A Study to Evaluate CIN-107 for the Treatment of Patients... | NCT05432167

ID	Type	Description	Link
D6972C00001	Other Identifier	AstraZeneca

Status Module

Name	Class
Parexel	INDUSTRY

Label	Type	Description	Intervention Names
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.	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.	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.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
CIN-107	Drug	Patients will take CIN-107 tablets by mouth once daily.	High dose CIN-107 Low dose CIN-107

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	At Week 26

Secondary Outcomes

Measure	Description	Time Frame
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.	At Week 26
Change From Baseline of SBP in CIN-107 Compared to Placebo in Participants Assigned to the Low-dose Strategy Group

Other Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	The safety and tolerability of CIN-107 in participants with uncontrolled hypertension (uHTN) and chronic kidney disease (CKD) was assessed. Adverse events of special interest (AESI) include any hypotension events, abnormal potassium or sodium laboratory values that require clinical intervention.	From randomization (Day 1) until the end of Follow up period (approximately 8 months)

Eligibility Module

Eligibility Criteria

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) >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.
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.

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35209	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
40913594	Derived	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.
37490693	Derived

Label	URL
Redacted CSP	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	CIN-107 Low Dosing Strategy Group	Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks.
FG001	CIN-107 High Dosing Strategy Group	Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 17, 2023	May 2, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Modified Intent-to-treat (mITT) population included all participants in the ITT population who received at least 1 dose of any study drug.

Here, 'overall number of participants analyzed' means the number of participants with non-missing data.

Posted

Least Squares Mean

Standard Error

Millimeters of mercury (mmHg)

At Week 26

ID	Title	Description
OG000	CIN-107 Treatment Groups Pooled	Participants received oral tablets of high and low doses of CIN-107 for 26 weeks.
OG001	Placebo	Participants received oral tablets of Placebo for 26 weeks.

Units	Counts
Participants	OG000105 OG00148

Title

Denominators

Categories

Title	Measurements
	OG000-15.22± 1.532 OG001-7.15± 2.231

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.	Mixed Models Analysis		0.003		Mean Difference (Final Values)	-8.08	Standard Error of the Mean	2.676	2-Sided	95	-13.36	-2.79					Superiority

Secondary

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.

mITT population included all participants in the ITT population who received at least 1 dose of any study drug.

Posted

Least Squares Mean

Standard Error

mmHg

At Week 26

ID	Title	Description
OG000	CIN-107 High Dosing Strategy Group	Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks.
OG001	Placebo	Participants received oral tablets of Placebo for 26 weeks.

Units	Counts
Participants	OG000

Secondary

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.

mITT population included all participants in the ITT population who received at least 1 dose of any study drug.

Posted

Least Squares Mean

Standard Error

mmHg

At Week 26

ID	Title	Description
OG000	CIN-107 Low Dosing Strategy Group	Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks.
OG001	Placebo	Participants received oral tablets of Placebo for 26 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

The safety and tolerability of CIN-107 in participants with uncontrolled hypertension (uHTN) and chronic kidney disease (CKD) was assessed.

Adverse events of special interest (AESI) include any hypotension events, abnormal potassium or sodium laboratory values that require clinical intervention.

Safety population included all participants who received at least one dose of any study drug.

Posted

Count of Participants

Participants

From randomization (Day 1) until the end of Follow up period (approximately 8 months)

