Zibotentan Better Renal Scleroderma Outcome Study

Sponsor
University College, London
Study ID
NCT02047708
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zibotentan — DRUG
    Selective endothelin-A antagonist

Study Details

Many patients with scleroderma have damage to their kidneys caused by the disease. There is limited evidence for treatments to prevent this damage or stop it progressing. Blocking a substance in the blood called endothelin has helped treat some aspects of scleroderma. The purpose of this study is to see how effective a new endothelin blocker called Zibotentan is in treating patients who have scleroderma and have gone on to develop reduced kidney function as a complication. It will be given in addition to the accepted treatments used for scleroderma. There will be three parts to this study each for a different group of patients: * ZEBRA 1 for patients with mild or moderate kidney disease caused by scleroderma * ZEBRA 2A for patients with a more severe, acute form of kidney disease caused by scleroderma (scleroderma renal crisis) who do not require dialysis * ZEBRA 2B for patients who have had scleroderma renal crisis and are on dialysis

Key Dates

Start date
Oct 31, 2014
Status verified
Oct 2017
Primary completion
Oct 31, 2017
Completion
Oct 31, 2017

Study Design

Enrollment
27 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

sVCAM 1 soluble Vascular Cell Adhesion Molecule [ Time Frame: 12 months ]

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