- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00856674
Safety Study of of Intravenous CCL2-LPM in Patients With IgA Nephropathy
June 1, 2010 updated by: Osprey Pharmaceuticals USA, Inc.
A Dose-Escalating Phase I Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous OPL-CCL2-LPM in Patients With IgA Nephropathy
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Newfoundland and Labrador
-
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Eastern Health, HSC, Memorial University
-
-
Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Hoptial Maisonneuve-Rosemont
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose limiting toxicity
Time Frame: 30 days after last dose of study drug
|
30 days after last dose of study drug
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics: urine protein/creatinine, urine CCL2/creatinine, sCRP change, change in leukocyte subsets by flow cytometry analysis
Time Frame: over 30 day period
|
over 30 day period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vincent Pichette, M.D., Ph.D., Hopital Maisonneuve-Rosemont, Univeristy of Montreal
- Principal Investigator: Michelle Hladunewich, M.D., Sunnybrook Health Sciences Centre
- Principal Investigator: Bryan Curtis, M.D., Eastern Health, HSC, Memorial University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McDonald JR, McManaman JL, Yong VW. The therapeutic potential of chemokine-toxin fusion proteins. IDrugs. 2001 Apr;4(4):427-42.
- Eardley KS, Zehnder D, Quinkler M, Lepenies J, Bates RL, Savage CO, Howie AJ, Adu D, Cockwell P. The relationship between albuminuria, MCP-1/CCL2, and interstitial macrophages in chronic kidney disease. Kidney Int. 2006 Apr;69(7):1189-97. doi: 10.1038/sj.ki.5000212.
- McIntosh LM, Barnes JL, Barnes VL, McDonald JR. Selective CCR2-targeted macrophage depletion ameliorates experimental mesangioproliferative glomerulonephritis. Clin Exp Immunol. 2009 Feb;155(2):295-303. doi: 10.1111/j.1365-2249.2008.03819.x. Epub 2008 Nov 25.
- Reich HN, Troyanov S, Scholey JW, Cattran DC; Toronto Glomerulonephritis Registry. Remission of proteinuria improves prognosis in IgA nephropathy. J Am Soc Nephrol. 2007 Dec;18(12):3177-83. doi: 10.1681/ASN.2007050526. Epub 2007 Oct 31.
- Morii T, Fujita H, Narita T, Koshimura J, Shimotomai T, Fujishima H, Yoshioka N, Imai H, Kakei M, Ito S. Increased urinary excretion of monocyte chemoattractant protein-1 in proteinuric renal diseases. Ren Fail. 2003 May;25(3):439-44. doi: 10.1081/jdi-120021156.
- Rovin BH. The chemokine network in systemic lupus erythematous nephritis. Front Biosci. 2008 Jan 1;13:904-22. doi: 10.2741/2731.
- Nair R, Walker PD. Is IgA nephropathy the commonest primary glomerulopathy among young adults in the USA? Kidney Int. 2006 Apr;69(8):1455-8. doi: 10.1038/sj.ki.5000292.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Anticipated)
June 1, 2010
Study Completion (Anticipated)
June 1, 2010
Study Registration Dates
First Submitted
March 4, 2009
First Submitted That Met QC Criteria
March 5, 2009
First Posted (Estimate)
March 6, 2009
Study Record Updates
Last Update Posted (Estimate)
June 2, 2010
Last Update Submitted That Met QC Criteria
June 1, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPL01-CCL2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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