What side effects are associated with this type of intervention?

Common treatments for high blood pressure include aldosterone receptor antagonists (ARAs) like spironolactone and eplerenone, which can cause hyperkalemia, gynecomastia, and potential feminization of male fetuses. ACE inhibitors and ARBs may lead to hyperkalemia, cough, and angioedema. Calcium channel blockers can cause peripheral edema and constipation. Thiazide diuretics are associated with electrolyte imbalances like hyponatremia and hypokalemia, as well as hyperuricemia. Beta blockers may result in fatigue, bradycardia, and sexual dysfunction. These side effects should be carefully considered when selecting a treatment plan.

What prior FDA approvals exist?

FDA-approved treatments for high blood pressure that are similar to CIN-107 include eplerenone, a selective aldosterone blocker, and LCI699, an aldosterone synthase inhibitor. Eplerenone has been shown to be effective in treating mild-to-moderate hypertension by specifically targeting aldosterone receptors. LCI699, although still under investigation, has demonstrated efficacy in lowering blood pressure by inhibiting aldosterone synthesis. These treatments highlight the therapeutic potential of targeting aldosterone pathways in managing hypertension.

What other types of research exist?

Promising novel alternatives to CIN-107 for high blood pressure treatment in 2024 include: 1) LCI699, another aldosterone synthase inhibitor shown to be effective in clinical trials. 2) Novel mineralocorticoid receptor antagonists with fewer side effects. 3) Aminopeptidase A inhibitors, which have central effects on vasopressin. 4) Combined endothelin A and B receptor blockers. 5) Sacubitril/valsartan, which may be reconsidered for hypertension treatment.

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CIN-107 for High Blood Pressure in Chronic Kidney Disease

Phase 2

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is currently taking an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at the maximum tolerated daily dose.

Is currently taking an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at the maximum tolerated daily dose

Must not have

Has documented bilateral clinically relevant renal artery stenosis of ≥70%

Has had a prior solid organ transplant or cell transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 26

Summary

This trial is testing a new medication called CIN-107 to see if it can help lower blood pressure in patients whose high blood pressure isn't controlled by current treatments and who also have kidney disease. The medication likely works by helping blood flow more easily or reducing body fluid.

Who is the study for?

This trial is for adults with uncontrolled high blood pressure and mild-to-severe chronic kidney disease who are already taking the maximum tolerated dose of ACEi or ARB medications. People with type 1 diabetes, recent major heart issues, certain unstable conditions, extreme lab values, a BMI over 50, severe renal artery stenosis, known allergies to CIN-107 or similar drugs, recent immunotherapy for CKD, positive HIV/hepatitis tests or excessive alcohol intake cannot participate.

What is being tested?

The study is testing the effectiveness and safety of a medication called CIN-107 in treating high blood pressure among patients with chronic kidney disease. Participants will either receive CIN-107 or a placebo (a substance with no therapeutic effect) to compare outcomes between the two groups.

What are the potential side effects?

While specific side effects of CIN-107 are not listed here, common side effects from hypertension medications may include dizziness due to lowered blood pressure, headaches, fatigue and potential electrolyte imbalances which could affect organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on the highest dose I can handle of ACEi or ARB medication.

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I am on the highest dose I can handle of ACEi or ARB medication.

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I have been diagnosed with chronic kidney disease.

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I have been diagnosed with chronic kidney disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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Both of my kidneys' main arteries are significantly narrowed.

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I have had a solid organ or cell transplant in the past.

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I cannot or will not stop taking my current blood pressure medication that saves potassium.

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I have a health condition that needs regular treatment or affects my stability.

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My diabetes is not under control, with an HbA1c level over 10.5%.

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I have had dialysis for kidney issues in the last 12 weeks or will need it during the study.

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I have a severe heart valve problem or thickened heart muscle blocking blood flow.

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I have been diagnosed with type 1 diabetes.

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I have had a stroke, heart attack, or heart failure in the last 6 months.

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My kidney function is either very low or above average.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 26 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in mean seated systolic blood pressure (SBP)

Secondary study objectives

Change from baseline in SBP in CIN-107 compared to placebo in patients assigned to the high-dose strategy group

Change from baseline of SBP in CIN-107 compared to placebo in patients assigned to the low-dose strategy group

Side effects data

From 2022 Phase 2 trial • 275 Patients • NCT04519658

Urinary tract infection

Hyperkalaemia

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Safety Population 0.5mg

Safety Population Placebo

Safety Population 1mg

Safety Population 2mg

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Low dose CIN-107Experimental Treatment1 Intervention

Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks.

Group II: High dose CIN-107Experimental Treatment1 Intervention

Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks.

Group III: PlaceboPlacebo Group1 Intervention

Patients will take oral tablets of Placebo for 26 weeks. The dose strength may be titrated within 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CIN-107

2022

Completed Phase 2

~1010

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include ACE inhibitors, ARBs, calcium channel blockers, diuretics, and aldosterone synthase inhibitors. ACE inhibitors and ARBs work by inhibiting the renin-angiotensin-aldosterone system (RAAS), which reduces blood vessel constriction and decreases blood pressure. Calcium channel blockers relax blood vessels by preventing calcium from entering cells of the heart and blood vessel walls. Diuretics help the kidneys remove excess sodium and water, reducing blood volume and pressure. Aldosterone synthase inhibitors, like CIN-107, specifically target the production of aldosterone, a hormone that increases sodium retention and blood pressure. These mechanisms are crucial for managing high blood pressure as they address different pathways that contribute to elevated blood pressure, providing comprehensive control and reducing the risk of cardiovascular events.

Novel antihypertensive agents for resistant hypertension: what does the future hold?Computational and Pharmacogenomic Insights on Hypertension Treatment: Rational Drug Design and Optimization Strategies.Efficacy and safety of LCI699 for hypertension: a meta-analysis of randomized controlled trials and systematic review.