Scleroderma renal crisis
Conditions
Interventions
Trade Name: Tracleer
Product Name: Bosentan
Product Code: N/A
Pharmaceutical Form: Film-coated tablet
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy, safety and tolerability of treating scleroderma renal crisis with bosentan.;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.; 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) | — |
Countries
United Kingdom
Outcome results
None listed