Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05207358
Study type Interventional
Source Institutul Clinic Fundeni
Contact Bogdan Obrisca, MD, PhD
Phone 0040721256797
Email obriscabogdan@yahoo.com
Status Recruiting
Phase Phase 4
Start date March 2, 2022
Completion date December 31, 2028

See also
  Status Clinical Trial Phase
Recruiting NCT02936375 - The Iguratimod Effect on Lupus Nephritis (IGeLU) Phase 2
Completed NCT03597464 - Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin Phase 3
Recruiting NCT01226147 - Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis Phase 2
Completed NCT01206569 - Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis Phase 4
Active, not recruiting NCT00569101 - A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis Phase 2
Terminated NCT00368264 - TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL ) Phase 2/Phase 3
Completed NCT00298506 - Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V) N/A
Completed NCT00371319 - Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis Phase 4
Completed NCT00094380 - Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077) Phase 1/Phase 2
Terminated NCT04376827 - A Study of Guselkumab in Participants With Active Lupus Nephritis Phase 2
Completed NCT03610516 - Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis. Phase 2
Recruiting NCT03526042 - Angiotensin-II Receptor Antibodies Blockade With Losartan in Patients With Lupus Nephritis N/A
Withdrawn NCT03859570 - Pentoxifylline in Lupus Nephritis Phase 4
Completed NCT03664908 - Detection of Anti-glomerular Basement Membrane Antibodies (Anti-GBM): a Promising Biomarker for Lupus Nephritis (LN)? N/A
Completed NCT01085097 - A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis Phase 2
Active, not recruiting NCT05704088 - SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Lupus Nephritis Patients Phase 4
Not yet recruiting NCT06429800 - A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Lupus Nephritis Phase 1
Recruiting NCT02226341 - ACTHar in the Treatment of Lupus Nephritis Phase 4
Recruiting NCT02453997 - Mycophenolic Acid Pharmacokinetics and Pharmacogenomics in Lupus Nephritis N/A
Completed NCT01470183 - Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients N/A