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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00856674 |
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Date of registration:
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04/03/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety Study of of Intravenous CCL2-LPM in Patients With IgA Nephropathy
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Scientific title:
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A Dose-Escalating Phase I Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous OPL-CCL2-LPM in Patients With IgA Nephropathy |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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30 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00856674 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Canada
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Contacts
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Name:
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Bryan Curtis, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eastern Health, HSC, Memorial University |
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Name:
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Vincent Pichette, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Maisonneuve-Rosemont, Univeristy of Montreal |
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Name:
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Michelle Hladunewich, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sunnybrook Health Sciences Centre |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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IGA Nephropathy
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Proteinuria
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Intervention(s)
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Biological: OPL-CCL2-LPM
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Primary Outcome(s)
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Dose limiting toxicity
[Time Frame: 30 days after last dose of study drug]
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Secondary Outcome(s)
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Pharmacokinetics: urine protein/creatinine, urine CCL2/creatinine, sCRP change, change in leukocyte subsets by flow cytometry analysis
[Time Frame: over 30 day period]
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Secondary ID(s)
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OPL01-CCL2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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