NCT07760480RecruitingPhase 4
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
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
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- First submitted
- 7 Jul 2026
- Start date
- Apr 2026
- Primary completion date
- Apr 2028
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Lupus (SLE)
- NCT number
- NCT07760480
- EU CT number
- 2025-522187-32-01
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 55
- From Apr 2026 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Co-administration of voclosporin with strong CYP3A4 inhibitors (e.g., ke toconazole, itraconazole, clarithromycin)
Other illness
- Active infection of any kind as evidenced by cultures (blood, urine or otherwise)
- History of hepatitis B, hepatitis C, tuberculosis and/or HIV
- Hypertension (blood pressure \> 165/105 mmHg, with symptoms of hyperten sion)\*
- 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
- Signs of active infection
- Healthy subjects (control group) Inclusion criteria
- \- Signs of active infection
Lab values
- eGFR as measured by cystatin C \<20 mL/min
- 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)
Age
- Age 16-70
- Age 16-70
Other
- LN class I, II or pure class V upon kidney biopsy
- Histological chronicity score (NIH) of 8 or higher in the kidney biopsy
- Diagnosis of SLE according to EULAR/ACR guidelines
- Suspicion of LN
- Blank medical history
- A majority (75%) of female healthy subjects will be sought
Who the study is looking for
- 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
Criteria the registry did not label
- Lupus nephritis patients
Age in the registry: 16 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.