GC1008FSGS00505: Phase I, Multicentre, Open-Label, Dose-Escalating, Study of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS

This study is currently recruiting patients.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00464321

Purpose

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.

Condition	Intervention	Phase
Glomerulosclerosis, Focal Segmental	Drug: GC1008, Human Anti-Transforming Growth Factor	Phase 1

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title A Phase I, Multicentre, Open-Label, Dose-Escalating Study of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS)

Further Study Details:
Primary Outcome Measures:
Safety and tolerability of single dose infusions of GC1008
Pharmacokinetics of GC1008 following a single dose infusion

Secondary Outcome Measures:
Effect of single dose infusions of GC1008 on biomarkers of clinical efficacy.

Expected Total Enrollment: 20
Study start: 2007-04

Eligibility

Ages Eligible for Study: 18 Years – 70 Years

Genders Eligible for Study: Both

Criteria

Inclusion Criteria:
18-70 years of age.
GFR≥30ml/min/1.73m2 calculated by the MDRD equation
Urinary total protein: creatinine ratios >300mglmL derived from the average of 2 first morning voids taken during screening period
Biopsy confirmed as idiopathic FSGS by a central reviewer
Treatment resistance
- 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 Criteria:
Secondary FSGS
Steroid resistant patients on >10mg prednisolone or equivalent
Positive serology for serious infections (including but not limited to infection with Hep B or C, HIV, JC, BK)
Concomitant illnesses:
- Diabetes Type I or II
- Cardiac or Hepatic disease, HIV
- Cancer, precancerous state (eg familial adenomatous polyposis)
- Any condition requiring treatment with other immunosuppressant drugs within 4 weeks before enrollment or during the course of the study
Pre-existing oral-pharyngeal disease (dental carries and other minor dental disease are acceptable)
Haemoglobin level of <9.0mg/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 the past 3 months

Location and Contact Information

New York
New Hyde Park, New York, 11042-1433, United States; Recruiting

More Information

Study ID Numbers: GC1008FSGS00505
ClinicalTrials.gov Identifier: NCT00464321
Health Authority: United States: Food and Drug Administration