Recombinant Human C1 Esterase Inhibitor in the Prevention of Contrast-induced Nephropathy in High-risk Subjects

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

May 31, 2018

Study Completion Date

July 31, 2018

Conditions
Acute Kidney Injury
Interventions
DRUG

Conestat alfa

Two intravenous injections (over 5 minutes) of Conestat alfa immediately pre-procedure (elective coronary angiography) and 4 hours later; for patients less than 84kg at a dose of 50 U/kg, and for patients of 84kg body weight or greater at a dose of 4200 U.

DRUG

Sodium chloride 0.9%

Two intravenous injections of sodium chloride 0.9% (maximum 28 ml, matching the respective amount of the Conestat alfa arm) immediately pre-procedure (elective coronary angiography) and 4 hours later.

Trial Locations (1)

4031

University Hospital Basel, Basel

Sponsors
All Listed Sponsors
collaborator

Pharming Technologies B.V.

INDUSTRY

collaborator

Clinical Trial Unit, University Hospital Basel, Switzerland

OTHER

lead

University Hospital, Basel, Switzerland

OTHER