A Phase 4 interventional study of Kidney Biopsy and Voclosporin (LUPKYNIS) in Lupus Nephritis and Systemic Lupus Erythematosus (SLE), sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 1 site in Netherlands. Open to participants aged 16 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Phase 4, Interventional, and Treatment
Among 23 studies testing Mycophenolic Acid in Lupus Nephritis — 7 open to participants now, 7 under way, none of them phase 3. Mycophenolic Acid · Lupus Nephritis.
Among the 23 studies testing Mycophenolic Acid in Lupus Nephritis, this one is the 12th largest by planned enrollment, is one of 2 that started in 2026, is one of 6 in phase 4, and was the 23rd registered.
340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.
Browse Lupus Nephritis studies →7 of the 23 studies testing Mycophenolic Acid in Lupus Nephritis are open now, in 4 countries. Recruiting first, the newest first:
Nanjing University School of Medicine · Sites in China
Children's Hospital Medical Center, Cincinnati · Sites in United States
Chinese SLE Treatment And Research Group · Sites in China
Second Xiangya Hospital of Central South University · Sites in China
Institutul Clinic Fundeni · Sites in Romania
By country, each count listing its studies:
Mycophenolic Acid: first FDA approval 1995 (CELLCEPT), first EMA approval 1996. What it is approved for, and how studies give it, is on its page →
Of the 88 Lupus Nephritis studies recruiting now, 30 (34%) set no upper age limit and 51 (58%) stop at 75 or younger; 29 take children under 18; 7 take healthy volunteers.
This study: 16 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 55 is above the median of 48 across 242 interventional studies indexed under Lupus Nephritis.
Median enrollment 55 across the 23 interventional studies. Of the 14 that completed or were terminated, 4 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 23 have an industry lead sponsor. The 10 most frequent:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 183 are open to participants now.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) has 1 study filed under Lupus Nephritis — fewer than ten, so there is no comparison to draw.
2 of the studies testing Mycophenolic Acid in Lupus Nephritis that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05538208Children's Hospital Medical Center, CincinnatiThe Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study | 2027-01 |
| NCT07340463Nanjing University School of MedicineThe Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment | 2027-06 |
Among the 23 studies testing Mycophenolic Acid in Lupus Nephritis, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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:
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:
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.
Lupus nephritis patients
Inclusion Criteria:
Exclusion Criteria:
tacrolimus, belimumab, anifrolumab - Treatment with any of the following agents within 6 months before screening: rituximab, daratumumab, eculizumab
Pregnancy
SLE patients without LN (disease control group) Inclusion criteria
Exclusion criteria
Healthy subjects (control group) Inclusion criteria
Exclusion criteria
- Signs of active infection
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Kidney Biopsy · Drug: Voclosporin (LUPKYNIS) · Diagnostic Test: Blood, feces and urine sample collection · Other: LupusPRO questionnaire · Drug: Mycophenolate Mofetil (MMF) Treatment · Drug: Prednisolone
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).
Procedure: Kidney Biopsy · Diagnostic Test: Blood, feces and urine sample collection · Other: LupusPRO questionnaire · Drug: Mycophenolate Mofetil (MMF) Treatment · Drug: Prednisolone
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 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.
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.
Arm 1 will receive triple therapy (addition of voclosporin)
Blood, feces and urine samples will be collected at multiple timepoints during study follow-up period.
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.
MMF 1000 mg twice daily (or 500 mg four times daily)
Following intravenous methylprednisolone induction (500mg, 3 days), oral prednisolone 1 mg/kg/day tapered to ≤5 mg/day within 3 months.
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.
Time frame: From enrollment to the repeat kidney biopsy at 3 months after starting treatment
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
Time frame: 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.
Time frame: 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)
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
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.
Time frame: 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
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started Apr 2026 (actual). Primary completion is estimated for Apr 2028, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drugs tested here: Voclosporin · Mycophenolic Acid · Prednisolone
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) →