Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kira Pharmacenticals (US), LLC.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Meets criteria for SLE per the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria.
Decrease in platelet count to less than (\<)150,000/microliters (mcL).
Abnormal renal function.
Females of childbearing potential with negative pregnancy test and males must agree to practice effective contraception from Screening until 28 days after the End of study (EOS) visit.
Willing and able to provide informed consent.
Evidence of microangiopathic hemolytic anemia
You may not be if
Diagnosis of other TMA syndromes.
A renal biopsy within 7 days of screening that shows exclusively chronic changes of TMA.
Positive Coombs test at the time of TMA diagnosis.
Active or unresolved Neisseria meningitidis infection at screening.
