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Macrophage and monocyte presence in lupus nephritis before and during treatment
EU CTIS ID: 2025-522187-32-01
What this study is testing
Aim 1: Understanding early immunological changes in LN patients (class III/IV+/-V) on a cellular and histopathological level, comparing the CNI voclosporin on top of MMF and prednisolone (triple therapy) to MMF and prednisolone (dual therapy). - Objective 1: determine differences in macrophage clusters in kidney tissue per treatment arm - Objective 2: assess histological response of the addition of intensified treatment (addition of voclosporin) compared to MMF+prednisolone - Objective 3: assess if early histological response is associated with clinical remission after two years and identify innovative early response determinants (including circulating monocyte phenotyping)
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Lupus nephritis patients: Patients with de novo or flaring SLE according to the EULAR/ACR criteria and a suspicion of class III or IV LN with a clinical indication to perform a kidney biopsy. Age 16-70. eGFR as measured by cystatin C must be >20 mL/min.
- SLE patients (disease control group): Diagnosis of SLE according to EULAR/ACR guidelines. Age 16-70.
- Healthy subjects (control group): blank medical history. Age 16-70. A majority (75%) of female healthy subjects wil be sought.
You likely can't join if
- Lupus nephritis patients: LN class I, II or pure class V upon kidney biopsy (in the case of a class I, II or pure V, the patient will be asked consent for analysis of the scRNA-seq data from the kidney biopsy but the patient will not be randomized); eGFR as measured by cystatin C <20 mL/min; Histological chronicity score (NIH) of 8 or higher in the baseline kidney biopsy; Active infection of any kind as evidenced by cultures (blood, urine or otherwise); History of hepatitis B, hepatitis C, tuberculosis and/or HIV; Treatment with any of the following agents within one month before screening: tacrolimus, belimumab, anifrolumab; Treatment with any of the following agents within 6 months before screening: rituximab, daratumumab, eculizumab; Pregnancy; Prolongation of QT-interval (QTc >470ms) and/or bradycardia (resting heart rate <50bpm) measured on two separate occasions; Hyperkalaemia (serum potassium >6.0 mmol/L); Hypertension (blood pressure > 165/105 mmHg, with symptoms of hypertension)*; Co-administration of voclosporin with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
- SLE patients (disease control group): Suspicion of LN; Signs of active infection
- Healthy subjects (control group): signs of active infection
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.