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| Sponsor: | 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 |
|---|---|---|
|
Focal Segmental Glomerulosclerosis |
Biological: GC1008 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, 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) |
| Enrollment: | 16 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Cohort A: Experimental
Dose Group
|
Biological: GC1008
1 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
|
|
Cohort B: Experimental
Dose Group
|
Biological: GC1008
2 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
|
|
Cohort C: Experimental
Dose Group
|
Biological: GC1008
4 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
|
|
Cohort D: Experimental
Dose Group
|
Biological: GC1008
0.3 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| San Francisco, California, United States | |
| United States, Minnesota | |
| Rochester, Minnesota, United States | |
| United States, New York | |
| New Hyde Park, New York, United States, 11042-1433 | |
| United States, North Carolina | |
| Chapel Hill, North Carolina, United States | |
| Germany | |
| Duesseldorf, Germany | |
| Berlin, Germany | |
| Solingen, Germany | |
| Italy | |
| Bergamo, Italy | |
| United Kingdom | |
| Cambridge, United Kingdom | |
| Study Director: | Medical Monitor | Genzyme |
More Information
| Responsible Party: | Genzyme ( Medical Monitor ) |
| Study ID Numbers: | GC1008FSGS00505, NCT00464321 |
| Study First Received: | April 20, 2007 |
| Last Updated: | October 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00464321 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: MHRA (Medicines & Healthcare products Regulatory Agency); Germany: PEI (Paul-Ehrlich-Institut); Italy: ISS (Istituto Superiore di Sanita) |
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Glomerulosclerosis, Focal Segmental Glomerulonephritis Urologic Diseases Nephritis Kidney Diseases |