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Cyclophosphamide in Lupus Nephritis

NCT00441220 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2009-03-05

No results posted yet for this study

Summary

Cyclophosphamide is widely used in the treatment of cancer and autoimmune diseases such as lupus nephritis. However, there is considerable variability in the response to cyclophosphamide treatment. Cyclophosphamide is a pro-drug that requires initial activation by CYP liver enzymes. Recent clinical studies have indicated a possible role of one CYP enzyme, CYP2C19 in this activation step. This enzyme has a genetic polymorphism (variants which lack functional activity) and people who have inherited these variants are poor metabolisers of certain drugs.

The aim of this study is to determine whether response to therapy in a New Zealand population of lupus nephritis patients is determined by cyclophosphamide bioactivation (the metabolic phenotype) and CYP genotype.

Currently there is no way of predicting a patient's response to cyclophosphamide. An understanding of the factors which contribute to the therapeutic failure in lupus nephritis is particularly important due to the high morbidity and mortality associated with this disease. There are other treatment options for lupus nephritis patients who fail to respond to cyclophosphamide. If successful, this study may help identify patients who are unlikely to respond to cyclophosphamide and thus should not be unnecessarily be exposed to the drug and may justify the use of newer, more costly immunosuppressive drugs such as mycophenolate mofetil and rituximab.

Conditions

Sponsors & Collaborators

  • Auckland District Health Board

    collaborator OTHER_GOV

  • Counties Manukau Health

    collaborator OTHER

  • Auckland Medical Research Foundation

    collaborator OTHER

  • Arthritis New Zealand

    collaborator OTHER

  • University of Auckland, New Zealand

    lead OTHER

Principal Investigators

  • Nuala Helsby, PhD · Senior Lecturer in Molecular Medicine and Pathology, University of Auckland

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Completion
2010-10-31

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00441220 on ClinicalTrials.gov