Early safety check for new kidney drug begins

NCT ID NCT02653014

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

26 people

The number who actually took part.

Started

Jul 2015

Finished

Mar 2017

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Research by Design, LLC

    Evergreen Park, Illinois, 60805, United States

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