Scleroderma Renal CrisisPhase 2ScS-REINBONCT01241383
Effect of Bosentan in Scleroderma Renal Crisis
A Phase 2 study testing Bosentan in people with Scleroderma Renal Crisis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Systemic sclerosis (SSc) is a connective tissue disease characterized by excessive collagen deposition, autoimmunity and by vascular hyper-reactivity and obliterative microvascular phenomena that involves multiple organs. Scleroderma Renal Crisis (SRC) occurs in 5% of patients and mainly with diffuse cutaneous SSc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma Renal Crisis
- What is being tested?
- Bosentan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2010to Jun 2016
- 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
- Men or women ≥ 18 years
- Patients had to fulfil ACR and/or LEROY et MEDSGER criteria for systemic sclerosis
- Patients had to fulfil criteria for renal systemic sclerosis
- Written informed consent obtained
Who cannot join
- Scleroderma renal crisis occuring before the age of eighteen
- Patients who are receiving bosentan within one month of inclusion for pulmonary arterial hypertension or digital ulcers prevention
- Other treatment by selective or nonselective antagonist endothelin receptor
- Left ventricle systolic dysfunction (EF < 40 %)
- Patients with systolic blood pressure < 85mm Hg
- Progressive cancer or considered cured for less than 5 years
Show all 12Show fewer
- Patients with a known hypersensitivity to bosentan or any of the excipients
- Patients with HIV, HCV, HBV infection
- Patients with Liver disease Child-Pugh B and C
- Patients who are pregnant or breast-feeding
- Women of child-bearing age who are sexually active without practising reliable methods of contraception
- Patients who do not give informed consent
Trial locations and contacts
1 site in 1 country.
France1 site
Pôle de médecine interne Centre de référence Maladies rares Groupe I Maladies systémiques et maladies auto-immunes rares en particulier Vascularites nécrosantes et les sclérodermies - Hôpital Cochin
Paris, 75014
About this study
Official title: Effect of Bosentan in the Course of Scleroderma Renal Crisis
Systemic sclerosis (SSc) is a connective tissue disease characterized by excessive collagen deposition, autoimmunity and by vascular hyper-reactivity and obliterative microvascular phenomena that involves multiple organs. Scleroderma Renal Crisis (SRC) occurs in 5% of patients and mainly with diffuse cutaneous SSc. The routine use of angiotensin-converting enzyme inhibitors (ACEI) has been reported to dramatically improve outcome, with a fall of the 12-month mortality from 76% to less than 15% in the United-States. Despite prognostic improvement, SRC remains a severe manifestation of SSc and functional outcome and survival remains poor. Bosentan is a specific, orally active, dual endothelin receptor antagonist that has recently been approved for the treatment of primary pulmonary arterial hypertension and for the prevention of ischemic digital ulcers. Bosentan could have therapeutic benefits on others vascular injuries and particularly in SRC.
Read the detailed description
Systemic sclerosis (SSc) is a connective tissue disease characterized by excessive collagen deposition, autoimmunity and by vascular hyper-reactivity and obliterative microvascular phenomena that involves multiple organs. Scleroderma Renal Crisis (SRC) occurs in 5% of patients and mainly with diffuse cutaneous SSc. The routine use of angiotensin-converting enzyme inhibitors (ACEI) has been reported to dramatically improve outcome, with a fall of the 12-month mortality from 76% to less than 15% in the United-States. Despite prognostic improvement, SRC remains a severe manifestation of SSc and functional outcome and survival remains poor. Bosentan is a specific, orally active, dual endothelin receptor antagonist that has recently been approved for the treatment of primary pulmonary arterial hypertension and for the prevention of ischemic digital ulcers. Bosentan could have therapeutic benefits on others vascular injuries and particularly in SRC.
