NCT05432167

A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of CIN-107 for the treatment of hypertension in patients with uncontrolled hypertension (uHTN) and Chronic Kidney Disease (CKD).

Detailed description

This randomized, double-blind, placebo-controlled will evaluate the efficacy and safety of CIN-107 in patients with uHTN and CKD. Approximately 200 patients will be randomized in a 1:1:1 ratio into 1 of the 3 treatment groups (placebo, low dose treatment strategy and high dose treatment strategy). The study will consist of the following 3 periods: * A Screening Period of up to 5 weeks; * A Double-Blind Treatment Period of 26 weeks; and * A Follow-Up Period of 2 weeks. Patients will complete the study in approximately 8 months.

Conditions

• Uncontrolled Hypertension
• Chronic Kidney Diseases

Interventions

Type	Name	Description
DRUG	CIN-107	Patients will take CIN-107 tablets by mouth once daily.
DRUG	Placebo	Patients will take placebo tablets by mouth once daily.

Timeline

• Start date: 2022-04-29
• Primary completion: 2024-05-02
• Completion: 2024-05-02
• First posted: 2022-06-27
• Last updated: 2025-05-20
• Results posted: 2025-05-20

Locations

71 sites across 1 country: United States

Regulatory

• FDA-regulated drug study