drugset / Trial / NCT04573920
Atrasentan in Patients With Proteinuric Glomerular Diseases
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function.
Timeline
- Start
- 2021-03-15
- Primary completion
- 2024-07-02
- Completion
- 2026-10-27
Publications
- Kuo JJ, Wu J, Gunawan MG, McConnell MT, Lester J, Naidu NA, Nieh CH, Surendradoss J, Kano T, Suzuki Y, Olson NE, Cox JH. Effects of Atrasentan on Kidney Gene Transcription, Mesangial Cell Proliferation, and Proteinuria in IgA Nephropathy. Kidney360. 2026 May 1;7(5):1003-1016. doi: 10.34067/KID.0000001000. Epub 2025 Dec 24.
- Rheault MN. Treatment Approaches for Alport Syndrome. J Am Soc Nephrol. 2026 Jan 1;37(1):172-179. doi: 10.1681/ASN.0000000897. Epub 2025 Sep 12.
- Lin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available.
- Obadina M, Wilson S, Derebail VK, Little J. Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations. Kidney360. 2023 Jul 1;4(7):997-1005. doi: 10.34067/KID.0000000000000162. Epub 2023 May 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atrasentan | Other / unclassified | 0.75 mg | Oral |
| Subject | Atrasentan | Other / unclassified | 1.5 mg | Oral |