Status:
COMPLETED
Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Proteinuria
Eligibility:
All Genders
19-65 years
Phase:
PHASE1
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
- 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
- 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.
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05314231
Start Date
June 29 2022
End Date
May 31 2023
Last Update
June 29 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Trial Site 2
Anyang-si, Gyeonggi-do, South Korea, 14068
2
Clinical Trial Site 1
Seoul, South Korea, 03080