Chronic Kidney DiseasePhase 1NCT02837237
Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease
A Phase 1 study testing KBP-5074 in people with Chronic Kidney Disease, run by KBP Biosciences at 1 site in United States.
Trial summary
This study explores the use of KBP-5074 in patients with advanced stages of Chronic Kidney Disease (CKD) (including patients with severe renal impairment and those on hemodialysis [HD]) and to assess the safety, tolerability, and pharmacokinetics (PK) of single doses of KBP-5074 in male and female patients with severe… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- KBP-5074
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2016to 30 Jun 2017
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, between 18 and 75 years of age, inclusive.
- Body mass index (BMI) between 19 and 42 kg/m2, inclusive.
- Has severe CKD, defined as eGFR ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2 based on the IDMS traceable15 MDRD equation, according to laboratory results at Screening (non-HD patients only [Part 1]). Patients with a prior history of greater than 2 weeks of dialysis in the past and who have dialyzed in the 6 months prior to dosing on Day 1 will be excluded. Patients who have had temporary dialysis for acute kidney injury will be allowed at the discretion of the Investigator.
- Serum potassium between 3.3 and 4.8 mmol/L, inclusive, at both Screening and Check-in (Day -1) (non-HD patients only [Part 1]). One repeat test will be allowed to exclude lab error or hemolyzed samples.
- Is on a hemodialysis schedule for at least 45 days with KT/V ≥1.2 for end-stage renal disease (ESRD) regardless of the etiology including diabetes, with an average 3 hemodialysis sessions per week (HD patients only [Part 2]).
- Is a nonsmoker or light smoker (smokes fewer than 10 cigarettes per day). Alcohol addressed in exclusion.
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- Female patients cannot be pregnant or lactating/breast-feeding and will either be postmenopausal (female patients who state they are postmenopausal should have had cessation of menses for >1 year and have serum follicle stimulating hormone [FSH] levels >40 mIU/mL and estradiol <20 pg/mL, surgically sterile (including bilateral tubal ligation, salpingectomy [with or without oophorectomy], surgical hysterectomy, or bilateral oophorectomy [with or without hysterectomy]) for at least 3 months prior to Screening, or will agree to use, from the time of Check-in (Day -1) until 90 days following the last dose of study drug, the following forms of contraception: double-barrier method, hormonal contraceptives, barrier with spermicide, diaphragm or cervical cap with spermicide, intrauterine device, oral, implantable, or injectable contraceptives, or a sterile sexual partner. All female patients will have a negative urine or serum pregnancy test result prior to enrollment in the study.
- Male patients will either be surgically sterile or agree to use, from the time of Check-in (Day -1) until 90 days following the last dose of study drug, the following forms of contraception: male condom with spermicide and a female partner who is sterile or agrees to use hormonal contraceptives, female condom with spermicide, diaphragm or cervical cap with spermicide, intrauterine device, oral, implantable, or injectable contraceptives. Male patients will refrain from sperm donation from the time of Check-in (Day -1) until 90 days following the last dose of study drug.
- Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
Who cannot join
- History of any prior or concomitant clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator.
- Has a history or presence of clinically significant (CS) cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, which in the Investigator's opinion would not be suitable for the study from patient safety consideration and could interfere the results of the trial.
- History of CS hypotension during the 6 months prior to the dose of study drug on Day 1 as determined by the Investigator.
- History of symptomatic intradialytic hypotension as determined by the Investigator (mild to moderate decrease in blood pressure during dialysis is allowed; HD patients only [Part 2]).
- History of CS hyperkalemia while on an angiotensin converting enzyme inhibitor, angiotensin receptor blocker, direct renin inhibitor, and/or MRA.
- Hospitalization for hyperkalemia during the last 6 months prior to the dose of study drug on Day 1 or hyperkalemia >5.5 mmol/L during the 2 weeks prior to the Screening visit.
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- History of stroke within 3 months prior to the dose of study drug on Day 1.
- History of cardiac transplant.
- History of severe uncontrolled arrhythmia, acute myocardial infarction, or acute coronary syndrome within 3 months prior to the dose of study drug on Day 1.
- Clinical diagnosis of heart failure and persistent symptoms (New York Heart Association Class II to IV) at either the Screening visit or at Check-in (Day 1).
- History of stomach or intestinal surgery (except that cholecystectomy, appendectomy, and/or hernia repair will be allowed).
- History of prescription drug abuse, illicit drug use, or alcohol abuse according to medical history within 6 months prior to the Screening visit or any alcohol use or for at least 48 hours prior to dosing on Day 1.
- History of clinically significant acute or chronic hepatitis (including infectious, metabolic, autoimmune, genetic, ischemic, or other forms), hepatocirrhosis, or hepatic tumors.
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C (HCV) antibody. If a patient with Severe renal impairment or on HD has positive test results for HCV antibody but liver function tests are otherwise not CS, the patient may be included at the Investigator's discretion.
