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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 26
Awards & highlights
Study Summary
This trial will test if CIN-107 is effective and safe for treating high blood pressure in patients who have uncontrolled hypertension and Chronic Kidney Disease.
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.Check my eligibility
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.See study design
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 belowSelect...
I am on the highest dose I can handle of ACEi or ARB medication.
Select...
I am on the highest dose I can handle of ACEi or ARB medication.
Select...
I have been diagnosed with chronic kidney disease.
Select...
I have been diagnosed with chronic kidney disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 26
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in mean seated systolic blood pressure (SBP)
Secondary outcome measures
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 • NCT045196584%
Urinary tract infection
3%
Hyperkalaemia
1%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety Population 0.5mg
Safety Population 1mg
Safety Population 2mg
Safety Population Placebo
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
2020
Completed Phase 2
~820
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,592 Total Patients Enrolled
CinCor Pharma, Inc.Lead Sponsor
11 Previous Clinical Trials
913 Total Patients Enrolled
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,632 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.Your average seated blood pressure is higher than 140 mmHg.You have high levels of protein in your urine.Both of my kidneys' main arteries are significantly narrowed.Your blood potassium levels are too low or too high.I have had a solid organ or cell transplant in the past.You regularly drink more than 14 alcoholic drinks per week.I am on the highest dose I can handle of ACEi or ARB medication.I am on the highest dose I can handle of ACEi or ARB medication.My diabetes is not under control, with an HbA1c level over 10.5%.I have been diagnosed with chronic kidney disease.I have a health condition that needs regular treatment or affects my stability.I cannot or will not stop taking my current blood pressure medication that saves potassium.I have had dialysis for kidney issues in the last 12 weeks or will need it during the study.I have not had major heart surgery in the last 6 months and do not plan any during the study.Your blood sodium level is less than 135 mEq/L.I have severe heart failure or was hospitalized for it within the last 6 months.I have a severe heart valve problem or thickened heart muscle blocking blood flow.Your liver blood tests show high levels of certain enzymes or bilirubin, unless it's because of a condition called Gilbert's syndrome.You have high levels of a certain protein in your urine.I have been diagnosed with chronic kidney disease.Your average sitting blood pressure is consistently higher than 140 mmHg.I have been diagnosed with type 1 diabetes.You weigh more than 300 pounds for someone who is 6 feet tall.I have received immunotherapy for CKD within the last 6 months.I have had a stroke, heart attack, or heart failure in the last 6 months.My kidney function is either very low or above average.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Low dose CIN-107
- Group 3: High dose CIN-107
Awards:
This trial has 0 awards, including: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.
Is enrollment currently available for this investigation?
"Affirmative, according to clinicaltrials.gov this medical trial is actively enrolling participants. It was first posted on May 27th 2022 and has recently been updated on November 2nd 2022. 300 individuals are needed to be recruited across 64 sites."
Answered by AI
Has the FDA sanctioned CIN-107 for medicinal use?
"Our team at Power has rated CIN-107 with a score of 2, as the supporting data for its safety is present but efficacy studies have yet to be conducted."
Answered by AI
How many healthcare centers in this urban area are hosting the trial?
"This trial is based at 3 core locations: CinCor Site 23 in Monroe, Louisiana; CinCorp Site 88 in Vacaville, California; and CinCrop Site 42 in Los Angeles, Florida. In addition to those sites, enrolment is also occuring across 64 other medical centres."
Answered by AI
How many individuals are eligible to join this medical research study?
"All signs point to this trial on clinicaltrials.gov being open for recruitment; it was first listed on May 27th 2022 and the listing has been updated most recently at November 2nd 2022. The study is seeking 300 participants across 64 locations in total."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
California
How old are they?
18 - 65
What site did they apply to?
CinCor Site 56
CinCor Site 26
CinCor Site 117
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I am on max dose of 4 meds and still have unacceptably high BP (systolic) readings.
PatientReceived no prior treatments
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