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CIN-107 for Primary Aldosteronism (spark-PA Trial)
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
Have been diagnosed with PA
Are taking mineralocorticoid receptor antagonist (MRA) to control BP; or are newly diagnosed with PA and have not started MRA treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 74 weeks
Awards & highlights
spark-PA Trial Summary
This trial will study the effectiveness and safety of CIN-107, a new medication, in treating adults with primary aldosteronism. Treatment will last for 12 weeks, and patients will be given doses of 2-8 mg per day.
Who is the study for?
Adults with Primary Aldosteronism (PA) can join this trial. They must be willing to stop taking mineralocorticoid receptor antagonists for up to 4 weeks and comply with contraception rules. People are excluded if they have severe heart failure, recent major surgeries, certain infections like HIV or hepatitis, high alcohol intake, extreme obesity, or a history of significant cardiovascular events.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of three different doses of CIN-107 (2 mg, 4 mg, and 8 mg) in treating PA over a period of up to 12 weeks initially. Participants who qualify may continue into Part 2 for long-term assessment lasting up to an additional 74 weeks.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions related to CIN-107 during the initial treatment phase and those continuing into the long-term follow-up.
spark-PA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with pulmonary arterial hypertension (PAH).
Select...
I am taking medication to control my blood pressure, or I have been newly diagnosed with primary aldosteronism and haven't started treatment yet.
spark-PA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 74 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~74 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in mean seated systolic blood pressure (SBP)
To evaluate the safety and tolerability of CIN-107
Secondary outcome measures
Change in mean diastolic blood pressure (DBP)
The percentage of patients achieving a seated BP response <130/80 mmHg
The percentage of patients achieving a seated blood pressure (BP) response <140/90 mmHg
+1 morespark-PA Trial Design
1Treatment groups
Experimental Treatment
Group I: CIN-107 for dosing at 2, 4, or 8 mg (QD)Experimental Treatment3 Interventions
Patients will be provided with an initial dose of CIN-107 and start once daily (QD) dosing of CIN-107 tablets at 2 mg. At Visit 4, CIN-107 dose may be up-titrated to 4 mg QD if the patient has tolerated dosing of CIN-107 at 2 mg and the blood pressure (BP) records indicate minimal hypotension risk.
At Visit 5, CIN-107 dose may be up-titrated to 8 mg QD if the patient has tolerated dosing of CIN-107 at 4 mg.
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,887 Total Patients Enrolled
CinCor Pharma, Inc.Lead Sponsor
11 Previous Clinical Trials
1,092 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had serious heart rhythm problems.You have HIV, hepatitis C, or hepatitis B.My blood pressure is high, above 180/110 without MRA or above 160/100 with MRA.I have had or will have surgery for adrenal gland issues.I am scheduled for a major surgery, dialysis, or kidney transplant during the study.I have a severe blockage in my heart's left ventricle.My kidney function is reduced, with a filtration rate below 45 mL/min.I have been diagnosed with pulmonary arterial hypertension (PAH).My blood pressure increased by 20 mmHg or was over 160 mmHg after stopping MRA treatment, or was over 150 mmHg as a new PA patient without recent MRA use.You have had an organ or cell transplant in the past.I am taking medication to control my blood pressure, or I have been newly diagnosed with primary aldosteronism and haven't started treatment yet.I have severe chronic heart failure.I have not had a stroke, heart attack, or severe heart issues in the last 6 months.I had major heart surgery less than 6 months ago.You drink more than 14 alcoholic drinks every week.My BMI is over 45.I can stop taking my MRA medication for up to 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: CIN-107 for dosing at 2, 4, or 8 mg (QD)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many research locations are currently conducting the trial?
"Patients are being invited to partake in this trial at Houston's CinCor Site 06, Atlanta's 14th CinCor site, and Chicago's 12th location. Additionally, 18 other medical centres across the country are also participating."
Answered by AI
What is the upper limit to the number of people enrolled in this trial?
"This clinical trial requires 18 qualified patients to be recruited from two different sites: CinCor Site 06 in Houston, Texas and CinCor Site 14 in Atlanta, Georgia. In order to participate they must also meet the specified inclusion criteria."
Answered by AI
What level of peril is associated with 8 mg doses of CIN-107?
"The empirical evidence for the safety of CIN-107 8 mg dosing is sufficient to assign it a rating of 2 on our team's scale, as there has been no data in support of efficacy but some backing its security."
Answered by AI
Does this clinical trial offer opportunities for participation to individuals?
"According to the clinicaltrials.gov listing, this medical study is currently in progress and recruitment of candidates is underway. It was originally posted on January 13th 2021 with a recent update occurring on September 5th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
CinCor Site 06
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
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