PHASE 2 STUDY OF ALXN2050 IN PROLIFERATIVE LUPUS NEPHRITIS (LN) OR IMMUNOGLOBULIN A NEPHROPATHY (IgAN)
- Conditions
- 080 Glomerular disorders in infectious and parasitic diseases classified elsewhereGlomerular disorders in infectious and parasitic diseases classified elsewhereN080
- Registration Number
- PER-040-22
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Without startig enrollment
- Sex
- All
- Target Recruitment
- 0
Male or female participant
Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance
Capable of giving informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Participant must be = 18 and = 75 years of age at the time of signing the informed consent
Vaccinated against meningococcal infection (Neisseria meningitidis) within 3 years prior to, or at the time of randomization. Participants who initiate study intervention < 2 weeks after receiving a meningococcal vaccine must receive appropriate prophylactic antibiotics until at least 2 weeks after the vaccination
Local pathology report from the kidney biopsy used for eligibility must be available
Evidence of human immunodeficiency virus (HIV antibody positive) infection at Screening
Bone marrow insufficiency with absolute neutrophil count < 1.3 × 103/µL; thrombocytopenia (platelet count < 50,000/mm3)
Active systemic bacterial, viral, or fungal infection within 14 days prior to first dose of study intervention
Presence of fever as documented by a temperature = 38°C (100.4°F) within 7 days prior to administration of study intervention on Day 1
History of N meningitidis infection
Estimated GFR = 30 mL/min/1.73 m2 during Screening calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
More than or equal to 50% interstitial fibrosis, tubular atrophy, glomerular sclerosis, or crescent formation in glomeruli on most recent kidney biopsy prior or during the Screening Period
Concomitant significant renal disease other than LN or IgAN on the most recent biopsy prior to or during the Screening Period
History of solid organ (kidney, heart, lung, small bowel, pancreas, or liver) or bone marrow transplant, or planned transplant during the blinded Extended Treatment Period (50 weeks)
Splenectomy or functional asplenia
History of seizure
Known or suspected complement deficiency, unless attributable to underlying disease (ie, LN and IgAN)
History or presence of any risk factors for Torsades de Pointes (eg, heart failure/cardiomyopathy or family history of Long QT Syndrome), a screening QT interval corrected using Fridericia's formula (QTcF) > 450 msec for males and > 470 msec for females, or receiving medications known to significantly prolong the corrected QT interval (QTc), except for hydroxychloroquine in patients with LN
Laboratory abnormalities at Screening, including:
• Alanine aminotransferase (ALT) > 2 × the upper limit of normal (ULN)
• Direct bilirubin > 2 × ULN
Hemoglobin A1C at Screening > 7.0%
Any other clinically significant laboratory abnormality that, in the opinion of the Investigator, would make the participant inappr
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Analysis of 24-hour urine<br> NAME OF THE RESULT: Percentage change in proteinuria from baseline to Week 26 (based on 24-hour urine collection[s])<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: Baseline and Week 26
- Secondary Outcome Measures
Name Time Method