drugset / Trial / NCT00856674
Safety Study of of Intravenous CCL2-LPM in Patients With IgA Nephropathy
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2009-03
- Primary completion
- 2010-06
- Completion
- 2010-06
Outcome
Outcome not reported
Stopped (Enrollment): “Study terminated due to resources and slow enrollment; not due to safety”
Publications
- Background McDonald JR, McManaman JL, Yong VW. The therapeutic potential of chemokine-toxin fusion proteins. IDrugs. 2001 Apr;4(4):427-42.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background Rovin BH. The chemokine network in systemic lupus erythematous nephritis. Front Biosci. 2008 Jan 1;13:904-22. doi: 10.2741/2731.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OPL-CCL2-LPM | Protein / enzyme biologic | 0.001 mg/kg | Intravenous |
| Subject | OPL-CCL2-LPM | Protein / enzyme biologic | 0.01 mg/kg | Intravenous |
| Subject | OPL-CCL2-LPM | Protein / enzyme biologic | 0.05 mg/kg | Intravenous |
| Subject | OPL-CCL2-LPM | Protein / enzyme biologic | 0.1 mg/kg | Intravenous |
| Subject | OPL-CCL2-LPM | Protein / enzyme biologic | 0.5 mg/kg | Intravenous |
| Subject | OPL-CCL2-LPM | Protein / enzyme biologic | 1 mg/kg | Intravenous |