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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00464321
Recruitment Status : Completed
First Posted : April 23, 2007
Last Update Posted : March 19, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE April 20, 2007
First Posted Date  ICMJE April 23, 2007
Last Update Posted Date March 19, 2014
Study Start Date  ICMJE May 2007
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2008)
  • To determine Safety and tolerability of single dose infusions of GC1008 in patients with treatment resistant idiopathic FSGS and nephrotic range proteinuria [ Time Frame: up to 2 years ]
  • Pharmacokinetics of GC1008 following a single dose infusion [ Time Frame: up to 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2007)
  • Safety and tolerability of single dose infusions of GC1008
  • Pharmacokinetics of GC1008 following a single dose infusion
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2008)
To investigate Effect of single dose infusions of GC1008 on biomarkers of clinical efficacy. [ Time Frame: up to 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2007)
Effect of single dose infusions of GC1008 on biomarkers of clinical efficacy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS
Official Title  ICMJE A Phase I, Multicentre, Open-label, Dose-escalating Study of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS)
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 without excessive side effects will be investigated. Tests will determine how long GC1008 is in the body and how it is excreted.
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 cohort have been reviewed by the independent Data Monitoring Committee (DMC). Cohort C and D will run concurrently with patients randomised to receive either a 4 or 0.3 mg/kg body weight dose, respectively. After receiving the infusion of GC1008 on Day 0, patients will be monitored for the 24 hours following the infusion. Patients will return periodically over the following 112 days for safety evaluations and clinical outcome assessments. Blood samples will be collected to evaluate the pharmacokinetics of single dose administration of GC1008 as well as for evaluation of markers of clinical efficacy
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Focal Segmental Glomerulosclerosis
Intervention  ICMJE
  • Biological: GC1008
    1 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
  • Biological: GC1008
    2 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
  • Biological: GC1008
    4 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
  • Biological: GC1008
    0.3 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
Study Arms  ICMJE
  • Experimental: Cohort A
    Dose Group
    Intervention: Biological: GC1008
  • Experimental: Cohort B
    Dose Group
    Intervention: Biological: GC1008
  • Experimental: Cohort C
    Dose Group
    Intervention: Biological: GC1008
  • Experimental: Cohort D
    Dose Group
    Intervention: Biological: GC1008
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2008)
16
Original Enrollment  ICMJE
 (submitted: April 20, 2007)
20
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00464321
Other Study ID Numbers  ICMJE GC1008FSGS00505
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Genzyme, a Sanofi Company )
Study Sponsor  ICMJE Genzyme, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Genzyme, a Sanofi Company
PRS Account Sanofi
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP