NCT05504187Not yet recruitingPhase 2
Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus
An Open-label, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104 in Subjects With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 28 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of KP104 in participants with systemic lupus erythematosus (SLE)-Thrombotic microangiopathy (TMA). The study consists of 2 parts: Part 1 (Dose Optimization) and Part 2 (Proof of Concept). All participants will receive KP104 in combination with standard of care (SOC) for SLE-TMA.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 15 Aug 2022
- Start date
- Mar 2025
- Primary completion date
- Mar 2026
- Lead sponsor
- Kira Pharmacenticals (US), LLC.
- Diseases
- Lupus (SLE)
- NCT number
- NCT05504187
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 24
- From Mar 2025 to the primary completion date, Mar 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of other TMA syndromes.
- Active or unresolved Neisseria meningitidis infection at screening.
- Only key inclusion and exclusion criteria have been included.
Other
- A renal biopsy within 7 days of screening that shows exclusively chronic changes of TMA.
- Positive Coombs test at the time of TMA diagnosis.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.