Status:
COMPLETED
Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Focal Segmental Glomerulosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 wit...
Detailed Description
Patients in each cohort will receive a single dose of GC1008 infusion at 1, 2, 4 or 0.3 mg/kg body weight. The higher dose cohort will not start until the first 28 days safety data for the lower dose ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00464321
Start Date
May 1 2007
End Date
February 1 2010
Last Update
March 19 2014
Active Locations (9)
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1
San Francisco, California, United States
2
Rochester, Minnesota, United States
3
New Hyde Park, New York, United States, 11042-1433
4
Chapel Hill, North Carolina, United States