Study of NM8074 in Patients With aHUS With Evidence of Ongoing Thrombotic Microangiopathy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovelMed Therapeutics
About this trial
This is a Phase II, open-label study designed to determine if intravenously administered NM8074 results in remission from TMA in treatment-naïve aHUS patients.
Eligibility criteria
Qualifiers
Patients ≥ 18 years at the time of consent
Patients with evidence of resistant or relapsed complement-mediated aHUS with symptoms of Thrombocytopenia, hemolysis, ongoing Thrombotic Microangiopathy and acute kidney injury.
Evidence of ongoing Thrombotic Microangiopathy which includes Haptoglobin <LLN or undetectable and/or presence of schistocytes
Acute kidney injury (proteinuria/creatinuria > ULN and/or reduced eGFR)
Disqualifiers
History of bone marrow, hematopoietic stem cell, or solid organ transplantation
Treatment with complement blockers
Patients with infections
HUS due to ADAMTS-13 deficiency (<5%)
Trial design
Treatments tested in this trial
- NM8074
Treatment groups
12 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov