Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06797518
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Glomerulonephritis, IGA
  • Immunoglobulin A Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Iptacopan — DRUG
    LNP023 oral capsule 200 mg b.i.d

Study Details

A study to investigate the impact of iptacopan treatment on the underlying immunopathology in patients with IgAN by assessing changes in key clinical and molecular markers from baseline to 9 months. The study aims to provide insights into the treatment's systemic and kidney-specific aspects by quantifying the change in mesangial C3c containing fragments deposition, as an indicator of complement activation, and evaluating a variety of biomarkers related to kidney function, damage, and disease progression, including but not limited to Oxford MEST-C score.

Key Dates

Start date
Feb 21, 2025
Status verified
Apr 2026
Primary completion
Nov 27, 2027
Completion
Nov 27, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Iptacopan
    All the study participants will receive iptacopan 200 mg oral capsule b.i.d, while remaining on the maximally tolerated or locally approved maximal daily doses of ACEi/ARB throughout the treatment period.

Primary Outcome Measure

Proportion of participants achieving a reduction of minimum one order of magnitude in complement C3c mesangial deposition. [ Time Frame: BSL, Month 9 ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (9)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Ashlee Chatham
[email protected]
+1 205 934 3734
Dana Rizk (PRINCIPAL_INVESTIGATOR)
UCLA Medical CenterLos AngelesCalifornia90095
Jessica Gomez
[email protected]
Mrinalini Sarkar (PRINCIPAL_INVESTIGATOR)
Central Florida Kidney SpecialistsOrlandoFlorida32806
Adreanna Perez
[email protected]
+1 407 816 5700
Arvind Madan (PRINCIPAL_INVESTIGATOR)
Georgia Nephrology Research InstLawrencevilleGeorgia30046
Vivian Luu
[email protected]
+1 404 645 7850#3024
James A Tumlin (PRINCIPAL_INVESTIGATOR)
CaRe ResearchChubbuckIdaho83202
Carolina Saldana
[email protected]
+1 208 904 4780
Hira Siktel (PRINCIPAL_INVESTIGATOR)
DaVita Clinical ResearchLas VegasNevada89146
Farzana Siddiqui
[email protected]
Mark Vishnepolsky (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44106
Tricia Young
[email protected]
+1 216 844 5396
Andrew Lazar (PRINCIPAL_INVESTIGATOR)
OSU Wexner Medical CenterColumbusOhio43210
Laci Roberts
[email protected]
+1 614 293 4098
Isabelle Ayoub (PRINCIPAL_INVESTIGATOR)
Prolato Clinical Research CenterHoustonTexas77054
Meadia Arabzada
[email protected]
+1 832 338 9118
Sreedhar Mandayam (PRINCIPAL_INVESTIGATOR)

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By research site
University of Alabama at Birmingham· Birmingham, ALUCLA Medical Center· Los Angeles, CACentral Florida Kidney Specialists· Orlando, FLGeorgia Nephrology Research Inst· Lawrenceville, GACaRe Research· Chubbuck, IDDaVita Clinical Research· Las Vegas, NV

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