drugset / Trial / NCT03574363
Phase 2b Study of KBP-5074 in Subjects With Uncontrolled Hypertension and Advanced Chronic Kidney Disease
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a Phase 2 randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy, safety, and pharmacokinetics of KBP-5074 in patients with moderate-to-severe chronic kidney disease and uncontrolled hypertension.
Timeline
- Start
- 2018-04-25
- Primary completion
- 2020-08-05
- Completion
- 2020-08-05
Outcome
Met primary endpoint
release “The BLOCK-CKD trial met its primary endpoint with ocedurenone demonstrating a clinically meaningful and statistically significant improvement” novonordisk.com ↗
Publications
- Bakris G, Pergola PE, Delgado B, Genov D, Doliashvili T, Vo N, Yang YF, McCabe J, Benn V, Pitt B; BLOCK-CKD Study Group. Effect of KBP-5074 on Blood Pressure in Advanced Chronic Kidney Disease: Results of the BLOCK-CKD Study. Hypertension. 2021 Jul;78(1):74-81. doi: 10.1161/HYPERTENSIONAHA.121.17073. Epub 2021 May 10.
- Bakris G, Yang YF, Pitt B. Mineralocorticoid Receptor Antagonists for Hypertension Management in Advanced Chronic Kidney Disease: BLOCK-CKD Trial. Hypertension. 2020 Jul;76(1):144-149. doi: 10.1161/HYPERTENSIONAHA.120.15199. Epub 2020 Jun 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ocedurenone | Small molecule | 0.25 mg | Oral |
| Subject | Ocedurenone | Small molecule | 0.5 mg | Oral |