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IGA NephropathyPhase 1NCT00856674

Safety Study of of Intravenous CCL2-LPM in Patients With IgA Nephropathy

A Phase 1 study testing OPL-CCL2-LPM in people with IGA Nephropathy and Proteinuria, run by Osprey Pharmaceuticals USA, Inc. at 3 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
IGA Nephropathy, Proteinuria
What is being tested?
OPL-CCL2-LPM
Type of treatment
Injection or infusion
How many people
30 participants
Where
3 sitesCanada
Study dates
Mar 2009to Jun 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Other causes of nephropathy
  • Pregnant or nursing females
  • Prednisone > 10 mg/day
  • Other prohibited medications
  • BP > 140/90
  • BMI > 35
Show all 9Show fewer
  • Concurrent infection requiring treatment
  • Clinical significant concurrent medical conditions
  • Known allergy or sensitivity to formulation ingredients

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Hoptial Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Eastern Health, HSC, Memorial University

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

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
OPL-CCL2-LPM
Keywords
IgA nephropathy, chemokine fusion protein, leukocyte population modulator, phase-1
Medical subject headings
Glomerulonephritis, IGA, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OPL-CCL2-LPMBiological

    Also called CCL2-LPM, CCL2-SA1 fusion protein

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity

    Measured: 30 days after last dose of study drug

Secondary outcomes (1)

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

    Measured: over 30 day period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionJun 2010 (estimated)
  4. Study completionJun 2010 (estimated)

Why it stopped: Study terminated due to resources and slow enrollment; not due to safety

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00856674
Sponsor's protocol ID
OPL01-CCL2
Status last verified
Jun 2010
First submitted
4 Mar 2009
Last updated
2 Jun 2010
Results posted
No
Data monitoring committee
No

Publications

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

    PubMed 16015483

  • 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.

    PubMed 16609683

  • 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.

    PubMed 19040610

  • 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.

    PubMed 17978307

  • 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.

    PubMed 12803507

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

    PubMed 17981599

  • 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.

    PubMed 16531983

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OPL-CCL2-LPM in people with IGA Nephropathy and Proteinuria, run by Osprey Pharmaceuticals USA, Inc. at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated due to resources and slow enrollment; not due to safety). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (time frame: 30 days after last dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00856674, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2010.

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