Uncontrolled HypertensionPhase 2NCT05432167
A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease
A Phase 2 study testing CIN-107 in people with Uncontrolled Hypertension and Chronic Kidney Diseases, run by AstraZeneca at 71 sites in United States.
Trial summary
This study will evaluate the efficacy and safety of CIN-107 for the treatment of hypertension in patients with uncontrolled hypertension (uHTN) and Chronic Kidney Disease (CKD). Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Uncontrolled Hypertension, Chronic Kidney Diseases
- What is being tested?
- CIN-107
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 71 sitesUnited States
- Study dates
- 29 Apr 2022to 2 May 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Has a mean seated SBP ≥ 140 mmHg.
- Has a prior diagnosis of mild-to-severe CKD.
- Has an elevated UACR.
- Is currently taking an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at the maximum tolerated daily dose.
Who cannot join
- Have a documented diagnosis of type 1 diabetes.
- Are not willing or not able to discontinue a mineralocorticoid receptor antagonist (MRA) or a potassium sparing diuretic as part of an existing antihypertensive regimen.
- Have a single occurrence of mean seated SBP >180 mmHg or DBP >110 mmHg during the Screening Period.
- Has a body mass index (BMI) >50 kg/m^2.
- Has documented bilateral clinically relevant renal artery stenosis of ≥70%.
- Has had dialysis for acute kidney injury/acute renal failure within 12 weeks prior to the Screening Period or has a planned dialysis or kidney transplantation during the course of the study.
Show all 21Show fewer
- Has known documented chronic heart failure New York Heart Association Class III or Class IV and/or hospitalization for heart failure within 6 months of Screening.
- Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months of Screening.
- Has known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease.
- Has planned any major cardiac surgery during the study or had major cardiac surgery within 6 months of Screening.
- Has had a prior solid organ transplant or cell transplant.
- Has a known hypersensitivity to CIN-107 or drugs of the same class
- Has received immunotherapy for treatment of CKD within 6 months of Screening.
- Has any clinically relevant medical or surgical conditions including unstable conditions and/or conditions requiring regular transfusion or treatment with systemic immunosuppressants, including corticosteroids.
- Serum potassium <3.5 mEq/L or >5.0 mEq/L
- Serum sodium <135 mEq/L
- Serum aspartate aminotransferase or alanine aminotransferase >3 × upper limit of normal (ULN); or Total bilirubin >2 × ULN, unless due to Gilbert's syndrome.
- GFR is < 25 or > 75 mL/min/1.73 m2
- Has uncontrolled diabetes with glycosylated hemoglobin >10.5%.
- Is positive for Human immunodeficiency disease (HIV) antibody, hepatitis B surface antigen, or hepatitis C virus Ribonucleic acid (RNA).
- Has typical consumption of >14 alcoholic drinks weekly.
Trial locations and contacts
71 sites in 1 country.
