NCT07760480 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
| NCT ID | NCT07760480 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Lupus Nephritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2026-04-23 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 55 participants in total. It began in 2026-04-23 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn how different treatments affect immune cells in the kidney in people with active lupus nephritis (LN), a kidney manifestation of systemic lupus erythematosus (SLE). It will also investigate whether early changes in kidney tissue can predict long-term treatment response and whether blood or urine biomarkers can be used to monitor disease activity without the need for repeat kidney biopsies. The main questions it aims to answer are: * Does adding voclosporin to standard treatment with mycophenolate mofetil (MMF) and prednisolone result in greater early improvement of kidney inflammation compared with MMF and prednisolone alone? * Are specific macrophage and monocyte populations associated with treatment response and long-term kidney outcomes? * Can blood- or urine-based biomarkers be identified that reflect kidney inflammation and treatment response? Researchers will compare MMF, prednisolone, and voclosporin (triple therapy) with MMF and prednisolone alone (dual therapy) to determine whether intensified treatment leads to faster and more complete immunological and histological remission. Participants with newly diagnosed or relapsing proliferative lupus nephritis will: * Be randomly assigned to receive either triple therapy (MMF, prednisolone, and voclosporin) or dual therapy (MMF and prednisolone). * Undergo a kidney biopsy before treatment starts and a repeat kidney biopsy after 3 months of treatment. * Provide blood and urine samples during follow-up for immune cell analyses and biomarker studies. * Complete patient-reported outcomes questionnaires * Attend regular study visits and clinical assessments for up to 2 years. In addition, participants with SLE without lupus nephritis and healthy volunteers will provide blood samples to allow comparison of circulating immune cell populations between groups.
Eligibility Criteria
Lupus nephritis patients Inclusion Criteria: * 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 years * eGFR as measured by cystatin C \>20 mL/min Exclusion Criteria: * LN class I, II or pure class V upon kidney biopsy * eGFR as measured by cystatin C \<20 mL/min * Histological chronicity score (NIH) of 8 or higher in the 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 * 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 hyperten sion)\* * Co-administration of voclosporin with strong CYP3A4 inhibitors (e.g., ke toconazole, itraconazole, clarithromycin) * Pregnancy * A single elevated blood pressure measurement will not lead to immediate exclusion from the trial. Antihypertensive therapy may be initiated as appropriate. Dose adjustments of voclosporin should be made in accordance with Section 11.3.2 of the protocol SLE patients without LN (disease control group) Inclusion criteria * Diagnosis of SLE according to EULAR/ACR guidelines * Age 16-70 Exclusion criteria * Suspicion of LN * Signs of active infection Healthy subjects (control group) Inclusion criteria * Blank medical history * Age 16-70 * A majority (75%) of female healthy subjects will be sought Exclusion criteria \- Signs of active infection
Frequently Asked Questions
Who can join the NCT07760480 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 70 Years, studying Lupus Nephritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07760480 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07760480 currently recruiting?
Yes, NCT07760480 is actively recruiting participants. Visit ClinicalTrials.gov or contact Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) to inquire about joining.
Where is the NCT07760480 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT07760480 clinical trial?
NCT07760480 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial plans to enroll 55 participants.
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