CIN-107 for High Blood Pressure in Chronic Kidney Disease

No longer recruiting at 155 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Must be taking: ACEi, ARB

Must not be taking: MRA, Potassium sparing diuretics

Disqualifiers: Type 1 diabetes, Heart failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CIN-107 for individuals with high blood pressure and chronic kidney disease. Researchers aim to evaluate the effectiveness and safety of CIN-107 compared to a placebo (a pill with no active medication). Participants will receive either a low or high dose of CIN-107 or a placebo for 26 weeks. Ideal candidates for this trial have chronic kidney problems and high blood pressure, even while on their current medication. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you continue taking an ACE inhibitor or angiotensin receptor blocker at the maximum tolerated dose. However, you must be willing to stop taking a mineralocorticoid receptor antagonist or a potassium-sparing diuretic if you are currently using them.

Is there any evidence suggesting that CIN-107 is likely to be safe for humans?

Research has shown that CIN-107 is generally well-tolerated by patients. In an earlier study, even individuals with kidney failure safely took a single dose of CIN-107, indicating that kidney problems did not significantly affect the drug's processing in the body. Another study found that adding CIN-107 to regular treatment helped control high blood pressure and slow the progression of kidney disease. While these results are promising, CIN-107 is still undergoing testing to ensure its safety and effectiveness at different doses and for various conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for high blood pressure?

Unlike the standard blood pressure medications for chronic kidney disease, which often include ACE inhibitors or ARBs, CIN-107 is unique because it targets the aldosterone synthase enzyme. This approach offers a new mechanism of action by directly reducing excess aldosterone, a hormone that can lead to high blood pressure and worsen kidney function. Researchers are excited about CIN-107 because it has the potential to more precisely control blood pressure with fewer side effects related to hormone imbalances, offering a promising alternative to existing treatments.

What evidence suggests that CIN-107 might be an effective treatment for high blood pressure in chronic kidney disease?

Research has shown that CIN-107, also known as Baxdrostat, may help treat high blood pressure in people with chronic kidney disease (CKD). Studies have found that this medication can lower blood pressure and might slow the progression of kidney disease. CIN-107 blocks an enzyme involved in producing aldosterone, a hormone that can raise blood pressure. Early trials showed that patients taking CIN-107 experienced a noticeable drop in blood pressure. In this trial, participants will receive either a low or high dose of CIN-107, or a placebo. These findings suggest that CIN-107 could be an effective treatment option for people with uncontrolled high blood pressure and CKD. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your average seated blood pressure is higher than 140 mmHg.

You have high levels of protein in your urine.

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

Exclusion Criteria

Your blood pressure was really high when measured while sitting down.

You are allergic to CIN-107 or similar drugs.

You have HIV, hepatitis B, or hepatitis C.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 5 weeks

Double-Blind Treatment

Participants receive either placebo or CIN-107 (low or high dose) for 26 weeks, with dose titration possible within the first 6 weeks

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CIN-107
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Low dose CIN-107 Experimental Treatment 1 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-107 Experimental Treatment 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

CinCor Pharma, Inc.

Lead Sponsor

Trials

12

Recruited

1,100+

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05432167

NCT05432167 | A Study to Evaluate CIN-107 for the ... This randomized, double-blind, placebo-controlled will evaluate the efficacy and safety of CIN-107 in patients with uHTN and CKD.

2. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/CIN-107-123

A Study to Evaluate CIN-107 for the Treatment of Patients ... This randomized, double-blind, placebo-controlled will evaluate the efficacy and safety of CIN-107 in patients with uHTN and CKD.

3. pharmacytimes.com pharmacytimes.com/view/baxdrostat-manages-high-blood-pressure-delays-kidney-disease-progression-in-patients-with-ckd

Baxdrostat Manages High Blood Pressure, Delays Kidney ... Baxdrostat shows promise in managing hypertension and delaying kidney disease progression in CKD patients, as demonstrated in the phase 2 FigHTN ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10103316/

Intensive BP Control in Patients with CKD and Risk for ... They found that overall, intensive BP control was associated with a 13% lower, but not significant, risk of a kidney outcome.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0146280623003353

Baxdrostat: A Novel Aldosterone Synthase Inhibitor for ... Baxdrostat (CIN-107), a highly potent ASI developed by CinCor, has demonstrated promising results in recent trials and is currently undergoing phase 3 trials.

6. journals.lww.com journals.lww.com/jasn/fulltext/2022/11001/results_from_a_phase_1_study_demonstrating_the.1878.aspx

Results From a Phase 1 Study Demonstrating the Safety ... A single dose of CIN-107 was well tolerated in all subjects, including those with kidney failure. Renal impairment did not significantly impact systemic ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06268873

NCT06268873 | A Phase III Study to Investigate the ... The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN.