Study Comparing Kidney Inflammation and Immune Cell Changes in Lupus Nephritis Patients Treated with Mycophenolate Mofetil, Prednisolone, and Voclosporin Versus Mycophenolate Mofetil and Prednisolone Alone

What this Trial Is About

Researchers are studying lupus nephritis LN, a kidney condition linked to systemic lupus erythematosus SLE, to understand how different treatments affect immune cells in the kidney. This trial aims to find out if adding voclosporin to standard treatment with mycophenolate mofetil MMF and prednisolone leads to faster reduction of kidney inflammation. They also want to see if specific immune cell types relate to treatment response and if blood or urine markers can monitor disease activity without repeat biopsies. Participants with newly diagnosed or relapsing proliferative LN will be randomly assigned to receive either triple therapy MMF, prednisolone, and voclosporin or dual therapy MMF and prednisolone. Both groups will start with intravenous methylprednisolone for 3 days, followed by oral prednisolone tapered over 3 months and MMF at specified doses. Kidney biopsies will be done before treatment and again after 3 months. Additional groups include SLE patients without LN and healthy volunteers who will provide blood and urine samples but will not receive treatment or biopsies. Participants will attend regular study visits up to 2 years for clinical assessments and sample collections. Blood, urine, and feces samples will be collected to analyze immune cells and biomarkers. Patients will also complete the lupusPRO questionnaire on quality of life. The main measure is to compare immune cell differences in kidney tissue after 3 months between treatment groups. Secondary measures include clinical remission by proteinuria, histological response, and identification of non-invasive biomarkers throughout follow-up.

Assessing Residual Inflammation and Macrophage Presence in Lupus Nephritis After 3 Months of Intensified Treatment With Prednisolone, Mycofenolate Mofetil and Voclosporin as Compared to Mycofenolate Mofetil and Prednisolone