Lupus NephritisPhase 4MAPLENCT07760480
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
A Phase 4 study testing Kidney Biopsy, Voclosporin (LUPKYNIS) and Blood, feces and urine sample collection in people with Lupus Nephritis and Systemic Lupus Erythematosus (SLE), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lupus Nephritis, Systemic Lupus Erythematosus (SLE)
- What is being tested?
- Kidney Biopsy, Voclosporin (LUPKYNIS) and Blood, feces and urine sample collection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Apr 2026to Apr 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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 join
- 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:
Show all 23Show fewer
- 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
- 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
- Signs of active infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Center
Amsterdam
Marc L Hilhorst, Principal Investigator, +31205669111, m.l.hilhorst@amsterdamumc.nl
Marc L Hilhorst, MD, PhD
About this study
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
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:
Read more
- 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.
- Being tested
- Kidney Biopsy, Voclosporin (LUPKYNIS), Blood, feces and urine sample collection, LupusPRO questionnaire, Mycophenolate Mofetil (MMF) Treatment
- Keywords
- Lupus Nephritis, LN, SLE, Systemic lupus erythematosus, volcosporin, mmf, cellcept, prednisolone, kidney biopsy
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney BiopsyProcedure or surgery
At 3 months after the start of treatment, participants will undergo a repeat renal biopsy for assessment of early histological response and for single-cell RNA sequencing.
Voclosporin (LUPKYNIS)Drug
Arm 1 will receive triple therapy (addition of voclosporin)
Blood, feces and urine sample collectionDiagnostic test
Blood, feces and urine samples will be collected at multiple timepoints during study follow-up period.
LupusPRO questionnaireOther
The lupusPRO v1.7 questionnaire (20) is a 43-question patient reported outcome survey tool to follow the impact of lupus or its treatment on the patient's quality of life. The questionnaire takes 7-8 minutes to complete and is validated and available in multiple languages. Participants will be asked to either fill in the questionnaire at home (and bring it on their next outpatient clinic visit) or while visiting the hospital during follow-up time. The questionnaires are filled in on paper.
Mycophenolate Mofetil (MMF) TreatmentDrug
MMF 1000 mg twice daily (or 500 mg four times daily)
PrednisoloneDrug
Following intravenous methylprednisolone induction (500mg, 3 days), oral prednisolone 1 mg/kg/day tapered to ≤5 mg/day within 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Triple Therapy (MMF + Prednisolone + Voclosporin) | Active comparator | 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. Receives: Procedure: Kidney Biopsy; Drug: Voclosporin (LUPKYNIS); Diagnostic Test: Blood, feces and urine sample collection; Other: LupusPRO questionnaire; Drug: Mycophenolate Mofetil (MMF) Treatment; Drug: Prednisolone |
| Dual Therapy (MMF + Prednisolone) | Active comparator | 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). Receives: Procedure: Kidney Biopsy; Diagnostic Test: Blood, feces and urine sample collection; Other: LupusPRO questionnaire; Drug: Mycophenolate Mofetil (MMF) Treatment; Drug: Prednisolone |
| SLE without LN control | No intervention | 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 control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining single cell RNA sequencing differences within the full macrophage spectrum between arm 1 vs arm 2
The macrophage spectrum will be compared between baseline kidney biopsy and kidney biopsy at 3 months treatment. Differences in celltype proportions, gene expression and spatial organization will be assessed using spatial single cell RNA sequencing techniques.
Measured: From enrollment to the repeat kidney biopsy at 3 months after starting treatment
Secondary outcomes (6)
Analyze rapid clinical remission of intensified treatment by proteinuria levels for relation to tissue changes
Clinical remission achievement will be related to transcriptomic tissue signature
Measured: From enrollment to the end of follow-up at 24 months
Assess differences in macrophage subtypes within kidney tissue
Numerically distinguish residential macrophages and monocyte derived macrophages in kidney tissue with spatial scRNAseq, comparing arm 1 vs arm 2.
Measured: From enrollment to the repeat kidney biopsy at 3 months after starting treatment
Assess histological response of both treatment arms
Assessment of histological response of intensified treatment (arm 1) compared to dual therapy (arm 2)
Measured: From enrollment to the repeat kidney biopsy at 3 months after starting treatment
To assess phenotype of circulating monocytes in LN patients compared to SLE patients without clinical kidney involvement and healthy participants
Phenotype of circulating monocytes of LN patients will be associated with kidney tissue signature and compared to circulating monocyte phenotype of SLE patients without clinical kidney involvement and healthy participants.
Measured: From enrollment to the end of follow-up at 24 months
To identify potential non-invasive urinary biomarkers
To identify potential non invasive urinary biomarkers of disease activity in the scRNA-seq data, to be tested in sequentially stored urine and/or serum from patients
Measured: From enrollment to the end of follow-up at 24 months
Confirm scRNA-seq identified macrophage markers immunohistochemically, identify spatial distribution (glomerular vs interstitial) and assess their predictive and prognostic use.
