Kidney function may change how olpasiran works
NCT ID NCT05489614
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
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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
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Sep 2022
- Finished
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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
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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: * 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
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Advanced Pharma CR, LLC
Miami, Florida, 33147-4040, United States
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CRSCA HC LLC, dba Creekside Post Acute
Yucaipa, California, 92399, United States
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Clinical Pharmacology Of Miami, LLC
Miami, Florida, 33014, United States
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Inland Empire Clinical Trials, LLC
Rialto, California, 92377-4697, United States
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Nucleus Network - Minneapolis
Saint Paul, Minnesota, 55114, United States
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Orlando Clinical Research Center
Orlando, Florida, 32809, United States
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