Status:
TERMINATED
Safety Study of of Intravenous CCL2-LPM in Patients With IgA Nephropathy
Lead Sponsor:
Osprey Pharmaceuticals USA, Inc.
Conditions:
IGA Nephropathy
Proteinuria
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00856674
Start Date
March 1 2009
End Date
June 1 2010
Last Update
June 2 2010
Active Locations (3)
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1
Eastern Health, HSC, Memorial University
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
3
Hoptial Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4