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

Last updated: April 24, 2024
Sponsor: Cerium Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Glomerulonephritis

Nephrotic Syndrome

Idiopathic Membranous Nephropathy

Treatment

Rituximab

SNP-ACTH (1-39) Gel

Clinical Study ID

NCT05696613
ACTH-PMN-301
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Biopsy-proven membranous glomerulonephritis or a diagnosis of MN in patients withNephrotic Syndrome and a positive anti PLA2R antibody test.
  • Patients classified to be at a High Risk for progressive loss of kidney function, asdefined by Kidney Disease Improving Global Outcomes (KDIGO) 2021-Glomerular DiseasesGuideline.
  • eGFR by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40mL/min/1.73 m^2
  • Patients who have had CR or PR in response to immunosuppressive therapy, but thenrelapsed can participate in the study if it has been more than 3 months since theirlast dose of high dose glucocorticoids, calcineurin inhibitors or mycophenolatemofetil
  • Patients who have had CR or PR in response to IS therapy, but then relapsed canparticipate in the study if it has been more than 6 months since their last dose ofchlorambucil or cyclophosphamide
  • Patients who have had CR or PR in response to immunosuppressive therapy, but thenrelapsed can participate in the study if it has been more than 12 months since theirlast dose of rituximab.
  • Life expectancy > 24 months.
  • Other inclusion criteria may apply.

Exclusion

Exclusion Criteria:

  • Secondary membranous nephropathy as defined by history, physical exam, kidney biopsyresults or serologies.
  • Patients who have had a ≥ 50% reduction in serum titers of PLA2R auto-antibody within 1 year before screening.
  • Type 1 or 2 diabetes mellitus
  • Patients who must be initiated on drugs likely to affect renal function if notproperly dosed.
  • Surgery within 1 month of study entry
  • History of sensitivity to proteins of porcine origin.
  • Other exclusion criteria may apply.

Study Design

Total Participants: 148
Treatment Group(s): 2
Primary Treatment: Rituximab
Phase: 3
Study Start date:
March 13, 2023
Estimated Completion Date:
March 01, 2026

Study Description

This head-to-head, open-label, 2-phase superiority trial compares SNP-ACTH (1-39) Gel to rituximab in the treatment of PMN that commences with an adaptive trial design for dose finding. The trial will be divided into 2 parts: Phase 3a and Phase 3b.

Dose finding Phase 3a part of the study will enroll a total of 16 patients randomized to 2 different dose levels of SNP-ACTH (1-39) Gel treatment for 12 months. Dose levels will be:

  • 8 patients at 3mg SNP-ACTH Gel subcutaneous (sc) injection 3 times per week;

  • 8 patients at 5mg SNP-ACTH Gel sc injection 3 times per week

Data from the Phase 3a part of the study will be assessed at regular intervals (at months 2, 3, 4, 5, 6, 9, 12) and will inform the dose selection for the Phase 3b. The optimal dose will be determined based on a risk/benefit assessment from data obtained from the Phase 3a part of the study, with the earliest assessment being conducted after all patients have completed at least 2 months of therapy.

The Phase 3b part of the study will enroll 132 patients randomized 1:1 to either 12 months of 1g Rituximab therapy (2 treatment cycles at month 1 and month 6) or 12 months of SNP-ACTH (1-39) Gel treatment at the dose level determined in the Phase 3a.

Connect with a study center

  • Regional Kidney Wellness Centre

    Brampton, Ontario L6T 0H9
    Canada

    Active - Recruiting

  • Vedanta Hospitals

    Guntur, Andhra Pradesh 522001
    India

    Active - Recruiting

  • Vijaya Super Speciality Hospital

    Nellore, Andhra Pradesh 524001
    India

    Active - Recruiting

  • AIIMS

    Raipur, Chhattisgarh 492099
    India

    Active - Recruiting

  • Sir Ganga Ram Hospital

    New Delhi, Delhi 10060
    India

    Active - Recruiting

  • Muljibhai Patel Urological Hospital

    Nadiād, Gujarat
    India

    Active - Recruiting

  • KLE Hospital

    Belgaum, Karnataka 590010
    India

    Active - Recruiting

  • Saraswati Kidney Care Center

    Nagpur, Maharashtra 440015
    India

    Active - Recruiting

  • PGIMER

    Chandigarh, Punjab 160012
    India

    Active - Recruiting

  • Apex Hospitals

    Jaipur, Rajasthan 302017
    India

    Active - Recruiting

  • SMS Medical College and Hospital

    Jaipur, Rajasthan 302004
    India

    Active - Recruiting

  • Galaxy Hospital

    Varanasi, Uttar Pradesh 221010
    India

    Active - Recruiting

  • Academic Medical Research Institute

    Los Angeles, California 90022
    United States

    Active - Recruiting

  • North America Research Institute

    San Dimas, California 91773
    United States

    Active - Recruiting

  • Valiance Clinical Research

    Tarzana, California 91356
    United States

    Active - Recruiting

  • Cerium Clinical Site

    Boca Raton, Florida 33431
    United States

    Site Not Available

  • RecioMed Clinical Research Network, Inc.

    Boynton Beach, Florida 33472
    United States

    Active - Recruiting

  • South Florida Nephrology Research

    Coral Springs, Florida 33071
    United States

    Active - Recruiting

  • Therafirst Medical Center

    Fort Lauderdale, Florida 33308
    United States

    Active - Recruiting

  • Reliant Medical Research, LLC

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Vista Health Research, LLC

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Genesis Clinical Research

    Tampa, Florida 33603
    United States

    Active - Recruiting

  • Fides Clinical Research

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Costal Medical Research

    Brunswick, Georgia 31520
    United States

    Active - Recruiting

  • Insight Hospital and Medical Center Chicago

    Chicago, Illinois 60615
    United States

    Active - Recruiting

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Center for Advanced Kidney Research, PLC

    Saint Clair Shores, Michigan 48080
    United States

    Active - Recruiting

  • Cerium Clinical Site

    Saint Clair Shores, Michigan 48080
    United States

    Active - Recruiting

  • Cerium Clinical Site

    New York, New York 10016
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Active - Recruiting

  • P&I Clinical Research LLC

    Lufkin, Texas 75904
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Nephrology Associates of Northern Virginia

    Fairfax, Virginia 22033
    United States

    Active - Recruiting

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