Recombinant Human C1 Esterase Inhibitor in the Prevention of Contrast-induced Nephropathy in High-risk Subjects
Status:
Completed
Trial end date:
2018-07-01
Target enrollment:
Participant gender:
Summary
Iodinated contrast media have been causally linked to acute kidney injury known as
contrast-induced nephropathy (CIN), which is the consequence of CM-induced local renal
ischemia and direct toxic effects. Conestat alfa (recombinant human C1 esterase inhibitor)
has been shown to decrease renal ischemic damage in experimental models of renal ischemia.
The Recombinant Human C1 Esterase Inhibitor in the Prevention of Contrast-induced Nephropathy
in High-risk Subjects (PROTECT) Study is a randomized, placebo-controlled, double-blind
single-center trial that will assess the effect of prophylactic administration of Conestat
alfa on the degree of acute kidney injury subjects undergoing elective coronary angiography.
Patient with an estimated glomerular filtration rate <=50 ml/min/1.73 m2 and at least one
additional risk factor for CIN will be enrolled and randomly assigned to 1) Conestat alfa at
50 U/kg given as intravenous injection immediately before and 4 hours after coronary
angiography or 2) placebo (sodium chloride). All patients will receive standard intravenous
hydration with isotonic saline. Surrogate markers of kidney injury will be assessed over a 48
hours time period. Patients will be followed for cardiovascular and renal events over 12
weeks.
The primary outcome measure is peak change in urinary Neutrophil gelatinase-associated
lipocalin within 48 hours after elective coronary angiography.
Phase:
Phase 2
Details
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborators:
Clinical Trial Unit, University Hospital Basel, Switzerland Pharming Technologies B.V.
Treatments:
Complement C1 Inactivator Proteins Complement C1 Inhibitor Protein Complement C1s