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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03492255
Date of registration: 16/03/2018
Prospective Registration: Yes
Primary sponsor: University of Sao Paulo General Hospital
Public title: CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid CYCLONES
Scientific title: CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid
Date of first enrolment: April 12, 2018
Target sample size: 232
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03492255
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Brazil
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

All the criteria below have to be completed:

1. Systemic lupus erythematosus (SLE) according to the American College of Rheumatology
(ACR) classification criteria and/or SLICC: according to the thematic protocol (Petri
M, et al., Arthritis Rheum, 2012);

2. Age =18 years;

3. Lupus Glomerulonephritis Class III, IV or V according to the International Society of
Nephrology (ISN)/Renal Pathology Society (RPS) Classification confirmed on renal
biopsy (according to the routine protocol of our outpatient clinic) performed up to 3
months to 1 year prior to selection;

4. Menopause or use contraception method;

5. Informed consent.

Exclusion Criteria:

1. Creatinine clearance < 40 ml/min calculated (Cockcroft & Gault);

2. Intolerance to medication;

3. Absolute neutrophil count < 1,000/mm3;

4. Pregnancy or breastfeeding;

5. Infection requiring hospitalization;

6. Patients who used Cyclophosphamide in the last 6 months or biological in the last
year;

7. Thrombotic renal microangiopathy;

8. Chronic terminal renal disease and/or class VI biopsy;

9. Non-adhesion profile;

10. Need to use another therapeutic scheme;

11. GC dose in the last 3 months not greater than 20mg/day.

11.Central nervous system (CNS) disorders or hemolytic anemia and severe thrombocytopenia
(< 50,000 platelets/mm3).



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Systemic Lupus Erythematosus (SLE)
Intervention(s)
Drug: Cyclophosphamide
Drug: Methylprednisolone
Drug: Mycophenolate Mofetil
Drug: Prednisone
Primary Outcome(s)
Complete renal response [Time Frame: Six months]
Partial renal response [Time Frame: Six months]
Secondary Outcome(s)
Bone structure evaluation [Time Frame: 6 months]
Cataract evaluation [Time Frame: 3 months]
Change from baseline Anti-High-density lipoprotein (anti-HDL) at 6 months [Time Frame: Baseline and 6 months]
Change from baseline High-density lipoprotein (HDL) at 6 months [Time Frame: Baseline and 6 months]
Change from baseline Low-density lipoprotein (LDL) at 6 months [Time Frame: Baseline and 6 months]
Change from baseline Serum levels of prednisone using Area Under the Curve [AUC] at 30 days, 3 months and 6 months [Time Frame: Baseline, 30 days, 3 months and 6 months]
Change from baseline Total cholesterol at 6 months [Time Frame: Baseline and 6 months]
Change from baseline Triglycerides at 6 months [Time Frame: Baseline and 6 months]
Glaucoma evaluation [Time Frame: 15 days, 30 days and 3 months]
Osteoporosis evaluation [Time Frame: 6 months]
Therapy adherence by a self-report medication adherence measure (8-item Morisky Medication Adherence Scale) [Time Frame: Baseline]
Secondary ID(s)
CYCLONES
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Fundação de Amparo à Pesquisa do Estado de São Paulo
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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