Can a damaged kidney change how a drug works?

NCT ID NCT07797322

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests how the drug PKN605 moves through the body in people with moderate or severe kidney impairment compared to healthy volunteers. Researchers give a single oral dose and measure drug levels in the blood over time. The goal is to see if reduced kidney function increases drug exposure, which would guide dosing in future studies. Safety is also monitored throughout.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PKN605, an oral tablet taken on an empty stomach
What this could lead to
If it works, this could guide safe dosing of PKN605 for people with kidney impairment in future trials.
What could go wrong
This is an early, small study focused on drug levels, not on treating a disease. Results may not predict how the drug works in larger patient groups.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

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 80 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: All participants (Group 1, 2 \& 3) * Male and female participants 18 to 80 years of age (inclusive). * Weigh at least 50 kg with a body mass index (BMI) within the range of 18 to 42.0 kg/m2, inclusive, at Screening. Participants with moderate and severe RI (Group 1 \& 2) * Have impaired renal function as determined by the mean eGFR calculated using the CKD EPI Creatinine - Cystatin C equation (2021) (refer to Section 8.5.1 for equation), and fall into one of the following groups: * Group 1: moderate RI; eGFR 30 to 60 mL/min, inclusive. * Group 2: severe RI; eGFR \<30 mL/min, not requiring dialysis. * \*The mean eGFR will be calculated from 2 values: one obtained at Screening and a second obtained at least 72 hours later, either at Screening or at the Baseline visit. The mean of these 2 values will be used to assign the renal impairment group. * Have stable renal function with no clinically significant change (no change ≥25% from Screening 1 to Screening 2 or Baseline value) in renal status prior to first dosing of study treatment as determined by the Investigator and is not currently or has not been previously on hemodialysis for at least 1 year. Healthy control participants (Group 3) * Each healthy participant must match the age (±10 years), body weight (±15%), and sex of an individual participant in Group 1 and/or Group 2. * Has normal renal function with eGFR ≥90 mL/min, determined using the CKD-EPI Creatinine - Cystatin C equation (2021) at Screening. Exclusion Criteria: All participants (Group 1, 2 \& 3) * Women of childbearing potential (as defined in the protocol) need to use an effective contraception method during the course of this trial. * History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants such as: * Clinically significant ECG abnormalities that, in the opinion of the Investigator, would place the participant at increased risk. * Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree atrioventricular block without a pacemaker. * History of long QT syndrome or known family history of ventricular arrhythmia or sudden cardiac death. * QT interval corrected by Fridericia's formula (QTcF) \>450 milliseconds (ms) for males and \>460 ms for females, unless considered not clinically significant and not associated with increased arrhythmic risk by the Investigator, with appropriate safety oversight; QTcF must not exceed 470 ms in males and 480 ms in females. * Use of agents known to prolong the QT interval unless they can be discontinued for the duration of study. * Initiation or dose adjustment within \<4 weeks of screening of medications known to cause acute changes in eGFR (e.g., angiotensin-converting-enzyme \[ACE\] inhibitors, angiotensin II receptor blockers \[ARBs\], sodium/glucose cotransporter 2 \[SGLT2\] inhibitors, diuretics, nonsteroidal anti-inflammatory drugs \[NSAIDs\]). Note: NSAIDs are excluded for use in participants with moderate and severe renal impairment (refer to Exclusion criterion 23). * Renal transplant recipients or has had a nephrectomy. Participants with moderate and severe RI (Group 1 \& 2) * Participants requiring dialysis. * Participants taking erythropoiesis-stimulating agents (ESAs) within the last 6 months of Screening and until end of study (EoS) visit. Healthy control participants (Group 3) • History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or blood urea nitrogen and/or urea values, or abnormal urinary constituents or eGFR \<90 mL/min in medical history or at Screening. Other protocol-defined inclusion/exclusion criteria may apply

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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.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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