A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous Nephropathy

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cerium Pharmaceuticals, Inc.
Study ID
NCT05696613
Phase
PHASE3
Status
Unknown

Conditions

  • Primary Membranous Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SNP-ACTH (1-39) Gel — DRUG
    Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.
  • Rituximab — DRUG
    Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.

Study Details

The goal of the Phase 3a part of this clinical trial is to determine the optimal dose that will be used in the Phase 3b part of this clinical trial. The goal of the Phase 3b part is to assess the efficacy of SNP-ACTH (1-39) Gel relative to rituximab in patients with primary membranous nephropathy (PMN) at month 24.

Key Dates

Start date
Mar 13, 2023
Status verified
Apr 2024
Primary completion
Mar 1, 2025
Completion
Mar 1, 2026

Study Design

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

Arms

  • Experimental: Phase 3a Cohort 1
    3 mg SNP-ACTH Gel sc injection 3 times per week
  • Experimental: Phase 3a Cohort 2
    5 mg SNP-ACTH Gel sc injection 3 times per week
  • Experimental: Phase 3b Cohort 1
    Dose level to be confirmed once Phase 3a part is completed
  • Active Comparator: Phase 3b Cohort 2
    Rituximab arm: Patients randomized to the rituximab arm will receive 1 g IV infusion on T0 (after baseline measures are collected) and day 15. A second course of rituximab 1g IV infusion will be administered 6 months after the first rituximab infusion and an additional 1 g IV infusion 14 days following the first 6-month infusion.

Primary Outcome Measure

Change in urinary protein (Phase 3a) [ Time Frame: Change from baseline, months 1, 2, 3, 4, 5, 6, 9, and 12 ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Academic Medical Research InstituteLos AngelesCalifornia90022-
North America Research InstituteSan DimasCalifornia91773-
Valiance Clinical ResearchTarzanaCalifornia91356-
RecioMed Clinical Research Network, Inc.Boynton BeachFlorida33472-
South Florida Nephrology ResearchCoral SpringsFlorida33071-
Therafirst Medical CenterFort LauderdaleFlorida33308-
Reliant Medical Research, LLCMiamiFlorida33165-
Vista Health Research, LLCMiamiFlorida33176-
Genesis Clinical ResearchTampaFlorida33603-
Fides Clinical ResearchAtlantaGeorgia30342-
Costal Medical ResearchBrunswickGeorgia31520-
Insight Hospital and Medical Center ChicagoChicagoIllinois60615-
University of IowaIowa CityIowa52242-
Center for Advanced Kidney Research, PLCSaint Clair ShoresMichigan48080-
NYU Langone HealthNew YorkNew York10016-
Prolato Clinical Research CenterHoustonTexas77054-
P&I Clinical Research LLCLufkinTexas75904-
University of VirginiaCharlottesvilleVirginia22908-
Nephrology Associates of Northern VirginiaFairfaxVirginia22033-

Find similar trials in Los Angeles, CA

By research site
Academic Medical Research Institute· Los Angeles, CANorth America Research Institute· San Dimas, CAValiance Clinical Research· Tarzana, CARecioMed Clinical Research Network, Inc.· Boynton Beach, FLSouth Florida Nephrology Research· Coral Springs, FLTherafirst Medical Center· Fort Lauderdale, FL

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