Novartis Investigative Site, Ashkelon

80228

Novartis Investigative Site, Lakewood

91120

Novartis Investigative Site, Jerusalem

91942

Novartis Investigative Site, San Diego

Unknown

Novartis Investigative Site, Ramat Gan

SW17 0QT

Novartis Investigative Site, London

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY