Effect of Bosentan in Scleroderma Renal Crisis (ScS-REINBO)
Primary Purpose
Scleroderma Renal Crisis
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Bosentan
Sponsored by
About this trial
This is an interventional treatment trial for Scleroderma Renal Crisis focused on measuring Scleroderma renal crisis, angiotensin converting enzyme inhibitors, bosentan, endothelin receptor antagonist
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- 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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bosentan
Arm Description
Bosentan 62.5mg bid x 4 weeks; up-titrated to 125mg bid x 20 weeks
Outcomes
Primary Outcome Measures
To explore the efficacy of bosentan (Tracleer) in patients with scleroderma renal crisis on renal function
Secondary Outcome Measures
To evaluate the safety and tolerability of bosentan in patients with scleroderma renal crisis over 6 months of treatment
1 year overall survival
Full Information
NCT ID
NCT01241383
First Posted
November 12, 2010
Last Updated
July 5, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Actelion
1. Study Identification
Unique Protocol Identification Number
NCT01241383
Brief Title
Effect of Bosentan in Scleroderma Renal Crisis
Acronym
ScS-REINBO
Official Title
Effect of Bosentan in the Course of Scleroderma Renal Crisis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Actelion
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma Renal Crisis
Keywords
Scleroderma renal crisis, angiotensin converting enzyme inhibitors, bosentan, endothelin receptor antagonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bosentan
Arm Type
Experimental
Arm Description
Bosentan 62.5mg bid x 4 weeks; up-titrated to 125mg bid x 20 weeks
Intervention Type
Drug
Intervention Name(s)
Bosentan
Intervention Description
Bosentan 62.5mg bid x 4 weeks; up-titrated to 125mg bid x 20 weeks
Primary Outcome Measure Information:
Title
To explore the efficacy of bosentan (Tracleer) in patients with scleroderma renal crisis on renal function
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
To evaluate the safety and tolerability of bosentan in patients with scleroderma renal crisis over 6 months of treatment
Time Frame
6 months
Title
1 year overall survival
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice BEREZNE, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
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Effect of Bosentan in Scleroderma Renal Crisis
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