Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS

Exclusion Criteria

• •Secondary FSGS
• •steroid resistant patients who are unable to reduce their steroid dose to \<10mg/day of prednisolone or equivalent 4 weeks prior to study dosing day
• •Positive serology for serious infections (including but not limited to infection with Hep B or C, HIV)
• •Concomitant illnesses:Diabetes Type I; Cardiac or Hepatic disease, HIV; Cancer, precancerous state (eg familial adenomatous polyposis; Any condition requiring treatment with other immunosuppressant drugs within 4 weeks prior to dosing day or during the course of the study
• •Pre-existing oral-pharyngeal disease (dental carries and other minor dental disease are acceptable)
• •Haemoglobin level of \<9.0g/dL prior to dosing
• •Treatment with coumadin, anti-vitamin K analogues or low molecular weight heparins. Patients must have stopped treatment a minimum of four weeks prior to receiving study medication.
• •Patients requiring ongoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs). Patients must have stopped treatment a minimum of four weeks prior to receiving study medication.
• •Patients who have had surgery/fracture within 3 months prior to dosing day
• •History of cancer unresolved within 5 years prior to screening or a known precancerous state; or any form of skin cancer either current or past history
• •Women who are pregnant, lactating or who plan to become pregnant within 4 months of infusion
• •Women of childbearing potential unless taking medically acceptable contraceptive
• •Men with female partners of childbearing potential unless they are taking medically acceptable contraceptive precautions
• •Use of any investigation drug administered as part of a clinical trial within 4 weeks prior to commencing screening
• •Other clinically significant, uncontrolled medical condition that in the investigator's opinion may interfere with the assessment or follow-up
• •Active ethanol or drug abuse, excluding tobacco use
• •Electrocardiogram (ECG) abnormalities considered to be clinically significant at screening
• •Unable to comply with the requirements of the study
• •Active thrombophlebitis, thromboembolism, hypercoagulability states, bleeding, or use of anticoagulation therapy (including anti-platelet agents). Patients with a history of deep venous thrombosis may participate if successfully treated, completely resolved, and no treatment has been given for \>4 months.