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

Primary Purpose

Primary Membranous Nephropathy

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SNP-ACTH (1-39) Gel
Rituximab
Sponsored by
Cerium Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Membranous Nephropathy focused on measuring Kidney disease, Rituximab, Nephritis, Melanocortin, Hormones, Glucocorticoids, Glomerular Disease, ACTH, PMN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Biopsy-proven membranous glomerulonephritis or a diagnosis of MN in patients with Nephrotic Syndrome and a positive anti PLA2R antibody test. Patients classified to be at a High Risk for progressive loss of kidney function, as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2021-Glomerular Diseases Guideline. eGFR by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m^2 Patients who have had CR or PR in response to immunosuppressive therapy, but then relapsed can participate in the study if it has been more than 3 months since their last dose of high dose glucocorticoids, calcineurin inhibitors or mycophenolate mofetil Patients who have had CR or PR in response to IS therapy, but then relapsed can participate in the study if it has been more than 6 months since their last dose of chlorambucil or cyclophosphamide Patients who have had CR or PR in response to immunosuppressive therapy, but then relapsed can participate in the study if it has been more than 12 months since their last dose of rituximab. Life expectancy > 24 months. Other inclusion criteria may apply. Exclusion Criteria: Secondary membranous nephropathy as defined by history, physical exam, kidney biopsy results 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 not properly dosed. Surgery within 1 month of study entry History of sensitivity to proteins of porcine origin. Other exclusion criteria may apply.

Sites / Locations

  • Cerium Clinical SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Phase 3a Cohort 1

Phase 3a Cohort 2

Phase 3b Cohort 1

Phase 3b Cohort 2

Arm Description

3 mg SNP-ACTH Gel sc injection 3 times per week

5 mg SNP-ACTH Gel sc injection 3 times per week

Dose level to be confirmed once Phase 3a part is completed

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.

Outcomes

Primary Outcome Measures

Change in urinary protein (Phase 3a)
Change in Anti-phospholipase A2 receptor (PLA2R) auto-antibody levels (Phase 3a)
Complete response of PMN (Phase 3b)
Reduction of proteinuria to ≤0.3 g/24 hours as measured by urine protein/creatinine ratio obtained from a 24-hour urine collection with stable renal function defined as a <15% decline in eGFR at the time of endpoint assessment

Secondary Outcome Measures

Relapse rate at month 12 and month 24.
Anti-PLA2R (or Anti-THSD7A) auto-antibody levels.
Estimated glomerular filtration rate (eGFR) with proteinuria levels.
Adverse events
Incidence of ADAs
Number of patients who achieved a complete remission (CR) or partial remission (PR) at month 12.
Number of patients who achieved a Immunological Response (IR) at month 12.
Assessment of time to achieving CR, PR, IR.
Assessment of time to relapse for patients who achieved CR, PR, IR.
Duration of time between initial achievement of CR to latest date of observed remission.

Full Information

First Posted
December 29, 2022
Last Updated
June 2, 2023
Sponsor
Cerium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05696613
Brief Title
A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous Nephropathy
Official Title
A Phase 3 Superiority Study Comparing the Safety and Efficacy of SNP-ACTH (1-39) Gel Compared to Rituximab and FDA Approved Biosimilars in Adults With Primary Membranous Nephropathy (PMN) in a Two-Phase Adaptive Trial Design
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerium Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Membranous Nephropathy
Keywords
Kidney disease, Rituximab, Nephritis, Melanocortin, Hormones, Glucocorticoids, Glomerular Disease, ACTH, PMN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 3a Cohort 1
Arm Type
Experimental
Arm Description
3 mg SNP-ACTH Gel sc injection 3 times per week
Arm Title
Phase 3a Cohort 2
Arm Type
Experimental
Arm Description
5 mg SNP-ACTH Gel sc injection 3 times per week
Arm Title
Phase 3b Cohort 1
Arm Type
Experimental
Arm Description
Dose level to be confirmed once Phase 3a part is completed
Arm Title
Phase 3b Cohort 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SNP-ACTH (1-39) Gel
Intervention Description
Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan or other biosimilars
Intervention Description
Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.
Primary Outcome Measure Information:
Title
Change in urinary protein (Phase 3a)
Time Frame
Change from baseline, months 1, 2, 3, 4, 5, 6, 9, and 12
Title
Change in Anti-phospholipase A2 receptor (PLA2R) auto-antibody levels (Phase 3a)
Time Frame
Change from baseline, months 1, 2, 3, 4, 6, and 12
Title
Complete response of PMN (Phase 3b)
Description
Reduction of proteinuria to ≤0.3 g/24 hours as measured by urine protein/creatinine ratio obtained from a 24-hour urine collection with stable renal function defined as a <15% decline in eGFR at the time of endpoint assessment
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Relapse rate at month 12 and month 24.
Time Frame
12 and 24 months
Title
Anti-PLA2R (or Anti-THSD7A) auto-antibody levels.
Time Frame
12 and 24 months
Title
Estimated glomerular filtration rate (eGFR) with proteinuria levels.
Time Frame
12 and 24 months
Title
Adverse events
Time Frame
24 months
Title
Incidence of ADAs
Time Frame
24 months
Title
Number of patients who achieved a complete remission (CR) or partial remission (PR) at month 12.
Time Frame
12 months
Title
Number of patients who achieved a Immunological Response (IR) at month 12.
Time Frame
12 months
Title
Assessment of time to achieving CR, PR, IR.
Time Frame
24 months
Title
Assessment of time to relapse for patients who achieved CR, PR, IR.
Time Frame
12 and 24 months
Title
Duration of time between initial achievement of CR to latest date of observed remission.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy-proven membranous glomerulonephritis or a diagnosis of MN in patients with Nephrotic Syndrome and a positive anti PLA2R antibody test. Patients classified to be at a High Risk for progressive loss of kidney function, as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2021-Glomerular Diseases Guideline. eGFR by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m^2 Patients who have had CR or PR in response to immunosuppressive therapy, but then relapsed can participate in the study if it has been more than 3 months since their last dose of high dose glucocorticoids, calcineurin inhibitors or mycophenolate mofetil Patients who have had CR or PR in response to IS therapy, but then relapsed can participate in the study if it has been more than 6 months since their last dose of chlorambucil or cyclophosphamide Patients who have had CR or PR in response to immunosuppressive therapy, but then relapsed can participate in the study if it has been more than 12 months since their last dose of rituximab. Life expectancy > 24 months. Other inclusion criteria may apply. Exclusion Criteria: Secondary membranous nephropathy as defined by history, physical exam, kidney biopsy results 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 not properly dosed. Surgery within 1 month of study entry History of sensitivity to proteins of porcine origin. Other exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Klett, MPH
Phone
703-395-0629
Email
Nancy.Klett@ceriumpharma.com
Facility Information:
Facility Name
Cerium Clinical Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Klett

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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