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A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease
A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease
CompletedPhase 2
Sponsor: AstraZeneca
Conditions: Uncontrolled Hypertension, Chronic Kidney Diseases
Interventions: CIN-107, Placebo
Countries: United States
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 overview
Sex: ALL
Age: 18 Years to 130 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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 \<3.5 mEq/L or \>5.0 mEq/L * Serum sodium \<135 mEq/L * Serum aspartate aminotransferase or alanine aminotransferase \>3 × upper limit of normal (ULN); or Total bilirubin \>2 × ULN, unless due to Gilbert's syndrome. * GFR is \< 25 or \> 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.
Locations (71)
- Birmingham, Alabama, United States
- Huntsville, Alabama, United States
- Beverly Hills, California, United States
- Chula Vista, California, United States
- Fountain Valley, California, United States
- Granada Hills, California, United States
- Lancaster, California, United States
- Lincoln, California, United States
- Los Angeles, California, United States
- Lynwood, California, United States
- Northridge, California, United States
- Panorama City, California, United States
- Pomona, California, United States
- Rancho Cucamonga, California, United States
- Riverside, California, United States
- San Dimas, California, United States
- South Gate, California, United States
- Tarzana, California, United States
- Vacaville, California, United States
- Victorville, California, United States
- Arvada, Colorado, United States
- Littleton, Colorado, United States
- Hollywood, Florida, United States
- Orlando, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Columbus, Georgia, United States
- Decatur, Georgia, United States
- Nampa, Idaho, United States
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