Triple therapy with voclosporin, MMF and prednisolone in lupus nephritis
Official title: 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, an Open Label Randomized Controlled Trial
Run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT07760480 · Data updated 2026-11-12
This trial tests whether adding voclosporin to standard lupus nephritis treatment (MMF and prednisolone) early on improves kidney inflammation compared to standard therapy alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 16 Years to 70 Years |
| Sex | All |
| Enrollment | 55 (estimated) |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | belimumab, anifrolumab, rituximab, daratumumab, eculizumab |
| Locations | 1 site (Amsterdam) |
| Status | Recruiting |
| Started | April 23, 2026 |
| Main results expected | April 2028 |
| Study ends | April 2030 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT07760480 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 16–70 with de novo or flaring SLE and suspected class III or IV lupus nephritis with a clinical indication for kidney biopsy and adequate kidney function.
✕Probably not a fit
Patients with lower kidney function, advanced chronic changes, certain infections, or those on excluded therapies may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with active lupus nephritis will be randomized to receive either triple therapy (MMF, prednisolone, and voclosporin) or the standard MMF plus prednisolone. The study examines how these treatments affect kidney tissue inflammation and macrophage/monocyte populations, and whether blood or urine biomarkers can track disease activity without repeat biopsies. Kidney biopsies, blood, feces, and urine samples, as well as patient-reported outcomes, will be collected to explore early tissue changes and long-term kidney outcomes. The trial aims to identify biomarkers that reflect kidney inflammation and treatment response and to understand the role of immune cells in treatment effects.
Why it matters
Potential benefit: If successful, this approach could lead to faster reduction of kidney inflammation and better long-term kidney outcomes for patients with lupus nephritis.
How similar studies have gone: Prior work suggests immunosuppressive regimens can impact kidney inflammation in LN, but results with triple therapy and biomarker-guided monitoring are still being explored.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Amsterdam University Medical Center
Amsterdam, Netherlands Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.