Trial | NCT00856674  Report issue

Title

Safety Study of of Intravenous CCL2-LPM in Patients With IgA Nephropathy
A Dose-Escalating Phase I Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous OPL-CCL2-LPM in Patients With IgA Nephropathy

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    30
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.
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 therapy,CCL2-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 Started
Mar 31
2009
Primary Completion
Jun 30
2010
Anticipated
Study Completion
Jun 30
2010
Anticipated
Last Update
Jun 02
2010
Estimate

Biological OPL-CCL2-LPM

CCL2-LPM intravenous 0.001 mg/kg, 0.01 mg/kg, 0.05 mg/kg, 0.1 mg/kg, 0.5 mg/kg, 1 mg/kg 2 doses one week apart

  • Other names: CCL2-LPM, CCL2-SA1 fusion protein

Criteria 

Inclusion Criteria:

Biopsy proven IgA nephropathy
GFR > 30 mL/min
Urinary protein > 700 mg/day
Stable serum creatinine
Urine CCL2/creatinine > 250 pg/mg
Stable doses of medications
ACEI and/or ARB maximized to control hypertension and proteinuria

Exclusion Criteria:

Other causes of nephropathy
Pregnant or nursing females
Prednisone > 10 mg/day
Other prohibited medications
BP > 140/90
BMI > 35
Concurrent infection requiring treatment
Clinical significant concurrent medical conditions
Known allergy or sensitivity to formulation ingredients
No Results Posted