Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis

Last updated: March 2, 2022
Sponsor: Institutul Clinic Fundeni
Overall Status: Active - Recruiting

Phase

4

Condition

Lupus Nephritis

Kidney Disease

Nephritis

Treatment

N/A

Clinical Study ID

NCT05207358
FundeniCI
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age of the patient between 18 and 80 years,
  • Patients diagnosed with systemic lupus erythematosus according to ACR 1997 orSLICC-2012 criteria
  • Diagnosis of proliferative lupus nephritis class III, IV +/- V (confirmed by renalbiopsy 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

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 thelast 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

Study Design

Total Participants: 30
Study Start date:
March 02, 2022
Estimated Completion Date:
December 31, 2028

Study 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

    1. 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.

Connect with a study center

  • Fundeni Clinical Institute

    Bucharest, 022328
    Romania

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.