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Fake data, real hope: AI could speed up rare disease trials

NCT ID NCT07016282

Knowledge-focused Sponsor: Mario Negri Institute for Pharmacological Research 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at whether artificial intelligence can create realistic, privacy-safe copies of health records from people with a rare kidney disease called ADPKD. Researchers will use these simulated datasets to run virtual clinical trials and see if they produce similar results to real studies. The goal is to make rare disease research faster and more efficient without putting patient data at risk.

What this could mean

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

What this could lead to
If successful, this approach could make it faster and safer to run clinical trials for rare diseases by using simulated data instead of only real patient data.
What could go wrong
This is an early-stage observational study using existing records, not testing a treatment. The simulated data may not perfectly reflect real patient outcomes.

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.

Participants

About 100 people

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

Started

Jun 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Data from ADPKD patients collected in the form of electronic health records (EHR) stored at the Istituto di Ricerche Farmacologiche Mario Negri IRCCS, primarily based on two completed studies performed at the Mario Negri Institue i.e., the ALADIN Study (NCT00309283) and the ALADIN 2 Study (NCT01377246), which enrolled ADPKD-patients treated either with Octreotide-LAR or placebo.

Ages

18 years and older

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: * Adult (\>18 years) men and women with ADPKD according to Ravine criteria25 * Estimated glomerular filtration rate (eGFR) between 15 and 40 mL/min/1.73 m2 (CKD stage: G3b-G4) or higher (CKD stage: G1-G3a), as calculated by the Modification of Diet in Renal Disease study four variables equation Exclusion Criteria: * confounding factors that could affect renal function loss independent of kidney growth and treatment allocation (i.e., diabetes mellitus, urinary protein excretion rate \>3 g/24 h) * Abnormal urinalysis suggestive of concomitant, clinically significant glomerular disease, and urinary tract lithiasis or infection * Patients with major systemic disease * Patients unable to provide informed consent * Pregnant, lactating, or potentially childbearing women without adequate contraception

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Conditions

The condition(s) this trial relates to.

autosomal dominant polycystic kidney disease Rare Diseases

As listed by the trial registrant

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

Autosomal dominant polycystic kidney disease (adpkd)

Contacts and locations

Locations

  • Clinical Research Centre for Rare Diseases Aldo e Cele Daccò

    Ranica, BG, 24020, Italy

  • Department of Global Public Health (GPH), Karolinska Institutet

    Stockholm, 171 77, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.