Renal AngiomyolipomasPhase 2STBETANCT02104011
Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers
A Phase 2 study testing Propranolol in people with Renal Angiomyolipomas and Tuberous Sclerosis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Treatment of angiomyolipomas is based on invasive techniques such as surgery or embolization. Development of anti-angiogenic therapies is a major and growing field of research in hypervascularized tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Angiomyolipomas, Tuberous Sclerosis
- What is being tested?
- Propranolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2015to 22 Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tuberous sclerosis patients with one or several angiomyolipomas of a size of at least 4 cms.
Who cannot join
- Patients whom CT or MR scan shows one or several intra-lesional aneurisms requiring a preventive embolization.
- Patients with a retroperitoneal hemorragic complication requiring a preventive embolization.
- Patients whom biopsy will show an adenocarcinoma, hypertension non controlled, renal failure and severe liver.
- Diabetic subjects insufficiently controlled.
- Beta-blockers contra-indication.
- Psychosis, severe mental disorder.
- Patient already treated with beta-blockers or mTOR inhibitors.
- Pregnant or nursing women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers: Pilot Trial
Treatment of angiomyolipomas is based on invasive techniques such as surgery or embolization. Development of anti-angiogenic therapies is a major and growing field of research in hypervascularized tumors. Angiomyolipomas have been shown to regress after prolonged treatment with mTOR inhibitors (Sirolimus), but with a large proportion of secondary effects. We showed recently that beta-blockers were able to induce regression of infantile hemagiomas. Consequently, we looked for and found, histologically, in a few cases of angiomyolipomas the presence of beta2 receptors.
The aim of the study is to estimate if beta-blockers could induce regression or stabilization of renal angiomyolipomas in tuberous sclerosis in a pilot study.
- Conditions
- Renal Angiomyolipomas, Tuberous Sclerosis
- Being tested
- Propranolol
- Keywords
- Angiomyolipomas in tuberous sclerosis, Beta-blockers, Anti-angiogenic therapies
- Medical subject headings
- Tuberous Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Not described Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of angiomyolipomas volume
Stabilization or even regression of angiomyolipomas volume after 6 months and 1 year of treatment with a quantification of the vascular component.
Measured: 6 months and 1 year after inclusion
Secondary outcomes (4)
Renal function evolution
Improvement of renal function after 6 months and 1 year of treatment
Measured: 6 months and 1 year after inclusion
Effect on the potential haemorraghic transformation
Haemorraghic transformation of angiomyolipomas is diagnosed by Scanner or MRI.
Measured: 6 months and 1 year after inclusion
Improvement of the quality of life
Th evolution of the quality of life is assessed by an EVA scale and by QOL scale.
Measured: 6 months and 1 year after inclusion.
Effect on face angiofibromas
Evolution of the face angiofibromas by a dermatologic assessment.
Measured: 6 months and 1 year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study start22 May 2015
- Primary completion22 Nov 2017
- Study completion22 Nov 2017
Why it stopped: target number of subject not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal AngiomyolipomasStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire RIGOTHIER, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104011
- Sponsor's protocol ID
- CHUBX 2011/35
- Other IDs
- 2013-003477-10
- Acronym
- STBETA
- Status last verified
- Jan 2018
- First submitted
- 1 Apr 2014
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers: Pilot Trial
- ClinicalTrials.gov ID
- NCT02104011
- Acronym / sponsor ID
- STBETA / CHUBX 2011/35
- Conditions
- Renal Angiomyolipomas, Tuberous Sclerosis
- Keywords
- Angiomyolipomas in tuberous sclerosis, Beta-blockers, Anti-angiogenic therapies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: target number of subject not reached
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 22 May 2015 (actual)
- Primary completion
- 22 Nov 2017 (actual)
- Study completion
- 22 Nov 2017 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of angiomyolipomas is based on invasive techniques such as surgery or embolization. Development of anti-angiogenic therapies is a major and growing field of research in hypervascularized tumors. Angiomyolipomas have been shown to regress after prolonged treatment with mTOR inhibitors (Sirolimus), but with a large proportion of secondary effects. We showed recently that beta-blockers were able to induce regression of infantile hemagiomas. Consequently, we looked for and found, histologically, in a few cases of angiomyolipomas the presence of beta2 receptors.
The aim of the study is to estimate if beta-blockers could induce regression or stabilization of renal angiomyolipomas in tuberous sclerosis in a pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Drug: Propranolol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Tuberous sclerosis patients with one or several angiomyolipomas of a size of at least 4 cms.
Key exclusion criteria (8 listed)
- Patients whom CT or MR scan shows one or several intra-lesional aneurisms requiring a preventive embolization.
- Patients with a retroperitoneal hemorragic complication requiring a preventive embolization.
- Patients whom biopsy will show an adenocarcinoma, hypertension non controlled, renal failure and severe liver.
- Diabetic subjects insufficiently controlled.
- Beta-blockers contra-indication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol | Drug | Patient |
Primary outcome
Evolution of angiomyolipomas volume
Time frame: 6 months and 1 year after inclusion
Stabilization or even regression of angiomyolipomas volume after 6 months and 1 year of treatment with a quantification of the vascular component.
4 secondary outcomes
Renal function evolution
Time frame: 6 months and 1 year after inclusion
Effect on the potential haemorraghic transformation
Time frame: 6 months and 1 year after inclusion
Improvement of the quality of life
Time frame: 6 months and 1 year after inclusion.
Effect on face angiofibromas
Time frame: 6 months and 1 year after inclusion
Results and safety
The study was stopped early (reason given: target number of subject not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire RIGOTHIER, Dr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol in people with Renal Angiomyolipomas and Tuberous Sclerosis, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: target number of subject not reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of angiomyolipomas volume (time frame: 6 months and 1 year after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.