NCT00856674

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 2, 2010

Status Verified

June 1, 2010

Enrollment Period

1.3 years

First QC Date

March 4, 2009

Last Update Submit

June 1, 2010

Conditions

IGA NephropathyProteinuria

Keywords

IgA nephropathychemokine fusion proteinleukocyte population modulatorphase-1

Outcome Measures

Primary Outcomes (1)

  • Dose limiting toxicity

    30 days after last dose of study drug

Secondary Outcomes (1)

  • Pharmacokinetics: urine protein/creatinine, urine CCL2/creatinine, sCRP change, change in leukocyte subsets by flow cytometry analysis

    over 30 day period

Interventions

OPL-CCL2-LPMBIOLOGICAL

CCL2-LPM intravenous 0.001 mg/kg, 0.01 mg/kg, 0.05 mg/kg, 0.1 mg/kg, 0.5 mg/kg, 1 mg/kg 2 doses one week apart

Also known as: CCL2-LPM, CCL2-SA1 fusion protein

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Eastern Health, HSC, Memorial University

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Hoptial Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (7)

  • McDonald JR, McManaman JL, Yong VW. The therapeutic potential of chemokine-toxin fusion proteins. IDrugs. 2001 Apr;4(4):427-42.

    PMID: 16015483BACKGROUND

  • 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.

    PMID: 16609683BACKGROUND

  • 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.

    PMID: 19040610BACKGROUND

  • 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.

    PMID: 17978307BACKGROUND

  • 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.

    PMID: 12803507BACKGROUND

  • Rovin BH. The chemokine network in systemic lupus erythematous nephritis. Front Biosci. 2008 Jan 1;13:904-22. doi: 10.2741/2731.

    PMID: 17981599BACKGROUND

  • 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.

    PMID: 16531983BACKGROUND

MeSH Terms

Conditions

Glomerulonephritis, IGAProteinuria

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 6, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 2, 2010

Record last verified: 2010-06

Locations

CA(3)