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Experimental shot targets kidney disease at its source

NCT ID NCT05083364

Disease control Sponsor: Arrowhead Pharmaceuticals Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed early-stage trial tested an experimental drug called ARO-C3 in 62 healthy volunteers and patients with two types of kidney disease (C3 glomerulopathy and IgA nephropathy). The drug is designed to calm an overactive part of the immune system that can damage the kidneys. The main goal was to check safety and how the drug moves through the body, with patients receiving three doses over time.

What this could mean

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

Active substance
ARO-C3 (an experimental RNA-targeted drug given by injection under the skin)
What this could lead to
If successful, this could lead to a new treatment option for certain kidney diseases caused by an overactive immune system.
What could go wrong
This is an early-phase trial with only 62 participants, so results may not apply to everyone. The drug is still experimental and may not prove safe or effective in larger 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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

62 people

The number who actually took part.

Started

Feb 2022

Finished

Sep 2025

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 70 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): * Willing to provide written informed consent and to comply with study requirements * Female participants must be non-pregnant/non-lactating * Healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine. C3G and IgAN participants must have been vaccinated or willing to undergo vaccination * All participants must be willing to be vaccinated or have a history of vaccination for Haemophilus influenzae * Body Mass Index (BMI) between 18.0 and 35.0 kg/m2 * 12-lead electrocardiogram (ECG) at Screening with no abnormalities that may compromise participant's safety at discretion of investigator * Participants of childbearing potential must use highly effective contraception during the study and for at least 12 weeks following the end of the study or last dose of study drug, whichever is later. Males must not donate sperm during the study and for at least 12 weeks following the end of the study or last dose of study drug, whichever is later. * No abnormal finding of clinical relevance at the Screening evaluation that, in the opinion of the investigator, could adversely impact participant safety or study results Inclusion Criteria (C3G and IgAN Participants): * Diagnosis of C3G or IgAN * Clinical evidence of ongoing disease based on significant proteinuria * Estimated glomerular filtration rate ≥30 mL/Min/1.73 m2 at Screening and currently not on dialysis * Must be on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) Exclusion Criteria (All Participants): * Seropositive for human immunodeficiency virus (HIV) infection,hepatitis B virus, or hepatitis C virus * History of recurrent or chronic infections * Uncontrolled hypertension * Regular use of alcohol within 30 days prior to Screening * Use of illicit drugs within 1 year prior to Screening or positive urine drug screen at Screening * History of meningococcal infection * History of asplenia or splenectomy * Known contraindication or history of anaphylactic reaction to any vaccine or vaccine component or prophylactic antibiotics planned for use in the study * Any medical or surgical condition that, in the opinion of the investigator, would expose the participant to a significant safety risk or compromise the results of the study Note: Additional Inclusion/Exclusion criteria may apply per protocol

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Conditions

The condition(s) this trial relates to.

complement 3 glomerulopathy IgA glomerulonephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

C3 glomerulopathy IgA nephropathy

Contacts and locations

Locations

  • Research Site

    Auckland, 1010, New Zealand

  • Research Site 1

    Camperdown, New South Wales, 2050, Australia

  • Research Site 1

    Gamcheon, Busan, 49267, South Korea

  • Research Site 2

    Clayton, Victoria, 3168, Australia

  • Research Site 2

    Tbilisi, 0112, Georgia

  • Research Site 2

    Cologne, 50937, Germany

  • Research Site 2

    Haeundae, Busan, 48108, South Korea

  • Research Site 2

    Bangkok, 10400, Thailand

  • Research Site 3

    Concord, New South Wales, 2139, Australia

  • Research Site 3

    Daegu, 42601, South Korea

  • Research Site 3

    Chiang Mai, 50200, Thailand

  • Research Site 4

    Erlangen, 91054, Germany

  • Research Site 4

    Goyang-si, Gyeonggi-do, 10444, South Korea

  • Research Site 4

    Oxford, OX3 7LE, United Kingdom

  • Research Site 6

    Soeul, 03722, South Korea

  • Research Site 8

    Soeul, 05030, South Korea

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