- Clinically significant abnormal liver function test at screening or Check-in (Day -1), defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times upper limit of normal (ULN) or total bilirubin >ULN.
- Recent (within 3 month prior to the dose of study drug on Day 1) or planned coronary revascularization by angioplasty or cardiovascular surgery (excluding HD vascular access).
- Kidney transplant scheduled within the year.
- Systolic blood pressure <90 or >200 mmHg and/or diastolic blood pressure <60 or >110 mmHg during the Screening visit and before the dose of study drug on Day 1; may be repeated at the discretion of the Investigator.
- Positive screen for alcohol or drugs of abuse (except for patients with a positive drug screen test if it is a result of a prescribed medication from their physician) at Screening and Check-in (Day -1). Hemodialysis patients will be tested with serum drug screen at Screening and using salivary testing at Check-in (Day -1).
- Female is pregnant or breastfeeding within 2 years prior to the dose of study drug on Day 1 or positive pregnancy test (serum/urine) result during the Screening visit and before the dose of study drug on Day 1. Patients who have a false positive test attributable to their post-menopausal state or kidney disease, as determined by the Investigator, will be allowed to participate.
- Has a known hypersensitivity to KBP-5074, aldosterone antagonists, or related compounds.
- Receipt of any other investigational product within 30 days or 5 half-lives (whichever is longer) prior to the dose of study drug on Day 1.
- Currently on a MRA (eg, spironolactone, eplerenone) or potassium sparing diuretics (eg, amiloride, triamterene).
- Concomitant use of or treatment with any prescription drugs, herbal products, vitamins, minerals, and over-the-counter medications within 14 days prior to Check in (Day -1) and during the study. Exceptions may be made on a case by case basis following discussion and agreement between the Investigator and the Sponsor. Patients requiring HD (Part 2) may continue to receive routine medications (including vitamins, antidepressants, antihypertensive, and low dose aspirin) to maintain their stable medication regimen.
- Use of any nutrients known to modulate cytochrome P450 (CYP)3A activity (based on the KBP-5074 metabolic pathway) or any strong or moderate inhibitors or inducers of CYP3A4, starting from 14 days prior to dose administration on Day 1 until the final end of study assessments, including but not limited to the following: inhibitors such as ketoconazole, miconazole, itraconazole, fluconazole, atazanavir, erythromycin, clarithromycin, ranitidine, cimetidine, verapamil, and diltiazem and inducers such as rifampicin, rifabutin, glucocorticoids, carbamazepine, phenytoin, phenobarbital, and St. John's wort.
- Participated in strenuous exercise from 48 hours prior to Check-in (Day -1) or during the study through the final end of study assessment.
- Has donated or lost a significant volume (>500 mL) of blood or plasma within 30 days prior to Check-in (Day -1).
- Is an employee or family member of the Investigator or study site personnel.
- Has problems understanding the protocol requirements, instructions, study related restrictions, and/or problems understanding the nature, scope, and potential consequences of participating in this clinical study.
- Is unlikely to comply with the protocol requirements, instructions, and/or study related restrictions (eg, uncooperative attitude, unavailable for follow up call, and/or improbability of completing the clinical study).
Trial locations and contacts
1 site in 1 country.
United States1 site
KBP Biosciences USA Inc
Princeton, New Jersey, 08540
About this study
Official title: A Phase 1, Open-Label Study in Hemodialysis and Non-Hemodialysis Patients With Severe Chronic Kidney Disease to Evaluate the Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration
This study explores the use of KBP-5074 in patients with advanced stages of Chronic Kidney Disease (CKD) (including patients with severe renal impairment and those on hemodialysis [HD]) and to assess the safety, tolerability, and pharmacokinetics (PK) of single doses of KBP-5074 in male and female patients with severe CKD (defined as estimated glomerular filtration rate [eGFR] ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2, based on the Modification of Diet in Renal Disease [MDRD] equation) and a subset of patients requiring HD.
Read the detailed description
This is a Phase 1, multicenter, open-label, 2-part study designed to assess the PK, safety, and tolerability of KBP-5074 in patients undergoing HD and non-HD patients with severe CKD (defined using the eGFR ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2 based on the MDRD equation). The study will be conducted at up to 4 clinical research units (CRUs) in the US. Approximately 12 patients will be enrolled in the study (a single cohort of 6 patients in each of Part 1 and Part 2). Parts 1 and 2 of the study will be conducted in parallel. If Part 1 is completed prior to the completion of Part 2, or vice versa, the PK, safety, and tolerability analyses for the completed study part may proceed as planned and will not be delayed based on the timing of the other respective study part.
- Conditions
- Chronic Kidney Disease
- Being tested
- KBP-5074
- 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.
KBP-5074Drug
Also called KBP-5074 mineralocorticoid receptor antagonist
In Part 1 of the study, non-HD patients with severe CKD in Cohort 1 will receive a single oral capsule dose of KBP-5074 on Day 1 following a fast between 2 and 4 hours.