ID	Title	Description
OG000	CIN-107 Low Dosing Strategy Group	Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks.
OG001	CIN-107 High Dosing Strategy Group	Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks.
OG002	Placebo	Participants received oral tablets of Placebo for 26 weeks.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cellulitis	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Eye infection	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Pneumonia	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA version 27.0	Non-systematic Assessment	EG0002 events2 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0022 events1 affected64 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Deep vein thrombosis	Vascular disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Hypertension	Vascular disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Proctalgia	Gastrointestinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA version 27.0	Non-systematic Assessment	EG0003 events3 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Chest pain	General disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Generalised oedema	General disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA version 27.0	Non-systematic Assessment	EG00030 events21 affected65 at risk EG00152 events32 affected63 at risk EG0024 events3 affected64 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 27.0	Non-systematic Assessment	EG0005 events4 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Blood creatinine increased	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG00014 events11 affected65 at risk EG00120 events15 affected63 at risk EG0027 events5 affected64 at risk
Glomerular filtration rate decreased	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0002 events2 affected65 at risk EG0014 events4 affected63 at risk EG0026 events5 affected64 at risk
Lipase increased	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0003 events2 affected65 at risk EG0013 events3 affected63 at risk EG0021 events1 affected64 at risk
Blood potassium increased	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0004 events4 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Blood urea increased	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0002 events2 affected65 at risk EG0012 events2 affected63 at risk EG0020 events0 affected64 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Amylase increased	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0002 events2 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0022 events2 affected64 at risk
SARS-CoV-2 test positive	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Alanine aminotransferase increased	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Blood bicarbonate decreased	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Blood glucose decreased	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Cardiac murmur	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Electrocardiogram QRS complex shortened	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Electrocardiogram QT interval abnormal	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Electrocardiogram abnormal	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Eosinophil count increased	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Helicobacter test positive	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Hepatic enzyme increased	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Influenza A virus test positive	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
International normalised ratio increased	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Liver function test abnormal	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Urinary tract infection	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0003 events3 affected65 at risk EG0012 events1 affected63 at risk EG0025 events2 affected64 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0002 events1 affected65 at risk EG0013 events3 affected63 at risk EG0021 events1 affected64 at risk
COVID-19	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0002 events2 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Nasopharyngitis	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0011 events1 affected63 at risk EG0021 events1 affected64 at risk
Cystitis	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Gastroenteritis	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0021 events1 affected64 at risk
Cellulitis	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0003 events2 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Bronchitis	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Diverticulitis	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Folliculitis	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Gangrene	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Gastroenteritis viral	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Tinea capitis	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Trichomoniasis	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Soft tissue infection	Infections and infestations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0022 events1 affected64 at risk
Renal impairment	Renal and urinary disorders	MedDRA version 27.0	Non-systematic Assessment	EG0002 events2 affected65 at risk EG0015 events5 affected63 at risk EG0023 events3 affected64 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA version 27.0	Non-systematic Assessment	EG0002 events2 affected65 at risk EG0012 events2 affected63 at risk EG0023 events3 affected64 at risk
Haematuria	Renal and urinary disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0022 events2 affected64 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0024 events4 affected64 at risk
Dysuria	Renal and urinary disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Renal failure	Renal and urinary disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0012 events1 affected63 at risk EG0021 events1 affected64 at risk
IgA nephropathy	Renal and urinary disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Proteinuria	Renal and urinary disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Urine odour abnormal	Renal and urinary disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0002 events2 affected65 at risk EG0015 events5 affected63 at risk EG0022 events2 affected64 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0012 events2 affected63 at risk EG0021 events1 affected64 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0021 events1 affected64 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0012 events2 affected63 at risk EG0020 events0 affected64 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Orthostatic hypotension	Vascular disorders	MedDRA version 27.0	Non-systematic Assessment	EG0003 events2 affected65 at risk EG0012 events2 affected63 at risk EG0024 events4 affected64 at risk
Hypotension	Vascular disorders	MedDRA version 27.0	Non-systematic Assessment	EG0003 events3 affected65 at risk EG0012 events2 affected63 at risk EG0023 events2 affected64 at risk
Hypertension	Vascular disorders	MedDRA version 27.0	Non-systematic Assessment	EG0002 events2 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Arteriosclerosis	Vascular disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Hypertensive crisis	Vascular disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0003 events3 affected65 at risk EG0013 events3 affected63 at risk EG0021 events1 affected64 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0002 events2 affected65 at risk EG0012 events2 affected63 at risk EG0021 events1 affected64 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0002 events1 affected65 at risk EG0011 events1 affected63 at risk EG0023 events3 affected64 at risk
Dental caries	Gastrointestinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Constipation	Gastrointestinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Flatulence	Gastrointestinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Overflow diarrhoea	Gastrointestinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Oedema peripheral	General disorders	MedDRA version 27.0	Non-systematic Assessment	EG0002 events2 affected65 at risk EG0012 events2 affected63 at risk EG0021 events1 affected64 at risk
Fatigue	General disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Pyrexia	General disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Chest discomfort	General disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Chest pain	General disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Feeling cold	General disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Malaise	General disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Mass	General disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Peripheral swelling	General disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Swelling	General disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Tachycardia	Cardiac disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Bradycardia	Cardiac disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0022 events1 affected64 at risk
Atrial fibrillation	Cardiac disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Arrhythmia	Cardiac disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Atrial flutter	Cardiac disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Left ventricular failure	Cardiac disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Palpitations	Cardiac disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0002 events2 affected65 at risk EG0011 events1 affected63 at risk EG0023 events3 affected64 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0022 events1 affected64 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0011 events1 affected63 at risk EG0021 events1 affected64 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Dizziness	Nervous system disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0011 events1 affected63 at risk EG0021 events1 affected64 at risk
Headache	Nervous system disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0013 events3 affected63 at risk EG0021 events1 affected64 at risk
Hypoaesthesia	Nervous system disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0012 events2 affected63 at risk EG0021 events1 affected64 at risk
Syncope	Nervous system disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Paraesthesia	Nervous system disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0023 events2 affected64 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Fall	Injury, poisoning and procedural complications	MedDRA version 27.0	Non-systematic Assessment	EG0002 events2 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Diplopia	Eye disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Eye pain	Eye disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Glaucoma	Eye disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Ocular discomfort	Eye disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Ocular hypertension	Eye disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Malignant neoplasm of eye	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 27.0	Non-systematic Assessment	EG0002 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected63 at risk EG0021 events1 affected64 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Hypoparathyroidism	Endocrine disorders	MedDRA version 27.0	Non-systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected63 at risk EG0020 events0 affected64 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Depression	Psychiatric disorders	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk
Blood uric acid increased	Investigations	MedDRA version 27.0	Non-systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected63 at risk EG0020 events0 affected64 at risk

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	CIN-107 Low Dosing Strategy Group	Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks.
BG001	CIN-107 High Dosing Strategy Group	Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks.
BG002	Placebo	Participants received oral tablets of Placebo for 26 weeks.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CIN-107 Low Dosing Strategy Group	Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks.	65	7	65	47	65
EG001	CIN-107 High Dosing Strategy Group	Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks.	63	5	63	52	63
EG002	Placebo	Participants received oral tablets of Placebo for 26 weeks.	64	2	64	35	64