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New study tests everolimus for kidney tumors in TSC patients

NCT ID NCT05252585

Disease control Sponsor: Novartis 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study looks at how safe and effective the drug everolimus is for Taiwanese adults with tuberous sclerosis complex (TSC) who have kidney tumors called angiomyolipomas. Four participants will take the drug and be monitored for side effects and tumor shrinkage. The goal is to control the disease, not cure it.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

4 people

The number who actually took part.

Started

May 2023

Expected to finish

Oct 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 65 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: 1. Adult male or female patients from ≥ 18 years of age. 2. Signed informed consent must be obtained prior to participation in the study. 3. Participants with TSC associated with renal AML which is eligible for treatment with everolimus per local reimbursement criteria. Exclusion Criteria: 1. Patients with severe hepatic impairment (Child-Pugh class C) 2. Any severe and/or uncontrolled medical conditions. 3. Pregnant or breast-feeding females. 4. Patients with hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients.

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Conditions

The condition(s) this trial relates to.

angiomyolipoma kidney angiomyolipoma tuberous sclerosis tuberous sclerosis 1

As listed by the trial registrant

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

Renal angiomyolipoma

Contacts and locations

Locations

  • Novartis Investigative Site

    Taichung, Taiwan ROC, 40201, Taiwan

  • Novartis Investigative Site

    Taoyuan, Taiwan ROC, 33305, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taoyuan, 33305, Taiwan

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