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Taking people in NetherlandsPhase 4

Voclosporin added to standard treatment for lupus nephritis and its effect on kidney inflammation

Compares voclosporin plus standard drugs with standard drugs alone in lupus nephritis.

Key facts

Who runs it
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Where
Amsterdam, NetherlandsSee the site
Registry 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
Status
Recruiting
Phase
Phase 4
People taking part
55 people, planned
Started
23 Apr 2026
Expected to end
Apr 2030
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Kidney Biopsy
  • Voclosporin (LUPKYNIS)
  • Blood, feces and urine sample collection
  • LupusPRO questionnaire
  • Mycophenolate Mofetil (MMF) Treatment
  • Prednisolone
Record updated
12 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 16-70 with lupus nephritis (lupus kidney disease) who need a kidney biopsy. It also takes people with lupus but no kidney disease, and healthy volunteers, as comparison groups.

Age
16-70 years
Sex
All sexes can join. For healthy volunteers, the trial seeks mostly women (75%).
Disease stage
New or flaring lupus (SLE) with suspected class III or IV lupus nephritis and a clinical reason for a kidney biopsy. Kidney function (eGFR by cystatin C) above 20 mL/min. A separate group has lupus without kidney disease.
Earlier treatment
Cannot have had tacrolimus, belimumab or anifrolumab within 1 month before screening. Cannot have had rituximab, daratumumab or eculizumab within 6 months before screening.

Main reasons for not taking part

  • Lupus nephritis class I, II or pure class V on kidney biopsy
  • Kidney function (eGFR by cystatin C) below 20 mL/min
  • Histological chronicity score (NIH) of 8 or higher on the kidney biopsy
  • Active infection, or a history of hepatitis B, hepatitis C, tuberculosis or HIV
  • Pregnancy

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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
  • 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 16-70
  • Age 16-70
  • 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

Other criteria

  • Lupus nephritis patients

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 16 and 70 years old?

Where in Netherlands

  • Amsterdam UMC StichtingAmsterdam, NetherlandsTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 4 groups in the trial

  • Triple Therapy (MMF + Prednisolone + Voclosporin)Existing treatment, for comparison

    Participants receive induction corticosteroid therapy consisting of intravenous methylprednisolone 500 mg daily for 3 days, followed by oral prednisolone 1 mg/kg/day with tapering to ≤5 mg/day within 3 months, mycophenolate mofetil (MMF) 1000 mg twice daily (or 500 mg four times daily), and voclosporin 23.7 mg twice daily.

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

  • Dual Therapy (MMF + Prednisolone)Existing treatment, for comparison

    Participants receive induction corticosteroid therapy consisting of intravenous methylprednisolone 500 mg daily for 3 days, followed by oral prednisolone 1 mg/kg/day with tapering to ≤5 mg/day within 3 months, and mycophenolate mofetil (MMF) 1000 mg twice daily (or 500 mg four times daily).

    Treatment: Kidney Biopsy, Blood, feces and urine sample collection, LupusPRO questionnaire, Mycophenolate Mofetil (MMF) Treatment, and Prednisolone

  • SLE without LN controlNo study treatment, for comparison

    From the SLE without LN patients (disease control), blood and urine samples are collected at two timepoints, with an interval of (min) 3 and (max) 6 months between collection. Participants in this arm are not randomized and do not undergo treatment or kidney biopsy.

  • Healthy controlNo study treatment, for comparison

    Healthy participants (healthy control) blood and urine samples are collected at two timepoints, with an interval of (min) 3 and (max) 6 months between collection. Participants in this arm are not randomized and do not undergo treatment or kidney biopsy.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Voclosporin added to standard treatment for lupus nephritis and its effect on kidney inflammationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07760480, who can take part
Record updated
12 August 2026