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Also known as AZD2373-Arm 1, AZD2373-Arm 2, AZD2373 subcutaneous injection
AZD2373 · 1 trial · 1 indication
To assess the effect of AZD2373 versus placebo in reducing albuminuria
| Arm | Type | Description |
|---|---|---|
| Part A - Placebo group | PLACEBO_COMPARATOR | Participants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose. |
| Part A - AZD2373 - Arm 1 | EXPERIMENTAL | Participants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose. |
| Part A - AZD2373 - Arm 2 | EXPERIMENTAL | Participants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose. |
| Part B - AZD2373 Arm 1 | EXPERIMENTAL | Participants will be randomized at a 4:1 ratio to 2 study treatment arms. Participants will receive SC injection of the assigned dose |
| Part B - Placebo group | PLACEBO_COMPARATOR | Participants will be randomized at a 4:1 ratio to 2 study treatment arms. Participants will receive SC injection of the assigned dose |
| Name | Type | Description |
|---|---|---|
| AZD2373-Arm 1 | COMBINATION_PRODUCT | Accessorized Pre-Filled Syringe (Solution for injection) |
| AZD2373-Arm 2 | COMBINATION_PRODUCT | Accessorized Pre-Filled Syringe (Solution for injection) |
| Placebo | COMBINATION_PRODUCT | Accessorized Pre-Filled Syringe (Solution for injection). |
| APOL1 Genotyping Clinical Trial Assay | DEVICE | The APOL1 Genotyping Clinical Trial Assay, an investigational use only qualitative Polymerase Chain Reaction invitro diagnostic assay, discriminates between the rs73885319 G1(S342G) and rs71785313 G2 genotypes within the APOL1 gene from DNA extracted from whole blood. |
Inclusion Criteria: * Age: Male and female participants of African descent (including, but not limited to, Black, Black African, Black Caribbean, African American, Afro-Caribbean, Afro-Latino, West African, Mixed Black backgrounds, or other self-identified African diaspora heritage) aged 18 to 70 y...
AZD2373 is an investigational RNA therapy being developed by AstraZeneca for APOL1-mediated kidney disease, a nephrology condition. It is currently in Phase 2 clinical development and has not been approved by the FDA. The program is designed to address kidney disease linked to variants in the APOL1 gene.
AZD2373 is being studied for the treatment of APOL1-mediated kidney disease, a form of kidney injury associated with variants in the APOL1 gene. It is an investigational therapy in Phase 2 testing and is not approved for any indication. Its safety, tolerability, and efficacy are still being evaluated in clinical trials.
AZD2373 targets APOL1, the gene and protein associated with APOL1-mediated kidney disease. As an RNA therapy, it is designed to act on APOL1 rather than on downstream kidney injury pathways. Targeting APOL1 directly is the mechanistic rationale behind its development for this nephrology indication.
AZD2373 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is running the clinical program for the drug in APOL1-mediated kidney disease, a nephrology indication. The asset is an RNA therapy directed at the APOL1 target.
AZD2373 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for APOL1-mediated kidney disease or any other indication. The ongoing Phase 2 study is evaluating its safety, tolerability, and efficacy in participants with this kidney condition.
AZD2373 is being studied in one active Phase 2 trial, NCT06824987, titled a dose-ranging safety, tolerability, and efficacy study in participants with APOL1-mediated kidney disease. The trial is randomized, double-blind, and placebo-controlled, has enrolled 63 participants, and is active but not recruiting. It is running in the United States and the United Kingdom.
Yes. AZD2373-Arm 1, AZD2373-Arm 2, and AZD2373 subcutaneous injection are alternative names used for AZD2373, the AstraZeneca RNA therapy in Phase 2 development for APOL1-mediated kidney disease. These names refer to the same investigational asset and its dosing arms within the clinical program.