Primary AldosteronismPhase 2NCT04605549
A Study of CIN-107 in Adults With Primary Aldosteronism
A Phase 2 study testing CIN-107 2 mg dosing, CIN-107 4 mg dosing and CIN-107 8 mg dosing in people with Primary Aldosteronism and Hyperaldosteronism, run by AstraZeneca at 10 sites in United States.
Trial summary
This is a multicenter, open-label study in adult patients with PA to evaluate the effectiveness and safety of CIN-107 after up to 12 weeks of treatment (Part 1), and then for eligible, consenting patients follow patients in Part 2 for up to 74 weeks for evidence of long-term safety and tolerability. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Primary Aldosteronism, Hyperaldosteronism
- What is being tested?
- CIN-107 2 mg dosing, CIN-107 4 mg dosing and CIN-107 8 mg dosing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 10 sitesUnited States
- Study dates
- 8 Mar 2021to 28 Oct 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Are willing and able to cease dosing of MRA for up to 4 weeks in patients taking MRA.
- Are willing to be compliant with the contraception and reproduction restrictions of the study.
- Have increased SBP by ≥ 20 mmHg or have SBP ≥ 160 mmHg after dosing of MRA treatment is ceased for up to 4 weeks duration, or have SBP ≥ 150 mmHg for patients who are newly diagnosed with PA and have not taken an MRA in the past 12 weeks.
Who cannot join
- At Screening Visit, have a single occurrence of mean seated SBP > 180 mmHg or DBP > 110 mmHg if not taking an MRA; or have a mean seated SBP ≥ 160 mmHg or DBP ≥ 100 mmHg if currently taking an MRA.
- Have a body mass index > 45 kg/m2.
- Have had a previous surgical intervention for an adrenal adenoma or have a planned adrenal carcinoma, adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.
- Have a documented estimated glomerular filtration rate < 45 mL/min/1.73 m2.
- Have a planned dialysis, kidney transplantation or any major surgical procedure during the course of the study.
- Have known documented New York Heart Association class III or IV chronic heart failure.
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- Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before the Screening Visit.
- Have known current severe left ventricular outflow obstruction.
- Have had major cardiac surgery within 6 months before the Screening Visit.
- Have a history of, or currently experiencing, clinically significant arrhythmias.
- Have had a prior solid organ transplant or cell transplant.
- Are positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen.
- Have typical consumption of > 14 alcoholic drinks weekly.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Baltimore, Maryland, 21287
Research Site
Chicago, Illinois, 60611
Research Site
Cincinnati, Ohio, 45245
Research Site
Columbus, Ohio, 43210
Research Site
Dallas, Texas, 75390-9047
Research Site
Greenbrae, California, 94904
Research Site
Rochester, Minnesota, 55905
Research Site
San Francisco, California, 94110
Research Site
West Hollywood, California, 90048
About this study
Official title: A Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Effectiveness of CIN-107 for the Management of Blood Pressure in Patients With Primary Aldosteronism
This is a multicenter, open-label study in adult patients with PA to evaluate the effectiveness and safety of CIN-107 after up to 12 weeks of treatment (Part 1), and then for eligible, consenting patients follow patients in Part 2 for up to 74 weeks for evidence of long-term safety and tolerability.
Read the detailed description
For patients in Part 1 only :
The treatment duration for patients who complete all 3 dose levels, and who opt not to continue in the extension part of the study, is 12 weeks. For patients who do not complete up-titration, the treatment duration will include at least 4 weeks of dosing with the final dose level. If down-titration of CIN-107 dose is determined at Visit 6 (Week 9), the total treatment duration may be extended to 13 weeks to allow sufficient time for CIN-107 treatment effect at the final dose to be assessed. If the final dose of CIN-107 is reached before week 8 (Visit 5) and no up-titration occurs at Visit 5, the patients will be encouraged to continue CIN-107 treatment till Visit 7 for a total of 12 weeks of treatment. The patients who opt not to continue to Part 2 will not receive any study drug and will return for their safety follow up visit (Visit 8) in 2 weeks.
For patients who opt to continue in the extension part (Part 2) of the study:
Patients will continue to receive their dose of baxdrostat and be instructed to measure BP at least once every week prior to dosing with CIN-107 in the morning, during the extension phase. Safety surveillance will be conducted if clinically indicated. Repeat and unscheduled testing for serum potassium may be measured at the investigator's clinical site or at local laboratory for a faster turn-around time to allow clinical assessment. These patients entering part 2 will skip Visit 8 and their next visit will be Visit 9.
- Conditions
- Primary Aldosteronism, Hyperaldosteronism
- Being tested
- CIN-107 2 mg dosing, CIN-107 4 mg dosing, CIN-107 8 mg dosing
- Keywords
- Primary Aldosteronism
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIN-107 2 mg dosingDrug
One tablet of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 2 mg.
CIN-107 4 mg dosingDrug
Two tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 4 mg.
CIN-107 8 mg dosingDrug
Four tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 8 mg.
| Study group | Role | What they receive |
|---|---|---|
| CIN-107 for dosing at 2, 4, or 8 mg (QD) | Experimental | 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. Receives: Drug: CIN-107 2 mg dosing; Drug: CIN-107 4 mg dosing; Drug: CIN-107 8 mg dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Emergent Adverse Events
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Adverse events were collected from the beginning of the study until Week 74. Treatment emergent AEs are defined as AEs that newly occur or worsen in severity during the treatment period.
Measured: 74 weeks
Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) in Patients With Primary Aldosteronism
The mean seated SBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean seated SBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
Measured: 12 weeks
Secondary outcomes (4)
Change From Baseline in Mean Diastolic Blood Pressure (DBP) in Patients With Primary Aldosteronism
The mean DBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean DBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
Measured: 12 weeks
The Percentage of Patients Achieving a Seated BP Response of <140/90 mmHg
The percentage of patients achieving a mean seated SBP <140 mmHg and a mean DBP of <90 mmHg after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
Measured: 12 weeks
The Percentage of Patients Achieving a Seated BP Response of <130/80 mmHg
The percentage of patients achieving a mean seated SBP <130 mmHg and a mean DBP of <80 mmHg after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
Measured: 12 weeks
The Percentage of Patients Achieving the Pharmacodynamic Marker Response
Pharmacodynamic marker response is defined as achieving either: - a plasma aldosterone concentration (PAC) < 15 ng/dL and a plasma renin activity (PRA) ≥ 0.5 ng/mL/h; or - an ARR < 15; or - unsuppressed renin activity PRA ≥ 1.0 ng/mL/h
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start8 Mar 2021
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605549
- Sponsor's protocol ID
- CIN-107-122
- Other IDs
- D6970C00001
- Status last verified
- Feb 2026
- First submitted
- 22 Oct 2020
- Last updated
- 3 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Publications
Townsend RR. Blocking Aldosterone Synthesis: Whose BrigHTN Idea Was That? Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1631-1633. doi: 10.2215/CJN.0000000000000265. Epub 2023 Jul 24. No abstract available.
PubMed 37490693