Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus

Launched by KIRA PHARMACENTICALS (US), LLC. · Aug 15, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called KP104 for people with a serious condition related to systemic lupus erythematosus (SLE), known as thrombotic microangiopathy (TMA). This study aims to understand how safe and effective KP104 is when used alongside standard treatments for SLE-TMA. The trial has two parts: the first part will focus on finding the best dose of KP104, and the second part will test if it works well in treating the condition.

To participate, individuals should be diagnosed with SLE, have low platelet counts, and show signs of kidney issues or specific blood problems. They must also be willing to follow guidelines for pregnancy prevention. The study is currently not recruiting participants, but it will include individuals aged between 6 and 74 years, regardless of gender. Those who join will receive KP104 along with their usual treatment and will be closely monitored for safety and effectiveness throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.
• • Only key inclusion and exclusion criteria have been included.