Managed Access Programs for EXV811, Atrasentan

NCT07319585 | Unknown

• 1 other identifier: CEXV811A12004M
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this registration is to list Managed Access Programs (MAPs) related to EXV811, Atrasentan

Conditions

IgA Nephropathy

Keywords

MAP; Managed Access Program; IgA Nephropathy; EXV811; Atrasentan

Interventions

Atrasentan DRUG

Patients receive atrasentan

Also known as: EXV811

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An independent request was received from a licensed physician.
• The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
• The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
• There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
• The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
• Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
• Managed Access provision is allowed per local laws/regulations.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Atrasentan

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzodioxoles; Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrrolidines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

MAP requests are initiated by a licensed physician. https// www.novart is.com/healthcare-professionals/managed-acces-programs

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 6, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01