Managed Access Programs for EXV811, Atrasentan

Novartis

Status

Conditions: IgA Nephropathy

Treatments: Drug: Atrasentan

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT07319585

CEXV811A12004M

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.