HealthyPhase 1NCT02653014

Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects and Subjects With Renal Impairment

A Phase 1 study testing KBP-5074 in people with Healthy and Renal Insufficiency, run by KBP Biosciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Renal Insufficiency
What is being tested?: KBP-5074
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 29 Jul 2015to 28 Mar 2017
Phase: Phase 1
Are there results?: None posted in the registry

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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male or female subject
Are between the ages of 18 and 45 years (inclusive);
Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg.
Are between the ages of 18 and 75 years (inclusive);
Mild to moderate chronic kidney disease (defined as estimated glomerular filtration rate (eGFR) > 30 and ≤89 mL/min/1.73 m2, using the modification of diet in renal disease (MDRD) formula, for > 3 months;
Proteinuria (defined as urine albumin to creatinine ratio (UACR) ≥100 mg/g and ≤3,000 mg/g in two mid-morning urine specimens within a month interval);

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Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
Serum potassium≥3.3 mmol/L and ≤4.8 mmol/L;
Body mass index (BMI) of 19 to 40 kg/m2 inclusive and body weight not less than 50 kg.

Who cannot join

Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
Known or suspected malignancy;
Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody;
Positive pregnancy test result.
Severe uncontrolled hypertension (diastolic > 115 mmHg or systolic blood pressure > 180 mmHg) at either the Screening visit or the Study Check-in Visit;
Type I diabetes mellitus or poorly controlled Type 2 diabetes mellitus (HbA1c > 10%) at the Screening visit;

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Prior kidney transplant, or anticipated need for transplant during study participation;
Clinical diagnosis of heart failure and persistent symptoms (New York Heart Association [NYHA] Class II- IV) at either the Screening visit or the Study Check-in Visit;
Known or suspected contraindications to study medications, including history of hypersensitivity or allergy to ACE inhibitors, ARBs, or aldosterone antagonists;
Any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history, which in the investigators opinion could interfere with the results of the trial;
Diabetic gastroparesis;
Known bilateral clinically relevant renal artery stenosis (>75% reduction in artery diameter).

Trial locations and contacts

1 site in 1 country.

United States1 site

Research by Design, LLC
Evergreen Park, Illinois, 60805

Other trials in United States

About this study

Official title: An Open-Label, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects With a Separate Panel in Subjects With Mild to Moderate Renal Impairment

This multiple ascending dose (MAD) study in healthy subjects and subjects with mild to moderate renal impairment will evaluate the safety, tolerability and pharmacokinetics of KBP-5074. Safety/tolerability data and Pharmacokinetics (PK)/Pharmacodynamics (PD) (plasma aldosterone, serum potassium, UACR and Blood Pressure) relationships will be explored to support the selection of dosing regimens of KBP-5074 that are suitable for the Phase II/III study.

Read the detailed description

This study consists of two parts: Part 1 is an open-label, multiple ascending dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of KBP-5074 in healthy subjects. The safety and tolerability will be assessed at each dose level before progressing to the next higher dose. Part 2 is an open label, randomized, parallel study to assess the safety and tolerability, the effect of renal dysfunction on the pharmacokinetics of KBP-5074, as well as the PK/PD relationship in subjects with mild to moderate renal impairment.

Conditions: Healthy, Renal Insufficiency
Being tested: KBP-5074
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KBP-5074Drug
Also called mineralocorticoid receptor antagonist

Study groups in NCT02653014
Study group	Role	What they receive
Cohort 1	Experimental	Healthy Volunteers will receive 2.5mg of KBP-5074, QD, 14 days Receives: Drug: KBP-5074
Cohort 2	Experimental	Healthy Volunteers will receive 5.0mg of KBP-5074, QD, 14 days Receives: Drug: KBP-5074
Cohort 3	Experimental	Subjects with mild to moderate renal impairment will receive 0.5mg of KBP-5074, QD, 56 days Receives: Drug: KBP-5074
Cohort 4	Experimental	Subjects with mild to moderate renal impairment will receive 2.5mg of KBP-5074, QD, 56 days Receives: Drug: KBP-5074

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and tolerability
Rate of adverse events
Measured: Up to 69 days

Secondary outcomes (9)

