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

Trial Summary

This study will investigate whether GC1008, an antibody which neutralizes TGF-beta, is safe in treating patients with the disease called focal segmental glomerulosclerosis (FSGS). The highest dose without excessive side effects will be investigated. Tests will determine how long GC1008 is in the body and how it is excreted.

Eligibility

• GFR≥25ml/min/1.73m2 calculated by the MDRD equation
• Urinary total protein: creatinine ratios >200mg/mmol derived from the average of 2
  first morning voids taken during screening period
• Biopsy confirmed as idiopathic FSGS by a central reviewer
• Treatment resistance. NOTE:Patients to have received minimum 6 week course of
  steroids or immunosuppressant
• If receiving treatment with an ACEi and/or ARB dose to be stable for a minimum of 4
  weeks prior to randomization
• Influenza vaccine (according to season)
• Negative screening per American Cancer Society (ACS) 2003 guidelines, as
  appropriate to patient demographics and clinical status

• 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.

Detailed Description

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

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