Managed Access Programs for EXV811, Atrasentan

NCT ID: NCT07319585

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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

Detailed Description

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CEXV811A12004M - Available - Managed Access Program (MAP) Cohort Treatment Plan CEXV811A12004M to provide access to Atrasentan for IgA nephropathy

Conditions

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IgA Nephropathy

Interventions

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Atrasentan

Patients receive atrasentan

Intervention Type DRUG

Other Intervention Names

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EXV811

Eligibility Criteria

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Inclusion Criteria

1. An independent request was received from a licensed physician.
2. 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.
3. The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
4. 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.
5. 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).
6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
7. Managed Access provision is allowed per local laws/regulations.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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

Role: CONTACT

1-888-669-6682

Novartis Pharmaceuticals

Role: CONTACT

+41613241111

Other Identifiers

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CEXV811A12004M

Identifier Type: -

Identifier Source: org_study_id

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