Ignite Creation Date:
2024-05-05 @ 9:16 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00856674
Status:
TERMINATED
Last Update Posted:
2010-06-02
First Post:
2009-03-04
Brief Title:
Safety Study of of Intravenous CCL2-LPM in Patients With IgA Nephropathy
Sponsor:
Osprey Pharmaceuticals USA Inc
Organization:
Osprey Pharmaceuticals USA Inc
Study Overview
Official Title:
A Dose-Escalating Phase I Study to Evaluate the Safety Pharmacokinetics and Pharmacodynamics of Intravenous OPL-CCL2-LPM in Patients With IgA Nephropathy
Status:
TERMINATED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to resources and slow enrollment not due to safety
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety of several dose levels of CCL2-LPM in patients with IgA Nephropathy who have high levels of protein in the urine
Detailed Description:
In spite of adequate blood pressure control and diet 30 percent of patients with IgA nephropathy continue to secrete large amounts of protein in the urine and have a high likelihood of progressing to end-stage renal disease over 5-10 years and eventually requiring dialysis or kidney transplant In IgA nephropathy the injured kidney tissue secretes a messenger that recruits white blood cells leukocytes into the kidney This messenger is the chemokine CCL2 As a consequence CCL2 also is excreted into the urine and can be measured as evidence of inflammation in the kidney This study evaluates the safety of a new potential therapyCCL2-LPM leukocyte population modulator for IgA nephropathy CCL2-LPM is composed of the messenger chemokine CCL2 fused to an enzyme that inhibits protein production by the leukocytes and prevents the leukocytes from migrating into the kidney The CCL2 end of the molecule targets only a small subset of leukocytes that have the corresponding receptor for CCL2 on the surface After CCL2 binds to its receptor it is drawn inside the cell and carries the enzyme into the cell The targeted cells are prevented from entering the kidney and causing further damage Thus CCL2-LPM may interrupt the ongoing cycle of inflammation that leads to end-stage renal disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None