Phase 2
N=195
A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease
Uncontrolled Hypertension · Chronic Kidney Diseases
Bottom Line
View on ClinicalTrials.gov: NCT05432167 ↗Enrolled (actual)
195
Serious AEs
7.3%
Results posted
May 2025
Primary outcome: Primary: Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) of Pooled CIN-107 and Placebo — -15.22; -7.15 Millimeters of mercury (mmHg) — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CIN-107 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) of Pooled CIN-107 and Placebo |
-15.22; -7.15 | 0.003 sig |
| SECONDARY Change From Baseline in SBP in CIN-107 Compared to Placebo in Participants Assigned to the High-dose Strategy Group |
-14.37; -7.16 | 0.019 sig |
| SECONDARY Change From Baseline of SBP in CIN-107 Compared to Placebo in Participants Assigned to the Low-dose Strategy Group |
-16.14; -7.16 | 0.004 sig |
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).
Eligibility Criteria
Inclusion Criteria
- Has a mean seated SBP ≥ 140 mmHg.
- Has a prior diagnosis of mild-to-severe CKD.
- Has an elevated UACR.
- Is currently taking an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at the maximum tolerated daily dose.
Exclusion Criteria
- Have a documented diagnosis of type 1 diabetes.
- Are not willing or not able to discontinue a mineralocorticoid receptor antagonist (MRA) or a potassium sparing diuretic as part of an existing antihypertensive regimen.
- Have a single occurrence of mean seated SBP >180 mmHg or DBP >110 mmHg during the Screening Period.
- Has a body mass index (BMI) >50 kg/m^2.
- Has documented bilateral clinically relevant renal artery stenosis of ≥70%.
- Has had dialysis for acute kidney injury/acute renal failure within 12 weeks prior to the Screening Period or has a planned dialysis or kidney transplantation during the course of the study.
- Has known documented chronic heart failure New York Heart Association Class III or Class IV and/or hospitalization for heart failure within 6 months of Screening.
- Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months of Screening.
- Has known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease.
- Has planned any major cardiac surgery during the study or had major cardiac surgery within 6 months of Screening.
- Has had a prior solid organ transplant or cell transplant.
- Has a known hypersensitivity to CIN-107 or drugs of the same class
- Has received immunotherapy for treatment of CKD within 6 months of Screening.
- Has any clinically relevant medical or surgical conditions including unstable conditions and/or conditions requiring regular transfusion or treatment with systemic immunosuppressants, including corticosteroids.
- Serum potassium 5.0 mEq/L
- Serum sodium 3 × upper limit of normal (ULN); or Total bilirubin >2 × ULN, unless due to Gilbert's syndrome.
- GFR is 75 mL/min/1.73 m2
- Has uncontrolled diabetes with glycosylated hemoglobin >10.5%.
- Is positive for Human immunodeficiency disease (HIV) antibody, hepatitis B surface antigen, or hepatitis C virus Ribonucleic acid (RNA).
- Has typical consumption of >14 alcoholic drinks weekly.
Data sourced from ClinicalTrials.gov (NCT05432167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.