Area Under Curve (AUC) in healthy subjects
AUC 0-24 hours
Measured: pre-dose and 2, 4, 6, 8, 10, 12, 18, and 24 hours post dose on Day 1; pre-dose on Days 8, 11, 12, and 13; and pre-dose and 2, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 168, 216, 264, and 312 hours post dose on Day 14
Area Under Curve (AUC) in subjects with mild to moderate renal impairment
AUC 0-24 hours
Measured: pre-dose and 2, 4, 6, 8, 10, 12, 18, and 24 hours post dose on Day 1; pre-dose on Days 8, 11, 12, and 13; pre-dose and 2, 4, 6, 8, 10, 12, 18, and 24 hours post dose on Day 14; pre-dose on Days 29 and 43; and pre-dose and 6, 12, and 24 hours on Day 56
The effect of mild to moderate renal impairment on the Area Under Curve (AUC)
AUC 0-24 hours
Measured: Up to 15 days
Plasma aldosterone levels in healthy subjects
Plasma aldosterone level
Measured: Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Day 8; and 24 hours post last dose on Day 15
Serum potassium levels in healthy subjects
Serum potassium level
Measured: Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Day 8; and 24 hours post last dose on Day 15
Plasma aldosterone levels in subjects with mild to moderate renal impairment
Plasma aldosterone level
Measured: Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57
Serum potassium levels in subjects with mild to moderate renal impairment
Serum potassium level
Measured: Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57
Urinary Albumin to Creatinine Ratio (UACR) in subjects with mild to moderate renal impairment
Ratio of urinary albumin level to creatinine level
Measured: Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57
Blood Pressure in subjects with mild to moderate renal impairment
Systolic and diastolic seated blood pressure
Measured: Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 201528 Mar 2017

First posted12 Jan 2016 (estimated)
Study start29 Jul 2015
Primary completion26 May 2016
Study completion28 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02653014
Sponsor's protocol ID: KBP5074-1-002
Status last verified: Dec 2025
First submitted: 29 Dec 2015
Last updated: 16 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects With a Separate Panel in Subjects With Mild to Moderate Renal Impairment
ClinicalTrials.gov ID: NCT02653014
Acronym / sponsor ID: KBP5074-1-002
Conditions: Healthy, Renal Insufficiency
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: KBP BiosciencesIndustry (pharma, biotech, devices)
Study start: 29 Jul 2015 (actual)
Primary completion: 26 May 2016 (actual)
Study completion: 28 Mar 2017 (actual)
First posted: 12 Jan 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Cohort 1	Experimental	Drug: KBP-5074Healthy Volunteers will receive 2.5mg of KBP-5074, QD, 14 days
Cohort 2	Experimental	Drug: KBP-5074Healthy Volunteers will receive 5.0mg of KBP-5074, QD, 14 days
Cohort 3	Experimental	Drug: KBP-5074Subjects with mild to moderate renal impairment will receive 0.5mg of KBP-5074, QD, 56 days
Cohort 4	Experimental	Drug: KBP-5074Subjects with mild to moderate renal impairment will receive 2.5mg of KBP-5074, QD, 56 days

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Healthy male or female subject
Are between the ages of 18 and 45 years (inclusive);
Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg.
Are between the ages of 18 and 75 years (inclusive);
Mild to moderate chronic kidney disease (defined as estimated glomerular filtration rate (eGFR) > 30 and ≤89 mL/min/1.73 m2, using the modification of diet in renal disease (MDRD) formula, for > 3 months;

Key exclusion criteria (12 listed)

Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
Known or suspected malignancy;
Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody;
Positive pregnancy test result.
Severe uncontrolled hypertension (diastolic > 115 mmHg or systolic blood pressure > 180 mmHg) at either the Screening visit or the Study Check-in Visit;

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
KBP-5074Also: mineralocorticoid receptor antagonist	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4

Primary outcome

Safety and tolerability
Time frame: Up to 69 days
Rate of adverse events

9 secondary outcomes

Area Under Curve (AUC) in healthy subjects
Time frame: pre-dose and 2, 4, 6, 8, 10, 12, 18, and 24 hours post dose on Day 1; pre-dose on Days 8, 11, 12, and 13; and pre-dose and 2, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 168, 216, 264, and 312 hours post dose on Day 14
Area Under Curve (AUC) in subjects with mild to moderate renal impairment
Time frame: pre-dose and 2, 4, 6, 8, 10, 12, 18, and 24 hours post dose on Day 1; pre-dose on Days 8, 11, 12, and 13; pre-dose and 2, 4, 6, 8, 10, 12, 18, and 24 hours post dose on Day 14; pre-dose on Days 29 and 43; and pre-dose and 6, 12, and 24 hours on Day 56
The effect of mild to moderate renal impairment on the Area Under Curve (AUC)
Time frame: Up to 15 days
Plasma aldosterone levels in healthy subjects
Time frame: Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Day 8; and 24 hours post last dose on Day 15
Serum potassium levels in healthy subjects
Time frame: Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Day 8; and 24 hours post last dose on Day 15
Plasma aldosterone levels in subjects with mild to moderate renal impairment
Time frame: Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57
Serum potassium levels in subjects with mild to moderate renal impairment
Time frame: Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57
Urinary Albumin to Creatinine Ratio (UACR) in subjects with mild to moderate renal impairment
Time frame: Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57
Blood Pressure in subjects with mild to moderate renal impairment
Time frame: Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Individual participant dataSharing planned: No

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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KBP-5074 in people with Healthy and Renal Insufficiency, run by KBP Biosciences at 1 site 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 9 inclusion and 12 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 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety and tolerability (time frame: Up to 69 days). 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 NCT02653014.

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 16 Dec 2025.