CIN-107 for High Blood Pressure in Chronic Kidney Disease

Recruiting at 153 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

195 Participants Needed

Trial Summary

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 CIN-107 safe for humans?

There is no specific safety data available for CIN-107, but similar treatments like candesartan cilexetil, used for high blood pressure, have been shown to be safe and well-tolerated in humans. ^{1 2 3 4 5}

How does the drug CIN-107 differ from other treatments for high blood pressure in chronic kidney disease?

CIN-107 is unique because it is being specifically studied for its effects on high blood pressure in patients with chronic kidney disease, whereas other treatments like cilnidipine, a calcium channel blocker, are known for their reno-protective actions and blood pressure reduction but are not specifically tailored for this condition. Additionally, CIN-107's mechanism of action or specific benefits compared to existing treatments are not detailed in the provided research, making it a novel option under investigation. ^{1 4 6 7 8}

What is the purpose of this trial?

This trial is testing a new medication called CIN-107 to see if it can help lower blood pressure in patients whose high blood pressure isn't controlled by current treatments and who also have kidney disease. The medication likely works by helping blood flow more easily or reducing body fluid.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and tolerability of high-dose angiotensin receptor blocker therapy in patients with chronic kidney disease: a pilot study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The efficacy and tolerability of candesartan cilexetil in an elderly hypertensive population. [2013]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of preclinical safety profile of SPH3127, a direct renin inhibitor, after 28-day repeated oral administration in Sprague-Dawley rats and cynomolgus monkeys. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of candesartan cilexetil in patients with systemic hypertension. Candesartan Cilexetil Study Investigators. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Preserving Target-organ Function with Candesartan Cilexetil in Patients with Hypertension. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Blood Pressure Reducing Potential and Renoprotective Action of Cilnidipine Among Hypertensive Patients Suffering From Chronic Kidney Disease: A Meta-Analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Renal Function in Hypertensive Patients Receiving Cilnidipine and L-Type Calcium Channel Blockers: A Meta-Analysis of Randomized Controlled and Retrospective Studies. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Renoprotective effects of antihypertensive drugs. [2019]