In Part 2 of the study, HD patients with severe CKD will receive a single oral capsule dose of KBP-5074 following a fast between 2 and 4 hours. The dose of KBP 5074 will be administered on Day 1 immediately following a dialysis session.
| Study group | Role | What they receive |
|---|---|---|
| KBP-5074 | Experimental | Single oral dose Receives: Drug: KBP-5074 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events
Physical exam, vital signs, EKG, clinical laboratory tests, adverse events
Measured: 312 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start13 Jul 2016
- Primary completion20 Dec 2016
- Study completion30 Jun 2017
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.
- Other trials for Chronic Kidney DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- KBP Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837237
- Sponsor's protocol ID
- KBP5074-1-003
- Status last verified
- Dec 2025
- First submitted
- 11 Jul 2016
- Last updated
- 30 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study in Hemodialysis and Non-Hemodialysis Patients With Severe Chronic Kidney Disease to Evaluate the Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration
- ClinicalTrials.gov ID
- NCT02837237
- Acronym / sponsor ID
- KBP5074-1-003
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- KBP BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2016 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Posted 15 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores the use of KBP-5074 in patients with advanced stages of Chronic Kidney Disease (CKD) (including patients with severe renal impairment and those on hemodialysis [HD]) and to assess the safety, tolerability, and pharmacokinetics (PK) of single doses of KBP-5074 in male and female patients with severe CKD (defined as estimated glomerular filtration rate [eGFR] ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2, based on the Modification of Diet in Renal Disease [MDRD] equation) and a subset of patients requiring HD.
Detailed description
This is a Phase 1, multicenter, open-label, 2-part study designed to assess the PK, safety, and tolerability of KBP-5074 in patients undergoing HD and non-HD patients with severe CKD (defined using the eGFR ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2 based on the MDRD equation). The study will be conducted at up to 4 clinical research units (CRUs) in the US. Approximately 12 patients will be enrolled in the study (a single cohort of 6 patients in each of Part 1 and Part 2). Parts 1 and 2 of the study will be conducted in parallel. If Part 1 is completed prior to the completion of Part 2, or vice versa, the PK, safety, and tolerability analyses for the completed study part may proceed as planned and will not be delayed based on the timing of the other respective study part.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KBP-5074 | Experimental | Drug: KBP-5074Single oral dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, between 18 and 75 years of age, inclusive.
- Body mass index (BMI) between 19 and 42 kg/m2, inclusive.
- Has severe CKD, defined as eGFR ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2 based on the IDMS traceable15 MDRD equation, according to laboratory results at Screening (non-HD patients only [Part 1]). Patients with a prior history of greater than 2 weeks of dialysis in the past and who have dialyzed in the 6 months prior to dosing on Day 1 will be excluded. Patients who have had temporary dialysis for acute kidney injury will be allowed at the discretion of the Investigator.
- Serum potassium between 3.3 and 4.8 mmol/L, inclusive, at both Screening and Check-in (Day -1) (non-HD patients only [Part 1]). One repeat test will be allowed to exclude lab error or hemolyzed samples.
- Is on a hemodialysis schedule for at least 45 days with KT/V ≥1.2 for end-stage renal disease (ESRD) regardless of the etiology including diabetes, with an average 3 hemodialysis sessions per week (HD patients only [Part 2]).
Key exclusion criteria (30 listed)
- History of any prior or concomitant clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator.
- Has a history or presence of clinically significant (CS) cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, which in the Investigator's opinion would not be suitable for the study from patient safety consideration and could interfere the results of the trial.
- History of CS hypotension during the 6 months prior to the dose of study drug on Day 1 as determined by the Investigator.
- History of symptomatic intradialytic hypotension as determined by the Investigator (mild to moderate decrease in blood pressure during dialysis is allowed; HD patients only [Part 2]).
- History of CS hyperkalemia while on an angiotensin converting enzyme inhibitor, angiotensin receptor blocker, direct renin inhibitor, and/or MRA.
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: KBP-5074 mineralocorticoid receptor antagonistIn Part 1 of the study, non-HD patients with severe CKD in Cohort 1 will receive a single oral capsule dose of KBP-5074 on Day 1 following a fast between 2 and 4 hours. In Part 2 of the study, HD patients with severe CKD will receive a single oral capsule dose of KBP-5074 following a fast between 2 and 4 hours. The dose of KBP 5074 will be administered on Day 1 immediately following a dialysis session. | Drug | KBP-5074 |
Primary outcome
Number of Participants With Treatment-related Adverse Events
Time frame: 312 hours
Physical exam, vital signs, EKG, clinical laboratory tests, adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Chronic Kidney Disease, 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 30 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 30 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?
Yes. Results are posted in the registry (first posted 15 Oct 2019). 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?
Number of Participants With Treatment-related Adverse Events (time frame: 312 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2025.