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

Part of paid clinical trials in Glendale, Arizona.

Sponsor
NephroNet, Inc.
Study ID
NCT07225387
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Voclosporin — DRUG
    The trial is an open label, parallel, randomized study with patients randomized 1:1 the EARLY MMF TERMINATION (90 days) ARM or the EXTENDED MMF (360 days) ARM looking at the addition of Voclosporin in patients with Lupus Nephritis taking Belimumab, MMF, and Prednisone.

Study Details

This is a Phase IV, open-label, randomized trial to determine whether the combination of Belimumab (BEL) and Voclosporin (VCS), plus background therapy with Mycophenolate Mofetil (MMF), improves the proportion of patients with proliferative lupus nephritis achieving complete renal response (CRR) compared to proportion of patients achieving CRR from recent clinical trials. This protocol will additionally determine whether combination therapy using Belimumab (BEL) and Voclosporin (VCS) facilitates rapid discontinuation of MMF.

Key Dates

Start date
Oct 1, 2024
Status verified
Nov 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: EARLY MMF TERMINATION (90 days) ARM
    EARLY MMF TERMINATION (90 days) ARM in which subjects are randomized 1:1
  • Active Comparator: EXTENDED MMF (360 days) ARM
    EXTENDED MMF TERMINATION (360 days) ARM in which subjects are randomized 1:1

Primary Outcome Measure

Primary Outcome Measure: Day 360 (12 Month) Outcome [ Time Frame: 12 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
AARA Clinical ResearchGlendaleArizona85306
Cody Price
[email protected]
602-386-4970
Eric Peters, MD (PRINCIPAL_INVESTIGATOR)
Piedmont Physicians RheumatologyAtlantaGeorgia30318
Kimberly Pruitt
[email protected]
404-367-3350
Wambui Machua, MD (PRINCIPAL_INVESTIGATOR)
Georgia Nephrology Research InstituteLawrencevilleGeorgia30046
Jeremy Whitson, CCRA, CCRP
[email protected]
423-943-4264
Terry Smith
[email protected]
423-967-0917
James A Tumlin, MD (PRINCIPAL_INVESTIGATOR)
Parris & AssociatesLawrencevilleGeorgia30046
Mannai Coutermarsh
[email protected]
678-471-6289
Glen Parris, MD (PRINCIPAL_INVESTIGATOR)
Nephrology Clinical Trials Unit The Ohio State University Wexner Medical CenterColumbusOhio43201
Laci Roberts
[email protected]
614-685-5323
Isabelle Ayoub, MD (PRINCIPAL_INVESTIGATOR)
Oklahoma Medical Research FoundationOklahoma CityOklahoma73104
Kallena Haynes
[email protected]
405-271-3046
Christina Arriens, MD (PRINCIPAL_INVESTIGATOR)
AARA Clinical ResearchFort WorthTexas76109
Lainne Carey
[email protected]
214-276-6560
Shariq Chudhri, DO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Glendale, AZ

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
AARA Clinical Research· Glendale, AZPiedmont Physicians Rheumatology· Atlanta, GAGeorgia Nephrology Research Institute· Lawrenceville, GAParris & Associates· Lawrenceville, GANephrology Clinical Trials Unit The Ohio State University Wexner Medical Center· Columbus, OHOklahoma Medical Research Foundation· Oklahoma City, OK

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