Measured: From enrollment to the end of follow-up at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start23 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc L. Hilhorst, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760480
- Sponsor's protocol ID
- 2025-522187-32-01
- Other IDs
- 2025-522187-32-01, 2025
- Acronym
- MAPLE
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07760480
- Acronym / sponsor ID
- MAPLE / 2025-522187-32-01
- Keywords
- Lupus Nephritis, LN, SLE, Systemic lupus erythematosus, volcosporin, mmf, cellcept, prednisolone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Triple Therapy (MMF + Prednisolone + Voclosporin) | Active comparator | Procedure: Kidney Biopsy, Drug: Voclosporin (LUPKYNIS), Diagnostic Test: Blood, feces and urine sample collection, Other: LupusPRO questionnaire, Drug: Mycophenolate Mofetil (MMF) Treatment, Drug: PrednisoloneParticipants 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. |
| Dual Therapy (MMF + Prednisolone) | Active comparator | Procedure: Kidney Biopsy, Diagnostic Test: Blood, feces and urine sample collection, Other: LupusPRO questionnaire, Drug: Mycophenolate Mofetil (MMF) Treatment, Drug: PrednisoloneParticipants 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). |
| SLE without LN control | No intervention | –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 control | No intervention | –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. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kidney BiopsyAt 3 months after the start of treatment, participants will undergo a repeat renal biopsy for assessment of early histological response and for single-cell RNA sequencing. | Procedure or surgery | Dual Therapy (MMF + Prednisolone), Triple Therapy (MMF + Prednisolone + Voclosporin) |
| Voclosporin (LUPKYNIS)Arm 1 will receive triple therapy (addition of voclosporin) | Drug | Triple Therapy (MMF + Prednisolone + Voclosporin) |
| Blood, feces and urine sample collectionBlood, feces and urine samples will be collected at multiple timepoints during study follow-up period. | Diagnostic test | Dual Therapy (MMF + Prednisolone), Triple Therapy (MMF + Prednisolone + Voclosporin) |
| LupusPRO questionnaireThe lupusPRO v1.7 questionnaire (20) is a 43-question patient reported outcome survey tool to follow the impact of lupus or its treatment on the patient's quality of life. The questionnaire takes 7-8 minutes to complete and is validated and available in multiple languages. Participants will be asked to either fill in the questionnaire at home (and bring it on their next outpatient clinic visit) or while visiting the hospital during follow-up time. The questionnaires are filled in on paper. | Other | Dual Therapy (MMF + Prednisolone), Triple Therapy (MMF + Prednisolone + Voclosporin) |
| Mycophenolate Mofetil (MMF) TreatmentMMF 1000 mg twice daily (or 500 mg four times daily) | Drug | Dual Therapy (MMF + Prednisolone), Triple Therapy (MMF + Prednisolone + Voclosporin) |
| PrednisoloneFollowing intravenous methylprednisolone induction (500mg, 3 days), oral prednisolone 1 mg/kg/day tapered to ≤5 mg/day within 3 months. | Drug | Dual Therapy (MMF + Prednisolone), Triple Therapy (MMF + Prednisolone + Voclosporin) |
Primary outcome
Determining single cell RNA sequencing differences within the full macrophage spectrum between arm 1 vs arm 2
Time frame: From enrollment to the repeat kidney biopsy at 3 months after starting treatment
The macrophage spectrum will be compared between baseline kidney biopsy and kidney biopsy at 3 months treatment. Differences in celltype proportions, gene expression and spatial organization will be assessed using spatial single cell RNA sequencing techniques.
6 secondary outcomes
Analyze rapid clinical remission of intensified treatment by proteinuria levels for relation to tissue changes
Time frame: From enrollment to the end of follow-up at 24 months
Assess differences in macrophage subtypes within kidney tissue
Time frame: From enrollment to the repeat kidney biopsy at 3 months after starting treatment
Assess histological response of both treatment arms
Time frame: From enrollment to the repeat kidney biopsy at 3 months after starting treatment
To assess phenotype of circulating monocytes in LN patients compared to SLE patients without clinical kidney involvement and healthy participants
Time frame: From enrollment to the end of follow-up at 24 months
To identify potential non-invasive urinary biomarkers
Time frame: From enrollment to the end of follow-up at 24 months
Confirm scRNA-seq identified macrophage markers immunohistochemically, identify spatial distribution (glomerular vs interstitial) and assess their predictive and prognostic use.
Time frame: From enrollment to the end of follow-up at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kidney Biopsy, Voclosporin (LUPKYNIS) and Blood, feces and urine sample collection in people with Lupus Nephritis and Systemic Lupus Erythematosus (SLE), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining single cell RNA sequencing differences within the full macrophage spectrum between arm 1 vs arm 2 (time frame: From enrollment to the repeat kidney biopsy at 3 months after starting treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.