Can a Three-Drug combo quiet lupus kidney flares?
NCT ID NCT07760480
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This trial tests whether adding voclosporin to standard lupus nephritis treatment (mycophenolate mofetil and prednisolone) reduces kidney inflammation faster and more completely than standard treatment alone. Adults with active lupus nephritis will be randomly assigned to either triple or dual therapy, and will undergo kidney biopsies before and after 3 months of treatment to see how immune cells in the kidney respond. The study also looks for blood or urine markers that could monitor disease without repeated biopsies, and follows participants for up to 2 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- voclosporin added to standard treatment with mycophenolate mofetil and prednisolone
- What this could lead to
- If adding voclosporin works, it could lead to faster and more complete remission of kidney inflammation in lupus nephritis, potentially preserving kidney function and reducing long-term damage.
- What could go wrong
- This is a relatively small, early-phase trial, so results may not apply broadly. Adding voclosporin may increase side effects without improving outcomes, and the study's focus on early tissue changes may not predict long-term benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 55 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Amsterdam University Medical Center
RECRUITINGAmsterdam, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody aims to wipe out Lupus-Causing immune cells
- 5,000-Patient registry aims to map the Long-Term course of lupus nephritis
- Can a blood test catch lupus flares earlier?
- Can a single CAR-T infusion reset the immune system and stop lupus kidney damage?
- Can a single cell therapy calm multiple autoimmune diseases?
- Blood markers may foretell kidney trouble in lupus