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Synergy Trial: Belimumab and Voclosporin for Lupus Nephritis

This study, called the Synergy Trial, is looking at whether combining two approved medications, Belimumab and Voclosporin, can better treat lupus nephritis (lupus-related kidney disease) when added to standard therapy with Mycophenolate Mofetil (MMF) and Prednisone. The goal is to see if this combination helps more patients achieve complete kidney response and if it allows for stopping MMF sooner. You might be able to join if you are between 18 and 80 years old and have been diagnosed with lupus. The study will measure how well the treatment works after 12 months. The current recruitment status is unclear.

Study design
This is an open-label, randomized study involving about 30 participants. Participants will be randomly assigned to one of two groups, both receiving Voclosporin in addition to Belimumab, MMF, and Prednisone.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome will be measured at 12 months.

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NCT07225387

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial

Recruiting
PHASE4Ages 18–80InterventionalTreatment
NephroNet, Inc.
~30 participants
Updated 2025-11-06 on ClinicalTrials.gov
What's tested:Voclosporin

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcome Measure: Day 360 (12 Month) Outcome
Measured over 12 months

Conditions

Lupus Nephritis

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Where it's being run

7 sites across 5 states
Georgia3
Arizona1
Ohio1
Oklahoma1
Texas1

Study leadership

  • James Tumlin, MD · PRINCIPAL_INVESTIGATOR · NephroNet, Inc.

Who to contact

Jeremy Whitson
[email protected]
423-943-4265
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Combined hormonal (estrogen+progestin) contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation.
Progestogen- or progestin-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation.
Intrauterine device.
Intrauterine hormone-releasing system.
Bilateral tubal ligation/occlusion/division.
Vasectomized partner (considered a highly effective birth control method provided that partner is the sole sexual partner of the study subject and that the vasectomized partner has received medical assessment of the surgical success).
Sexual abstinence: defined as refraining from intercourse which may result in pregnancy during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject.

What this trial measures

  • Primary Outcome Measure: Day 360 (12 Month) Outcome12 months

    Proportion of Patients achieving and maintaining a Complete Clinical Renal Remission (CCRR) at 12 months. CCRR is defined as: UPCR≤ 0.5, eGFR≥60 and not \>20% below baseline, no rescue meds, sustained on repeat assessment 30 days later.