Randomisierte, doppelblinde, placebokontrollierte Phase 2 Studie zur Beurteilung der Sicherheit und Wirksamkeit einer prophylaktischen Gabe von Conestat alpha in Bezug auf das Auftreten einer Nierenschädigung nach geplanter Herzkatheteruntersuchung

Drug: Conestat alfa;Drug: Sodium chloride 0.9%

Inclusion Criteria:

- Estimated glomerular filtration rate (eGFR) of <50 ml/min/1.73m2

- At least one of the following risk factors: diabetes mellitus, age at least 75 years,
anemia (baseline hematocrit value less or equal 39% for men and less or equal 36% for
women), congestive heart failure class III or IV by New York Heart Association
classification, history of pulmonary edema.

Exclusion Criteria:

- Contraindications to the class of drugs under study (C1 esterase inhibitors), e.g.
known hypersensitivity or allergy to class of drugs or the investigational product

- History of allergy to rabbits

- Current treatment with N-acetylcysteine, sodium bicarbonate, fenoldopam, mannitol (not
applicable to mannitol serving as excipient in other medical drugs), dopamine or
theophylline

- Women who are pregnant or breast feeding

- Multiple myeloma

- Acute decompensated heart failure (requiring hospital admission and treatment with
supplemental oxygen, diuretics and/or vasodilator therapy) within two weeks prior to
the date of coronary angiography

- Acute myocardial infarction (ST elevation or non-ST elevation myocardial infarction)
within two weeks prior to the date of coronary angiography

- Dialysis

- Exposure to iodinated contrast media within seven days prior to the date of coronary
angiography.

- Participation in another study with investigational drug within the 30 days preceding
and during the present study

- Previous enrolment into the current study

- Enrolment of the investigators and their family members