71 sites in 1 country
United States71 sites
Research Site
Alexandria, Virginia, 22304
Research Site
Arvada, Colorado, 80002
Research Site
Bethany, Oklahoma, 73008
Research Site
Beverly Hills, California, 90211
Research Site
Birmingham, Alabama, 35209
Research Site
Brownsburg, Indiana, 46112
Research Site
Burke, Virginia, 22015
Research Site
Burlington, Vermont, 05401
Research Site
Charlottesville, Virginia, 22908
Research Site
Chicago, Illinois, 60643
Research Site
Chula Vista, California, 91910
Research Site
Cincinnati, Ohio, 45246
Research Site
Columbus, Georgia, 31904
Research Site
Decatur, Georgia, 30030
Research Site
Durham, North Carolina, 27704
Research Site
Flint, Michigan, 48504
Research Site
Flint, Michigan, 48532
Research Site
Fountain Valley, California, 92708
Research Site
Granada Hills, California, 91344
Research Site
Greenville, North Carolina, 27834
Research Site
Hollywood, Florida, 33021
Research Site
Houston, Texas, 77099
Research Site
Huntsville, Alabama, 35805
Research Site
Kansas City, Missouri, 64111
Research Site
Kingwood, West Virginia, 26537
Research Site
Kinston, North Carolina, 28504
Research Site
Lampasas, Texas, 76550
Research Site
Lancaster, California, 93534
Research Site
Lexington, Kentucky, 40503
Research Site
Lincoln, California, 95648
Research Site
Littleton, Colorado, 80120
Research Site
Los Angeles, California, 90010
Research Site
Lynwood, California, 90262
Research Site
Manassas, Virginia, 20110
Research Site
Memphis, Tennessee, 38119
Research Site
Metairie, Louisiana, 70006
Research Site
Monroe, Louisiana, 71201
Research Site
Morganton, North Carolina, 28655
Research Site
Nampa, Idaho, 83687
Research Site
New Bedford, Massachusetts, 02740
Research Site
Newport News, Virginia, 23606
Research Site
Northridge, California, 91324
Research Site
Olive Branch, Mississippi, 38654
Research Site
Orlando, Florida, 32807
Research Site
Orlando, Florida, 32808
Research Site
Oxford, North Carolina, 27565
Research Site
Panorama City, California, 91402
Research Site
Paris, Texas, 75462
Research Site
Pomona, California, 91767
Research Site
Providence, Rhode Island, 02903
Research Site
Rancho Cucamonga, California, 91730
Research Site
Red Oak, Texas, 75154
Research Site
Riverside, California, 92503
Research Site
Salem, Virginia, 24153
Research Site
Salt Lake City, Utah, 84132
Research Site
San Antonio, Texas, 78212
Research Site
San Antonio, Texas, 78249
Research Site
San Dimas, California, 91773
Research Site
Scottdale, Pennsylvania, 15683
Research Site
Silver Spring, Maryland, 20904
Research Site
Smithfield, Pennsylvania, 15478
Research Site
South Gate, California, 90280
Research Site
Tampa, Florida, 33612
Research Site
Tarzana, California, 91356
Research Site
The Bronx, New York, 10455
Research Site
Trenton, New Jersey, 08611
Research Site
Troy, Michigan, 48085
Research Site
Vacaville, California, 95687
Research Site
Victorville, California, 92392
Research Site
West Palm Beach, Florida, 33401
Research Site
Wilmington, North Carolina, 28401
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease
This study will evaluate the efficacy and safety of CIN-107 for the treatment of hypertension in patients with uncontrolled hypertension (uHTN) and Chronic Kidney Disease (CKD).
Read the detailed description
This randomized, double-blind, placebo-controlled will evaluate the efficacy and safety of CIN-107 in patients with uHTN and CKD. Approximately 200 patients will be randomized in a 1:1:1 ratio into 1 of the 3 treatment groups (placebo, low dose treatment strategy and high dose treatment strategy).
The study will consist of the following 3 periods:
- A Screening Period of up to 5 weeks;
- A Double-Blind Treatment Period of 26 weeks; and
- A Follow-Up Period of 2 weeks.
Patients will complete the study in approximately 8 months.
- Conditions
- Uncontrolled Hypertension, Chronic Kidney Diseases
- Being tested
- CIN-107, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIN-107Drug
Patients will take CIN-107 tablets by mouth once daily.
PlaceboDrug
Patients will take placebo tablets by mouth once daily.
| Study group | Role | What they receive |
|---|---|---|
| Low dose CIN-107 | Experimental | Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks. Receives: Drug: CIN-107 |
| High dose CIN-107 | Experimental | Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks. Receives: Drug: CIN-107 |
| Placebo | Placebo comparator | Patients will take oral tablets of Placebo for 26 weeks. The dose strength may be titrated within 6 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) of Pooled CIN-107 and Placebo
Mean change in seated SBP from baseline to Week 26 of pooled CIN-107 and placebo was assessed.
