Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic K… (NCT02837237) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease
United States11 participantsStarted 2016-07-13
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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 \[Part 2\]).
Exclusion criteria
✕. 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.
What they're measuring
1
Number of Participants With Treatment-related Adverse Events
✕. 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.
✕. 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.