CIN-107 for High Blood Pressure in Chronic Kidney Disease
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.12345
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.12467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
3
Treatment groups
Experimental Treatment
Placebo Group
Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks.
Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks.
Patients will take oral tablets of Placebo for 26 weeks. The dose strength may be titrated within 6 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
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
Parexel
Industry Sponsor
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
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.
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-ckdBaxdrostat 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 ...
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.
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.aspxResults 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 ...
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.
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