Clinical trial NCT05314231: Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria
Official title: A Phase 1b, Open-Label, Single-Dose Pharmacokinetic Study of Subcutaneous ALXN1720 in Adult Participants With Varying Degrees of Proteinuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Proteinuria
Keywords: Proteinuria
Glomerular Disease
Chronic Kidney Disease
Lupus Nephritis
Immunoglobulin A Nephropathy
Primary Membranous Nephropathy
Focal Segmental Glomerulosclerosis
Diabetic Nephropathy
Hypertensive Nephrosclerosis
Minimal Change Disease
Thin Basement Membrane Nephropathy
Membranoproliferative Glomerulonephritis (all forms)
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-06
Enrollment: 13
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the impact of proteinuria on the pharmacokinetic (PK) of a single dose of ALXN1720 in participants with proteinuria.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of Lupus Nephritis, IgA Nephropathy, Primary Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Diabetic Nephropathy, Hypertensive Nephrosclerosis, Minimal Change Disease, Thin Basement Membrane Nephropathy or Membranoproliferative Glomerulonephritis (all forms). Other cause of kidney disease may be included per investigator agreement with the Sponsor
* Proteinuria \>=1 based on absolute amount in grams per day (g/d) as measured in one complete and valid 24-hour urine collection during Screening
* Body weight ≥ 40 kg at Screening

Exclusion Criteria:

* Kidney transplant
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 during Screening
* Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
* Treatment with complement inhibitors at any time.
* Treatment with rituximab within 6 months before initiation of study drug on Day 1; or, planned treatment with rituximab within 3 months after initiation of study drug on Day 1.
* Participation in another investigational drug or investigational device study within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.

Primary outcomes:
measure: Serum Concentration of ALXN1720
timeFrame: Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events
timeFrame: Day 1 (Predose) through Follow-up (Day 92)
measure: Serum Concentration of Free and Total Complement Component 5 (C5)
timeFrame: Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57
measure: Number of Participants With Antidrug Antibodies (ADAs) to ALXN1720
timeFrame: Day 1 (predose) through Day 57
Other outcomes:
Locations:
city: Anyang-Si
country: Korea, Republic of
facility: Clinical Trial Site 2
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Site 1
Study officials:
References: