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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

NCT05432167

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
  • + 41 more on CT.gov