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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

RecruitingPhase 4Ages 16 Years - 70 YearsAllAcademisch Medisch Centrum - Universiteit van Ams…
NCT07760480 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 res

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📋 Eligibility rules (as published)
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
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What it tests

  • Kidney Biopsy
  • Voclosporin (LUPKYNIS)
  • Blood, feces and urine sample collection
  • LupusPRO questionnaire
  • Mycophenolate Mofetil (MMF) Treatment
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Where

1 site
Amsterdam University Medical Center
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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