Status:
UNKNOWN
Cyclophosphamide in Lupus Nephritis
Lead Sponsor:
University of Auckland, New Zealand
Collaborating Sponsors:
Auckland District Health Board
Counties Manukau Health
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-80 years
Brief 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. Cy...
Detailed Description
The autoimmune disease systemic lupus erythematosus (SLE) commonly affects the kidneys (lupus nephritis) and for some patients leads to a progressive loss of kidney function. In patients with aggressi...
Eligibility Criteria
Inclusion
- Patients with lupus nephritis requiring therapy with intravenous cyclophosphamide
- Lupus nephritis is defined according to American College of Rheumatology criteria as the presence of either:
- histological evidence from renal biopsy;
- persistent proteinuria of \>0.5 g/day or proteinuria \>3+ on dipstick; or
- cellular casts of any type. Patients will have had a renal biopsy performed to determine the histological class of lupus nephritis. Therapy with cyclophosphamide is typically used in patients with Class III, IV and severe Class V lupus nephritis.
- Patients ≥ 18 years of age
- Patients must be able to provide informed consent
Exclusion
- Those who do not meet inclusion criteria
- Those patients in the retrospective study who have died
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00441220
Start Date
October 1 2006
End Date
October 1 2010
Last Update
March 5 2009
Active Locations (3)
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1
Auckland City Hospital
Auckland, North Island, New Zealand
2
University Of Auckland
Auckland, New Zealand
3
Middlemore Hospital
Manakau, New Zealand, Private Bag 93311