New pill aims to plug kidney leaks in rare disease

NCT ID NCT04456816

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an experimental drug called AP1189 in people with a rare kidney condition called idiopathic membranous nephropathy, which causes severe protein leakage in urine. The trial includes 23 adults who are already on standard blood pressure medications. Participants will receive either AP1189 or a placebo for 12 weeks to see if the drug is safe and can reduce protein loss.

What this could mean

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

Active substance
AP1189
What this could lead to
If successful, AP1189 could offer a new add-on treatment to reduce protein in urine and slow kidney damage in membranous nephropathy patients.
What could go wrong
This is an early Phase 2 trial with only 23 participants, so results may not apply broadly. The drug is added to existing therapy, and its safety and effectiveness are still unproven.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 23 people

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

Started

Aug 2020

Expected to finish

Jun 2026

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 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Written informed consent has been obtained prior to initiating any study-specific procedures * Male and female subjects, 18 to 85 years of age diagnosed with iMN within 6 months prior to inclusion * Diagnosed as anti-PLA2-Receptor positive by local laboratory within 6 months prior to inclusion * Severe proteinuria defined by a U-protein/creatinine ratio \>3.0 g/g and/or U-albumin/creatinine ratio \>2.0 g/g and a P-albumin below the lower normal limit * eGFR \> 30 ml/min/1.73m2 * Treated with ACE- inhibitors or angiotensin II receptor blocker for a minimum of 1 months with a stable systemic arterial blood pressure OR treatment with ACE inhibitors and/or angiotensin receptor blocker was excluded or discontinued due to hypotension, intolerance or other side effect Only Denmark and Norway: * Females of child-bearing potential using reliable means of contraception or are post-menopausal * Females of childbearing potential with negative pregnancy test at screening and baseline Only Sweden: * Post-menopausal women or women who are surgically sterilized. Exclusion Criteria: * Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry * Clinicial findings that in the opinion of the investigator would suggest condition(s) other than iMN as a major cause of severe proteinuria * Major surgery within 8 weeks prior to screening or planned surgery within 1 month following randomization * Blood pressure with systolic pressure above 160 mmHg and/or diastolic pressure above 100 mmHg despite antihypertensive treatment will in all cases be considered "uncontrolled" * Treated with systemic corticosteroids, or other immune suppressive, or immune modulating compounds within 4 weeks prior to screening and during the entire treatment period and until the final visit * Treated with rituximab within 12 months of screening * Evidence of active malignant disease * Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids * Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disease * Pregnant women or nursing mothers * History of alcohol, drug, or chemical abuse within the 6 months prior to screening * Any condition that in the view of the investigator would suggest that the patient is unable to comply with study protocol and procedures Only Sweden: * Females of child-bearing potential.

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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

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aarhus Universitetshospital

    RECRUITING

    Aarhus, 8200, Denmark

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