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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2005-000701-61-GB |
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Date of registration:
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27/10/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An open label trial of the dual specificity endothelin receptor antagonist bosentan in established scleroderma renal crisis - BIRD-1
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Scientific title:
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An open label trial of the dual specificity endothelin receptor antagonist bosentan in established scleroderma renal crisis - BIRD-1 |
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Date of first enrolment:
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29/11/2005 |
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Target sample size:
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15 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000701-61 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other: yes
Other specify the comparator: Historical controls
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV):
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Countries of recruitment
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients with scleroderma renal crisis, requiring both of
1. New onset blood pressure >150/80 obtained twice over a 24 hour period
2. A documented decrease in renal function of at least 30% in the calculated glomerular filtration rate.
Patients with diffuse or limited systemic sclerosis of any disease duration
Age 18 or older
Women must be postmenopausal, surgically or naturally sterile, or use a reliable form of contraception during study treatment during and for three months after completion of the study. Hormone based contraception alone are not regarded as a reliable form of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Previous use of an endothelin receptor antagonist
Significant baseline abnormalities in liver function testing (biochemical markers more than 3 times upper limit of normal)
Patients with moderate or severe hepatic impairment i.e. Child-Pugh class B or C
Patients with body weight <40kg
Patients with a systolic blood pressure <85 mm Hg
Patients with conditions that prevent compliance with the protocol or failure to adhere to therapy
Patients with any other life threatening condition.
Patients with known hypersensitivity to bosentan, or any of the excipients of the formulation.
Patients receiving glibenclamide, cyclosporin A, or tacrolimus within 1 week prior to screening, or expecting to receive any of these agents during the study.
Patients who have received an investigational agent in the month preceding screening.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Scleroderma renal crisis
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Intervention(s)
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Trade Name: Tracleer
Product Name: Bosentan
Product Code: N/A
Pharmaceutical Form: Film-coated tablet
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Primary Outcome(s)
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Primary end point(s): Creatinine clearance - baseline, minimum and at 6 and 12 months
24hr urinary protein - baseline, minimum and at 6 and 12 month
Serum creatinine - baseline, minimum and at 6 and 12 months
Dialysis duration
Time to achieve control of hypertension
Maintenance anti-hypertensive therapy at 6 and 12 months (number of anti-hypertensives)
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Secondary Objective: To assess any difference in outcomes of those patients commenced on treatment within 10 days of onset of scleroderma renal crisis, compared with those treated later.
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Main Objective: To assess efficacy, safety and tolerability of treating scleroderma renal crisis with bosentan.
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Secondary ID(s)
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BIRD-1 250705
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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