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Unknown

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
Has a prior diagnosis of mild-to-severe CKD.
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 below
Select...
I have been diagnosed with chronic kidney disease.
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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 am on the highest dose I can handle of ACEi or ARB medication.

Timeline

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

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 • NCT04519658
4%
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
4,217 Previous Clinical Trials
289,739,798 Total Patients Enrolled
CinCor Pharma, Inc.Lead Sponsor
11 Previous Clinical Trials
913 Total Patients Enrolled
ParexelIndustry Sponsor
300 Previous Clinical Trials
99,849 Total Patients Enrolled

Media Library

CIN-107 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05432167 — Phase 2
High Blood Pressure Research Study Groups: Placebo, Low dose CIN-107, High dose CIN-107
High Blood Pressure Clinical Trial 2023: CIN-107 Highlights & Side Effects. Trial Name: NCT05432167 — Phase 2
CIN-107 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05432167 — Phase 2

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 26
CinCor Site 117
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~0 spots leftby Mar 2024