A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects with IgA Nephropathy on Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) (The ASSIST study)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503828-13-00

Acronym

CEXV811A12201

Enrollment

Registered

2023-10-30

Start date

2023-12-12

Completion date

2025-08-06

Last updated

2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrology

Brief summary

The change in proteinuria (UPCR from a 24-hour urine collection) from Baseline to Week 12

Detailed description

In Treatment Period 2, the change in proteinuria (UPCR from a 24 hour urine collection) from Baseline to Week 24

Interventions

DRUGMatching placebo film-coated round tablets

DRUGatrasentan

DRUGDAPAGLIFLOZIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The change in proteinuria (UPCR from a 24-hour urine collection) from Baseline to Week 12	—

Secondary

Measure	Time frame
In Treatment Period 2, the change in proteinuria (UPCR from a 24 hour urine collection) from Baseline to Week 24	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026