Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.

Part of paid clinical trials in Denver, Colorado.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06858319
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Glomerular Disease
  • Glomerulonephritis
  • Glomerulonephritis, IGA
  • Glomerulopathy
  • Immunoglobulin Disease
  • Kidney Diseases
  • Kidney Diseases, Chronic
  • Urological Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • zigakibart — DRUG
    solution for subcutaneous injection

Study Details

The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study.

Key Dates

Start date
Jul 28, 2025
Status verified
May 2026
Primary completion
Jun 25, 2031
Completion
Jun 25, 2031

Study Design

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

Arms

  • Experimental: zigakibart
    Participants will receive zigakibart.

Primary Outcome Measure

Number of participants with adverse events. [ Time Frame: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment ]

Central Contacts

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

Locations (7)

FacilityCityStateZIPSite coordinators
Colorado Kidney Care NephrologyDenverColorado80230
Laura Kooienga (PRINCIPAL_INVESTIGATOR)
Nephrology Associates Of Central FLOrlandoFlorida32806
Arvind Madan (PRINCIPAL_INVESTIGATOR)
NY NephrologyClifton ParkNew York12065
+1 518 579 0017
Frank Cortazar (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Kristin Meliambro (PRINCIPAL_INVESTIGATOR)
Knoxville Kidney Center PllcBrentwoodTennessee37027-4528
George Newman (PRINCIPAL_INVESTIGATOR)
Dallas Renal GroupDallasTexas75230
Phuong Truong (PRINCIPAL_INVESTIGATOR)
Dallas Renal GroupDallasTexas75230
+1 214 697 7187
Irfan Agha (PRINCIPAL_INVESTIGATOR)

Find similar trials in Denver, CO

By research site
Colorado Kidney Care Nephrology· Denver, CONephrology Associates Of Central FL· Orlando, FLNY Nephrology· Clifton Park, NYIcahn School of Medicine at Mount Sinai· New York, NYKnoxville Kidney Center Pllc· Brentwood, TNDallas Renal Group· Dallas, TX

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