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

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AstraZeneca

Status and phase

Active, not recruiting
Phase 2

Conditions

Chronic Kidney Diseases
Uncontrolled Hypertension

Treatments

Drug: Placebo
Drug: CIN-107

Study type

Interventional

Funder types

Industry

Identifiers

NCT05432167
D6972C00001 (Other Identifier)
CIN-107-123

Details and patient eligibility

About

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).

Full 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.

Enrollment

194 patients

Sex

All

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

194 participants in 3 patient groups, including a placebo group

Low dose CIN-107
Experimental group
Description:
Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks.
Treatment:
Drug: CIN-107
High dose CIN-107
Experimental group
Description:
Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks.
Treatment:
Drug: CIN-107
Placebo
Placebo Comparator group
Description:
Patients will take oral tablets of Placebo for 26 weeks. The dose strength may be titrated within 6 weeks.
Treatment:
Drug: Placebo

Trial contacts and locations

71

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Central trial contact

AstraZeneca Clinical Study Information Center

Data sourced from clinicaltrials.gov

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