Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)

Summary

The purpose of the study is to assess efficacy, safety and tolerability of treatment with zibotentan and dapagliflozin in combination and dapagliflozin 10 mg as monotherapy in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m\^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and ≤ 5000 mg/g.

Timeline

Start

2021-04-28

Primary completion

2023-06-01

Completion

2023-06-01

Publications

• Smeijer JD, Wasehuus VS, Dhaun N, Gorriz JL, Soler MJ, Astrand M, Mercier AK, Greasley PJ, Ambery P, Heerspink HJL. Effects of Zibotentan Alone and in Combination with Dapagliflozin on Fluid Retention in Patients with CKD. J Am Soc Nephrol. 2024 Oct 1;35(10):1381-1390. doi: 10.1681/ASN.0000000000000436. Epub 2024 Jul 12.
• Heerspink HJL, Kiyosue A, Wheeler DC, Lin M, Wijkmark E, Carlson G, Mercier AK, Astrand M, Ueckert S, Greasley PJ, Ambery P. Zibotentan in combination with dapagliflozin compared with dapagliflozin in patients with chronic kidney disease (ZENITH-CKD): a multicentre, randomised, active-controlled, phase 2b, clinical trial. Lancet. 2023 Nov 25;402(10416):2004-2017. doi: 10.1016/S0140-6736(23)02230-4. Epub 2023 Nov 3.
• Heerspink HJL, Greasley PJ, Ahlstrom C, Althage M, Dwyer JP, Law G, Wijkmark E, Lin M, Mercier AK, Sunnaker M, Turton M, Wheeler DC, Ambery P. Efficacy and safety of zibotentan and dapagliflozin in patients with chronic kidney disease: study design and baseline characteristics of the ZENITH-CKD trial. Nephrol Dial Transplant. 2024 Feb 28;39(3):414-425. doi: 10.1093/ndt/gfad183.
• Smeijer JD, Kohan DE, Webb DJ, Dhaun N, Heerspink HJL. Endothelin receptor antagonists for the treatment of diabetic and nondiabetic chronic kidney disease. Curr Opin Nephrol Hypertens. 2021 Jul 1;30(4):456-465. doi: 10.1097/MNH.0000000000000716.

Drugs

Indications