Early safety check for new kidney drug begins
NCT ID NCT02653014
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested the safety and tolerability of a new drug called KBP-5074 in 26 adults, including healthy volunteers and those with mild to moderate kidney impairment. Researchers measured how the drug moves through the body and its effects on blood pressure and potassium levels. The goal was to gather information to help design larger future studies.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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26 people
The number who actually took part.
- Started
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Jul 2015
- Finished
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Mar 2017
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for Part 1: * 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. Exclusion Criteria for Part 1: * 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. Inclusion Criteria for Part 2: * 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); * 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. Exclusion Criteria for Part 2: * 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; * 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research by Design, LLC
Evergreen Park, Illinois, 60805, United States
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