- Conditions
- Scleroderma Renal Crisis
- Being tested
- Bosentan
- Keywords
- Scleroderma renal crisis, angiotensin converting enzyme inhibitors, bosentan, endothelin receptor antagonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosentanDrug
Bosentan 62.5mg bid x 4 weeks; up-titrated to 125mg bid x 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bosentan | Experimental | Bosentan 62.5mg bid x 4 weeks; up-titrated to 125mg bid x 20 weeks Receives: Drug: Bosentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the efficacy of bosentan (Tracleer) in patients with scleroderma renal crisis on renal function
Measured: 6 and 12 months
Secondary outcomes (2)
To evaluate the safety and tolerability of bosentan in patients with scleroderma renal crisis over 6 months of treatment
Measured: 6 months
1 year overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study start6 Dec 2010
- Primary completionOct 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma Renal CrisisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Actelion, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Alice BEREZNE, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241383
- Sponsor's protocol ID
- P081217
- Acronym
- ScS-REINBO
- Status last verified
- Apr 2026
- First submitted
- 12 Nov 2010
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bosentan in the Course of Scleroderma Renal Crisis
- ClinicalTrials.gov ID
- NCT01241383
- Acronym / sponsor ID
- ScS-REINBO / P081217
- Conditions
- Scleroderma Renal Crisis
- Keywords
- Scleroderma renal crisis, angiotensin converting enzyme inhibitors, bosentan, endothelin receptor antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Actelion, URC-CIC Paris Descartes Necker Cochin
- Study start
- 6 Dec 2010 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Nov 2010 (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.
Systemic sclerosis (SSc) is a connective tissue disease characterized by excessive collagen deposition, autoimmunity and by vascular hyper-reactivity and obliterative microvascular phenomena that involves multiple organs. Scleroderma Renal Crisis (SRC) occurs in 5% of patients and mainly with diffuse cutaneous SSc. The routine use of angiotensin-converting enzyme inhibitors (ACEI) has been reported to dramatically improve outcome, with a fall of the 12-month mortality from 76% to less than 15% in the United-States. Despite prognostic improvement, SRC remains a severe manifestation of SSc and functional outcome and survival remains poor. Bosentan is a specific, orally active, dual endothelin receptor antagonist that has recently been approved for the treatment of primary pulmonary arterial hypertension and for the prevention of ischemic digital ulcers. Bosentan could have therapeutic benefits on others vascular injuries and particularly in SRC.
Detailed description
Systemic sclerosis (SSc) is a connective tissue disease characterized by excessive collagen deposition, autoimmunity and by vascular hyper-reactivity and obliterative microvascular phenomena that involves multiple organs. Scleroderma Renal Crisis (SRC) occurs in 5% of patients and mainly with diffuse cutaneous SSc. The routine use of angiotensin-converting enzyme inhibitors (ACEI) has been reported to dramatically improve outcome, with a fall of the 12-month mortality from 76% to less than 15% in the United-States. Despite prognostic improvement, SRC remains a severe manifestation of SSc and functional outcome and survival remains poor. Bosentan is a specific, orally active, dual endothelin receptor antagonist that has recently been approved for the treatment of primary pulmonary arterial hypertension and for the prevention of ischemic digital ulcers. Bosentan could have therapeutic benefits on others vascular injuries and particularly in SRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bosentan | Experimental | Drug: BosentanBosentan 62.5mg bid x 4 weeks; up-titrated to 125mg bid x 20 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women ≥ 18 years
- Patients had to fulfil ACR and/or LEROY et MEDSGER criteria for systemic sclerosis
- Patients had to fulfil criteria for renal systemic sclerosis
- Written informed consent obtained
Key exclusion criteria (12 listed)
- Scleroderma renal crisis occuring before the age of eighteen
- Patients who are receiving bosentan within one month of inclusion for pulmonary arterial hypertension or digital ulcers prevention
- Other treatment by selective or nonselective antagonist endothelin receptor
- Left ventricle systolic dysfunction (EF < 40 %)
- Patients with systolic blood pressure < 85mm Hg
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 |
|---|---|---|
| BosentanBosentan 62.5mg bid x 4 weeks; up-titrated to 125mg bid x 20 weeks | Drug | Bosentan |
Primary outcome
To explore the efficacy of bosentan (Tracleer) in patients with scleroderma renal crisis on renal function
Time frame: 6 and 12 months
2 secondary outcomes
To evaluate the safety and tolerability of bosentan in patients with scleroderma renal crisis over 6 months of treatment
Time frame: 6 months
1 year overall survival
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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.
Alice BEREZNE, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Bosentan in people with Scleroderma Renal Crisis, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 1 May 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To explore the efficacy of bosentan (Tracleer) in patients with scleroderma renal crisis on renal function (time frame: 6 and 12 months). 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 1 May 2026.