Multi-center, randomized, double-blind, parallel-group, placebo-controlled 24-week study to evaluate efficacy and safety of XXXX in subjects with uncontrolled hypertension and moderate to severe chronic kidney disease
Summary: The study will consist of four periods: screening, single- blind run-in, double-blind treatment and follow-up periods. At the start of the Run-in period of 4 weeks, participants will receive a single-blind XXB750 placebo injection on top of their antecedent AHMs. ABPM will be performed at the end of run-in period and participants whose blood pressure is not under control at the end of the Run-in period despite compliance with study treatment and background AHMs at constant doses (i.e., with mean 24hr SBP ≥135 mmHg) will be randomized in a 1:1 ratio to receive XXXX 120 mg s.c. followed by 240 mg or matching placebo s.c. q4w for 24 weeks.
Summary: The study will consist of four periods: screening, single- blind run-in, double-blind treatment and follow-up periods. At the start of the Run-in period of 4 weeks, participants will receive a single-blind XXB750 placebo injection on top of their antecedent AHMs. ABPM will be performed at the end of run-in period and participants whose blood pressure is not under control at the end of the Run-in period despite compliance with study treatment and background AHMs at constant doses (i.e., with mean 24hr SBP ≥135 mmHg) will be randomized in a 1:1 ratio to receive XXXX 120 mg s.c. followed by 240 mg or matching placebo s.c. q4w for 24 weeks.
Type of study (PIC, Recruiting): Recruiting
Type of study (PIC, Recruiting): Recruiting
Commercial Study - Site Identification form required to be completed, please find Site ID form uploaded to study documents link below.
Commercial Study - Site Identification form required to be completed, please find Site ID form uploaded to study documents link below.
Recruitment Duration: 01/02/2026 - 31/10/2027
Recruitment Duration: 01/02/2026 - 31/10/2027
Practice Activity: See part B and Schedule of Events
Practice Activity: See part B and Schedule of Events
Practice Eligibility Criteria: GP practices within East Midlands
Practice Eligibility Criteria: GP practices within East Midlands
Practice Target: 2 per site
Practice Target: 2 per site
Is this Study Applicable for RSI Scheme?
Is this Study Applicable for RSI Scheme?
Yes, applicable for RSI scheme
Research Costs:
Research Costs:
Commercial research studies follow a national tariff guideline. Click here for more information on the tariff or download the tariff by clicking here
Commercial research studies follow a national tariff guideline. Click here for more information on the tariff or download the tariff by clicking here