CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid
Status:
Terminated
Trial end date:
2021-07-02
Target enrollment:
Participant gender:
Summary
Glucocorticoids (GC) use has increased survival of patients with systemic lupus erythematosus
(SLE), particularly in cases of nephritis and a more significant improvement to 80% with the
introduction of therapy combined with immunosuppressants. This therapeutic scheme, however,
results in a very high incidence of irreversible damage that is associated in more than 70%
of the cases to GC use and in a smaller proportion to the use of high dose cyclophosphamide.
CYCLONES is a Controlled Randomized Clinical Trial with the aim of evaluating the efficacy of
a regimen for lupus nephritis treatment using only intravenous corticosteroid administration.
This intravenous corticosteroid regimen has already been tested (with Rituximab instead of
Cyclophosphamide) with high response rates for lupus nephritis and significant reduction of
side effects.
After selection, patients will be randomized in two arms: 116 patients will receive
Euro-Lupus nephritis regimen and other 116 will undergo treatment with CYCLONES regimen.
The primary endpoint is the partial response (protein/creatinine ratio < 3 with decrease at
least of 50% of the initial value and increase of creatinine not higher than 15% of the
initial value) or complete response (protein/creatinine ratio < 500 with decrease at least of
50% of the initial value and increase of creatinine not higher than 15% of the initial value
in 6 months. Secondary outcome measures will be evaluated such as osteoporosis and bone
metabolism parameters, ophthalmologic evaluation of the collateral effects related to
glucocorticoids, lipid profile and therapy adherence.
Phase:
N/A
Details
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo