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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
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 12, 2010
Last Updated
July 5, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Actelion
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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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