A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease

Sponsor

CinCor Pharma, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05432167

Collaborator

Parexel (Industry)

300

Enrollment

Locations

Arms

16.2

Anticipated Duration (Months)

6.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy and safety of CIN-107 for the treatment of hypertension in patients with uncontrolled hypertension and Chronic Kidney Disease (CKD).

Condition or Disease	Intervention/Treatment	Phase
Uncontrolled Hypertension Chronic Kidney Diseases	Drug: CIN-107 Drug: Placebo	Phase 2

Detailed Description

This randomized, double-blind, placebo-controlled will evaluate the efficacy and safety of CIN-107 in patients with uncontrolled hypertension and CKD. Approximately 300 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 4 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

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 27, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low dose CIN-107 Patients will take oral tablets of CIN-107 Dose A for 26 weeks. Patients may up-titrate to take CIN-107 1 Dose B at week 3.	Drug: CIN-107 Patients will take CIN-107 tablets by mouth once daily.
Experimental: High dose CIN-107 Patients will take oral tablets of CIN-107 Dose C for 26 weeks. Patients may up-titrate to take CIN-107 Dose D at week 3.	Drug: CIN-107 Patients will take CIN-107 tablets by mouth once daily.
Placebo Comparator: Placebo Patients will take oral tablets of Placebo for 26 weeks.	Drug: Placebo Patients will take placebo tablets by mouth once daily.

Arm

Intervention/Treatment

Experimental: Low dose CIN-107

Patients will take oral tablets of CIN-107 Dose A for 26 weeks. Patients may up-titrate to take CIN-107 1 Dose B at week 3.

Drug: CIN-107

Patients will take CIN-107 tablets by mouth once daily.

Experimental: High dose CIN-107

Patients will take oral tablets of CIN-107 Dose C for 26 weeks. Patients may up-titrate to take CIN-107 Dose D at week 3.

Drug: CIN-107

Patients will take CIN-107 tablets by mouth once daily.

Placebo Comparator: Placebo

Patients will take oral tablets of Placebo for 26 weeks.

Drug: Placebo

Patients will take placebo tablets by mouth once daily.

Outcome Measures

Primary Outcome Measures

Change from baseline in mean seated systolic blood pressure (SBP) [At Week 26]

Secondary Outcome Measures

Change from baseline in SBP [At Week 26]
Percentage of patients achieving SBP <130mmHg [At Week 26]
Change from baseline in urinary albumin-to-creatinine ratio (UACR) [At Week 26]
Change from baseline in diastolic blood pressure (DBP) [At Week 26]
Change from baseline in estimated glomerular filtration rate (eGFR) [At Week 26]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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) >45 kg/m2.
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.
Has known documented chronic heart failure New York Heart Association class III or 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 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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CinCor Site 8	Birmingham	Alabama	United States	35209
2	CinCor Site 63	Huntsville	Alabama	United States	35805
3	CinCor Site 3	Azusa	California	United States	91702
4	CinCor Site 50	Beverly Hills	California	United States	90211
5	CinCor Site 44	Chula Vista	California	United States	91910
6	CinCor Site 56	Lancaster	California	United States	93534
7	CinCor Site 30	Lincoln	California	United States	95648
8	CinCor Site 21	Los Angeles	California	United States	90026
9	CinCor Site 42	Los Angeles	California	United States	90057-3550
10	CinCor Site 72	Lynwood	California	United States	90262
11	CinCor Site 27	Northridge	California	United States	91324
12	CinCor Site 79	Northridge	California	United States	91324
13	CinCor Site 26	Orange	California	United States	92708
14	CinCor Site 70	Riverside	California	United States	92504
15	CinCor Site 6	S. Gate	California	United States	90280
16	CinCor Site 76	Tarzana	California	United States	91356
17	CinCor Site 4	Victorville	California	United States	92392
18	CinCor Site 37	Arvada	Colorado	United States	80002
19	CinCor Site 47	Orlando	Florida	United States	32808
20	CinCor Site 73	West Palm Beach	Florida	United States	33401
21	CinCor Site 22	Columbus	Georgia	United States	31904
22	CinCor Site 7	Suwanee	Georgia	United States	30024
23	CinCor Site 29	Chicago	Illinois	United States	60643
24	CinCor Site 24	Kansas City	Kansas	United States	64111
25	CinCor Site 59	Metairie	Louisiana	United States	70006
26	CinCor Site 23	Monroe	Louisiana	United States	71201
27	CinCor Site 45	Flint	Michigan	United States	48504
28	CinCor Site 19	Flint	Michigan	United States	48532
29	CinCor Site 39	Troy	Michigan	United States	48085
30	CinCor Site 1	Olive Branch	Mississippi	United States	38654
31	CinCor Site 2	Bronx	New York	United States	10455
32	CinCor Site 16	Durham	North Carolina	United States	27704
33	CinCor Site 10	Greenville	North Carolina	United States	27834
34	CinCor Site 5	Kinston	North Carolina	United States	28504
35	CinCor Site 9	Morganton	North Carolina	United States	28655
36	CinCor Site 48	Wilmington	North Carolina	United States	28401
37	CinCor Site 33	Spartanburg	South Carolina	United States	29306
38	CinCor Site 58	Memphis	Tennessee	United States	38119
39	CinCor Site 12	Houston	Texas	United States	77099
40	CinCor Site 66	Lampasas	Texas	United States	76550
41	CinCor Site 13	Missouri City	Texas	United States	77459
42	CinCor Site 51	Paris	Texas	United States	75462
43	CinCor Site 57	Red Oak	Texas	United States	75154
44	CinCor Site 14	Shenandoah	Texas	United States	77384
45	CinCor Site 18	Burke	Virginia	United States	22015
46	CinCor Site 75	Manassas	Virginia	United States	20110

Sponsors and Collaborators

CinCor Pharma, Inc.
Parexel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CinCor Pharma, Inc.

ClinicalTrials.gov Identifier:

NCT05432167

Other Study ID Numbers:

CIN-107-123

First Posted:

Jun 27, 2022

Last Update Posted:

Aug 12, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Hypertension

Study Results

No Results Posted as of Aug 12, 2022