Kidney-Friendly? early study checks hepatitis d drug in patients with impaired kidneys
NCT ID NCT05760300
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage study looked at how the drug bulevirtide behaves in people with chronic hepatitis D who also have normal or impaired kidney function. Researchers measured drug levels in the blood, its effect on bile acids, and overall safety. The study enrolled 41 adults and gave them multiple doses of bulevirtide by injection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bulevirtide (also known as Hepcludex or Myrcludex B)
- What this could lead to
- If successful, this study could help doctors understand how to safely use bulevirtide in hepatitis D patients with kidney issues.
- What could go wrong
- This is a very early (Phase 1) study with only 41 people. It focuses on drug levels and safety, not on curing hepatitis D. Results may not apply to all patients.
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
-
41 people
The number who actually took part.
- Started
-
Mar 2023
- Finished
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Jul 2024
- 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 79 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.
Key Inclusion Criteria: All Individuals: * Body mass index (BMI) of at least ≥ 18.0 kg/m\^2 and ≤ 40.0 kg/m\^2 at screening. * No clinically significant abnormalities on electrocardiogram (ECG) * No known Liver Disease (Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)) ≤ 3 x upper limit of normal (ULN) at screening. Individuals with Renal Impairment (RI): * Have RI classification at screening that has been unchanged during the 90 days prior to study drug dosing. * Estimated Glomerular Filtration Rate (eGFR) must be the following (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Inker 2021)) based on serum creatinine as measured at the screening evaluation: * Severe RI (Groups A and B): eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2 * Moderate RI (Group C): eGFR ≥ 30 to ≤ 59 mL/min/1.73 m\^2 * Mild RI (Group D): eGFR ≥ 60 to ≤ 89 mL/min/1.73 m\^2 * Hemoglobin ≥ 9 g/dL at screening. * Individuals with cardiovascular disease, hypertension, diabetes mellitus, hyperlipidemia, hypothyroidism, osteoporosis, and many others) may be included provided that these diseases/conditions are clinically stable. Matched Control Individuals: * Have an eGFR of at least 90 mL/min/1.73 m\^2 (using the CKD-EPI equation) based on serum creatinine as measured at screening evaluation. * Matched for sex, age (± 10 years), and BMI (± 20%, 18.0 ≤ BMI ≤ 40.0 kg/m\^2) with the respective participant in the RI group. Key Exclusion Criteria: All Individuals: * Positive human immunodeficiency virus (HIV) test, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody with detectable HCV viral ribonucleic acid (RNA) at screening. * Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with participant treatment, assessment, or compliance with the protocol. Individuals with RI: * Recent history of reception of any blood or blood products or history of major bleeding within 4 weeks of dosing. * Positive test for drugs of abuse, including alcohol at screening or admission, with the exception of opioids and tetrahydrocannabinol (THC, marijuana) under prescription and verified by the investigator as for pain management. * Received treatment with trimethoprim or cimetidine or tenofovir prodrugs (tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF)) (affects elimination of creatinine) or with competitors of renal tubular excretion (eg, probenecid, chronic high-dose nonsteroidal anti-inflammatory drugs) within 28 days of Day -1. * Received known nephrotoxic drugs (eg, aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, pentamidine, cyclosporine, tacrolimus, herbal remedies (eg, compounds with aristolochic acid)) within 28 days of Day -1. * Individuals requiring or anticipated to require dialysis within 90 days of study entry. * Serum albumin concentration \<25 g/L. * Uncontrolled treated/untreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg); current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg). Matched Control Individuals: * Have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins Note: 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.
Contacts and locations
Locations
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Advanced Pharma CR, LLC
Miami, Florida, 33147, United States
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Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014, United States
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Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016, United States
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Genesis Clinical Research, LLC
Tampa, Florida, 33603, United States
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Global Clinical Professionals Research
St. Petersburg, Florida, 33705, United States
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Massachusetts General Hospital - Renal Associates Clinic
Boston, Massachusetts, 02114, United States
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Nucleus Network
Saint Paul, Minnesota, 55114, United States
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Panax Clinical Research
Miami Lakes, Florida, 33014, United States
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Velocity Clinical Research, New Smyrna Beach
Edgewater, Florida, 32132, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a daily pill tame hepatitis d?
- New combo therapy aims to clear hepatitis b and d in 20-patient trial
- New antibody could tame dual hepatitis b and d infection
- New hope for hepatitis d: libevitug enters final testing phase
- New hope for hepatitis delta: phase 3 trial of brelovitug launches
- Liver drug bulevirtide tested in people with liver problems