Safety Study of of Intravenous CCL2-LPM in Patients With IgA Nephropathy

Phase 1

Terminated

• Conditions: IGA Nephropathy; Proteinuria

• Registration Number: NCT00856674
• Lead Sponsor: Osprey Pharmaceuticals USA, Inc.

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 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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-04
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Status Verified: 2010-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-06-01
• Last Update Posted: 2010-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity	30 days after last dose of study drug

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: urine protein/creatinine, urine CCL2/creatinine, sCRP change, change in leukocyte subsets by flow cytometry analysis	over 30 day period

Trial Locations

Locations (3)

Eastern Health, HSC, Memorial University; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Hoptial Maisonneuve-Rosemont; 🇨🇦 Montreal, Quebec, Canada