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CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid

NCT03492255

NAINTERVENTIONAL
University of Sao Paulo General Hospital
49 participants
Started 2018-04-12 · Completed 2021-07-02
Status: Terminated (as of 12-23-2025)

Conditions

Systemic Lupus Erythematosus (SLE)

Linked Papers (from SciSciNet-V2)

Total Papers16
Background
4
Result
0
Derived
0
Unknown
12

Total Citations Per Year

Brief 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.

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Unknown Papers12

Immunosuppressive therapy in lupus nephritis: The Euro‐Lupus Nephritis Trial, a randomized trial of low‐dose versus high‐dose intravenous cyclophosphamide
2002
999 citations
Sequential Therapies for Proliferative Lupus Nephritis
2004
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The reliability of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index in patients with Systemic Lupus Erythematosus
1997
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Prospective observational single-centre cohort study to evaluate the effectiveness of treating lupus nephritis with rituximab and mycophenolate mofetil but no oral steroids
2013
409 citations
Accrual of organ damage over time in patients with systemic lupus erythematosus.
2003
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A Randomized, Multicenter Study of Steroid Avoidance, Early Steroid Withdrawal or Standard Steroid Therapy in Kidney Transplant Recipients
2008
304 citations
Classification and definition of major flares in SLE clinical trials
1999
248 citations
Glucocorticoid use and abuse in SLE
2012
212 citations
Restrictive Use of Oral Glucocorticoids in Systemic Lupus Erythematosus and Prevention of Damage Without Worsening Long‐Term Disease Control: An Observational Study
2017
83 citations
Pharmacokinetics of Methylprednisolone and Prednisolone After Single and Multiple Oral Administration
1997
63 citations
Limited duration of the effect of methylprednisolone on changes on MRI in multiple sclerosis
1994
57 citations
Short-term high dose steroid therapy does not affect the hypothalamic-pituitary-adrenal axis in relapsing multiple sclerosis patients. Clinical assessment by the insulin tolerance test
1996
34 citations