Measured: At Week 26
Secondary outcomes (2)
Change From Baseline in SBP in CIN-107 Compared to Placebo in Participants Assigned to the High-dose Strategy Group
Mean change in seated SBP from baseline to Week 26 of high-dose CIN-107 dosing group and placebo was assessed.
Measured: At Week 26
Change From Baseline of SBP in CIN-107 Compared to Placebo in Participants Assigned to the Low-dose Strategy Group
The mean change in seated SBP from baseline to Week 26 of low-dose CIN-107 dosing group and placebo was assessed.
Measured: At Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start29 Apr 2022
- Primary completion2 May 2024
- Study completion2 May 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 (2)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432167
- Sponsor's protocol ID
- CIN-107-123
- Other IDs
- D6972C00001
- Status last verified
- Apr 2025
- First submitted
- 20 Jun 2022
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2026 Feb 1;37(2):299-311. doi: 10.1681/ASN.0000000849. Epub 2025 Sep 6.
PubMed 40913594Townsend 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
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05432167
- Acronym / sponsor ID
- CIN-107-123
- Conditions
- Uncontrolled Hypertension, Chronic Kidney Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Posted 20 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of CIN-107 for the treatment of hypertension in patients with uncontrolled hypertension (uHTN) and Chronic Kidney Disease (CKD).
Detailed description
This randomized, double-blind, placebo-controlled will evaluate the efficacy and safety of CIN-107 in patients with uHTN and CKD. Approximately 200 patients will be randomized in a 1:1:1 ratio into 1 of the 3 treatment groups (placebo, low dose treatment strategy and high dose treatment strategy).
The study will consist of the following 3 periods:
- A Screening Period of up to 5 weeks;
- A Double-Blind Treatment Period of 26 weeks; and
- A Follow-Up Period of 2 weeks.
Patients will complete the study in approximately 8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose CIN-107 | Experimental | Drug: CIN-107Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks. |
| High dose CIN-107 | Experimental | Drug: CIN-107Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will take oral tablets of Placebo for 26 weeks. The dose strength may be titrated within 6 weeks. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has a mean seated SBP ≥ 140 mmHg.
- Has a prior diagnosis of mild-to-severe CKD.
- Has an elevated UACR.
- Is currently taking an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at the maximum tolerated daily dose.
Key exclusion criteria (21 listed)
- Have a documented diagnosis of type 1 diabetes.
- Are not willing or not able to discontinue a mineralocorticoid receptor antagonist (MRA) or a potassium sparing diuretic as part of an existing antihypertensive regimen.
- Have a single occurrence of mean seated SBP >180 mmHg or DBP >110 mmHg during the Screening Period.
- Has a body mass index (BMI) >50 kg/m^2.
- Has documented bilateral clinically relevant renal artery stenosis of ≥70%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIN-107Patients will take CIN-107 tablets by mouth once daily. | Drug | High dose CIN-107, Low dose CIN-107 |
| PlaceboPatients will take placebo tablets by mouth once daily. | Drug | Placebo |
Primary outcome
Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) of Pooled CIN-107 and Placebo
Time frame: At Week 26
Mean change in seated SBP from baseline to Week 26 of pooled CIN-107 and placebo was assessed.
2 secondary outcomes
Change From Baseline in SBP in CIN-107 Compared to Placebo in Participants Assigned to the High-dose Strategy Group
Time frame: At Week 26
Change From Baseline of SBP in CIN-107 Compared to Placebo in Participants Assigned to the Low-dose Strategy Group
Time frame: At Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40913594Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2026 Feb 1;37(2):299-311. doi: 10.1681/ASN.0000000849. Epub 2025 Sep 6.
- Derived from this study: PubMed 37490693Townsend 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.
- Redacted CSPLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
71 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CIN-107 in people with Uncontrolled Hypertension and Chronic Kidney Diseases, run by AstraZeneca at 71 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) of Pooled CIN-107 and Placebo (time frame: At Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05432167, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.