Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease

NCT02837237 | Completed Phase 1 Results FDA Drug

• 1 other identifier: KBP5074-1-003
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-related Adverse Events

  Physical exam, vital signs, EKG, clinical laboratory tests, adverse events

  312 hours

Study Arms (1)

KBP-5074

EXPERIMENTAL

Single oral dose

Drug: KBP-5074

Interventions

KBP-5074 DRUG

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.

Also known as: KBP-5074 mineralocorticoid receptor antagonist

KBP-5074

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[Part 2\]).
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• KBP Biosciences: lead

Study Sites (1)

KBP Biosciences USA Inc

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

KBP-5074

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vincent J. Benn
• Organization: KBP Biosciences Co., Ltd.

vince.benn@kbpbiosciences.com

2677996545

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 19, 2016
• Study Start: July 13, 2016
• Primary Completion: December 20, 2016
• Study Completion: June 30, 2017
• Last Updated: December 30, 2025
• Results First Posted: October 15, 2019

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)