Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis (GLUREDLUP)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2028
  • participants needed
    30
  • sponsor
    Institutul Clinic Fundeni
Updated on 11 March 2022
corticosteroids
remission
cyclophosphamide
rituximab
treatment regimen
steroid therapy
glomerular filtration rate
prednisolone
azathioprine
mycophenolate
systemic lupus erythematosus
steroid treatment
nephritis

Summary

The aim of the study is to evaluate the efficacy of a therapeutic regimen which decreases glucocorticoid exposure compared with standard therapy in patients with proliferative lupus nephritis during remission induction by evaluating the histological and clinical remission.

Description

After an initial screening phase during which a first kidney biopsy is performed, all patients that meet the inclusion criteria will be randomized to one of the treatment arms:

  • EUROLUPUS regimen: 3 daily pulses of 750 mg of intravenous Methylprednisolone, followed by oral corticosteroid therapy starting with a dose of 0.5 mg / kg / day for 4 weeks, then decreased by 2.5 mg of Prednisolone / day each 2 weeks. A low dose of glucocorticoid (5-7.5 mg / day) is maintained until 24 months after enrollment. All patients will receive Cyclophosphamide intravenously starting day 1, 6 pulses at a fixed dose of 500 mg given at 2 weeks. After 3 months, Azathioprine (2 mg / kg / day) is initiated 2 weeks after the last administration of Cyclophosphamide and maintained for the next 21 months.
  • RITUXILUP regimen: 2 doses of Rituximab 1 g and Methylprednisolone 500 mg on days 1 and 15. Patients will receive Mycophenolate Mofetil, initially 500 mg twice daily, titrated to a maximum of 1.5 g twice daily, depending on leukocyte count and digestive tolerance, which will be maintained 24 months.

Second kidney biopsy will be performed 6 months after the start of the treatment phase.

Details
Condition Lupus Nephritis
Treatment Rituximab, cyclophosphamide, mycophenolate mofetil, Corticosteroids
Clinical Study IdentifierNCT05207358
SponsorInstitutul Clinic Fundeni
Last Modified on11 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age of the patient between 18 and 80 years
Patients diagnosed with systemic lupus erythematosus according to ACR 1997 or SLICC-2012 criteria
Diagnosis of proliferative lupus nephritis class III, IV +/- V (confirmed by renal biopsy and classified according to ISN / RPS)
Estimated glomerular filtration rate by CKD-EPI> 30 ml / min / 1.73 sqm
Estimated glomerular filtration rate by CKD-EPI <30 ml / min / 1.73 sqm but> 15 ml / min / 1.73 sqm with chronicity index (according to NIH score) <6
Absence of contraindications to the use of Methylprednisolone, Mycophenolate mofetil, oral corticosteroids or Rituximab
Ability to provide informed consent

Exclusion Criteria

The patient's age under 18 years
Patients with life-threatening complications (e.g. Cerebritis)
Estimated glomerular filtration rate by CKD-EPI <30 ml / min / 1.73 sqm
Estimated glomerular filtration rate by CKD-EPI <30 ml / min / 1.73 sqm but> 15 ml / min / 1.73 sqm with chronicity index (according to NIH score)> 6
Presence of pregnancy / lactation
Patients who have received more than 2 g of Methylprednisolone intravenously in the last 4 weeks
Use in the last 3 months of biological therapy
Use of intravenous immunoglobulins / plasmapheresis in the last 6 months
The presence of an active infection
History of neoplasia
Comorbidities requiring systemic corticosteroid therapy
Non-adhesion
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