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Kidney function may change how olpasiran works

NCT ID NCT05489614

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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-phase study looked at how a single dose of the drug olpasiran moves through the body in people with normal kidneys and those with various levels of kidney impairment. Thirty-three adults received one shot under the skin. The main goal was to measure drug levels in the blood and check safety, not to treat any condition. Results will help guide future dosing for patients with kidney disease.

What this could mean

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

Active substance
Olpasiran (a drug given as a shot under the skin)
What this could lead to
If successful, this study could help doctors decide the right dose of olpasiran for patients with kidney problems.
What could go wrong
This was a very early, small study (33 people) focused on drug levels, not on treating disease. It does not prove olpasiran works or is safe for long-term use.

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

33 people

The number who actually took part.

Started

Sep 2022

Finished

Dec 2023

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: * Male participants or female participants of nonchildbearing potential between 18 and 75 years of age (inclusive) at the time of Screening. * Body mass index between 18 and 40 kg/m\^2 (inclusive) at the time of Screening. * Eligible participants classified based on established need for renal replacement therapy and eGFR at Screening. Assignment will be based on eGFR at Screening. 1. Group 1 (Normal): eGFR ≥ 90 mL/min and no history of renal disease. 2. Group 2 (Mild): 60 ≤ eGFR ≤ 89 mL/min. 3. Group 3 (Moderate): 30 ≤ eGFR ≤ 59 mL/min. 4. Group 4 (Severe): 15 ≤ eGFR ≤ 29 mL/min without dialysis. 5. Group 5 (Kidney Failure): eGFR \< 15 mL/min and dialysis patients (off-dialysis). 6. Group 6 (Kidney Failure): eGFR \< 15 mL/min and dialysis patients (on-dialysis). Exclusion: * Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase or alanine aminotransferase \> 2 times the upper limit of normal. * Clinically significant hyperkalemia (defined by serum potassium concentration as \> 5.5 mEq/L for Groups 1 to 4, \> 6 mEq/L for Groups 5 and 6) at Screening or Check-in. * History of hypersensitivity, intolerance, or allergy to any drug compound, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor. * Female participants with a positive pregnancy test at Screening or Check-in. * Participant has received a dose of an investigational drug within the past 30 days or 5 halflives, whichever is longer, prior to Check-in. Participants in Group 1 only (participants with normal renal function) are excluded if: • A history of renal disease or renal injury as indicated by medical history or an abnormal renal function profile at Screening or Check-in. Participants in Groups 2 to 6 (participants with varying degrees of renal impairment) are excluded if: • A change in disease status within 30 days of Screening, as documented by the participant's medical history, deemed clinically significant by the Investigator.

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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

  • Advanced Pharma CR, LLC

    Miami, Florida, 33147-4040, United States

  • CRSCA HC LLC, dba Creekside Post Acute

    Yucaipa, California, 92399, United States

  • Clinical Pharmacology Of Miami, LLC

    Miami, Florida, 33014, United States

  • Inland Empire Clinical Trials, LLC

    Rialto, California, 92377-4697, United States

  • Nucleus Network - Minneapolis

    Saint Paul, Minnesota, 55114, United States

  • Orlando Clinical Research Center

    Orlando, Florida, 32809, United States

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