Primary Membranous NephropathyPhase 3NCT05696613
A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous Nephropathy
A Phase 3 study testing SNP-ACTH (1-39) Gel and Rituximab in people with Primary Membranous Nephropathy, run by Cerium Pharmaceuticals, Inc. at 31 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- SNP-ACTH (1-39) Gel and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 31 sitesin 3 countries
- Study dates
- 13 Mar 2023to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 3 countries
United States19 sites, 19 recruiting
- Recruiting
Fides Clinical Research
Atlanta, Georgia, 30342
- Recruiting
RecioMed Clinical Research Network, Inc.
Boynton Beach, Florida, 33472
- Recruiting
Costal Medical Research
Brunswick, Georgia, 31520
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
- Recruiting
Insight Hospital and Medical Center Chicago
Chicago, Illinois, 60615
- Recruiting
South Florida Nephrology Research
Coral Springs, Florida, 33071
- Recruiting
Nephrology Associates of Northern Virginia
Fairfax, Virginia, 22033
- Recruiting
Therafirst Medical Center
Fort Lauderdale, Florida, 33308
- Recruiting
Prolato Clinical Research Center
Houston, Texas, 77054
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
- Recruiting
Academic Medical Research Institute
Los Angeles, California, 90022
- Recruiting
P&I Clinical Research LLC
Lufkin, Texas, 75904
- Recruiting
Reliant Medical Research, LLC
Miami, Florida, 33165
- Recruiting
Vista Health Research, LLC
Miami, Florida, 33176
- Recruiting
NYU Langone Health
New York, New York, 10016
- Recruiting
Center for Advanced Kidney Research, PLC
Saint Clair Shores, Michigan, 48080
- Recruiting
North America Research Institute
San Dimas, California, 91773
- Recruiting
Genesis Clinical Research
Tampa, Florida, 33603
- Recruiting
Valiance Clinical Research
Tarzana, California, 91356
India11 sites, 11 recruiting
- Recruiting
KLE Hospital
Belagavi, Karnataka, 590010
- Recruiting
PGIMER
Chandigarh, Punjab, 160012
- Recruiting
Vedanta Hospitals
Guntur, Andhra Pradesh, 522001
- Recruiting
SMS Medical College and Hospital
Jaipur, Rajasthan, 302004
- Recruiting
Apex Hospitals
Jaipur, Rajasthan, 302017
- Recruiting
Muljibhai Patel Urological Hospital
Nadiād, Gujarat
- Recruiting
Saraswati Kidney Care Center
Nagpur, Maharashtra, 440015
- Recruiting
Vijaya Super Speciality Hospital
Nellore, Andhra Pradesh, 524001
- Recruiting
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 10060
- Recruiting
AIIMS
Raipur, Chhattisgarh, 492099
- Recruiting
Galaxy Hospital
Varanasi, Uttar Pradesh, 221010
Canada1 site, 1 recruiting
- Recruiting
Regional Kidney Wellness Centre
Brampton, Ontario, L6T 0H9
About this study
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
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.
Read the 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 up to 24 patients randomized to 2 different dose levels of SNP-ACTH (1-39) Gel treatment for 12 months. Dose levels will be:
- approximately 12 patients at 3mg SNP-ACTH Gel subcutaneous (sc) injection 3 times per week;
- approximately 12 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.
- Conditions
- Primary Membranous Nephropathy
- Being tested
- SNP-ACTH (1-39) Gel, Rituximab
- Keywords
- Kidney disease, Rituximab, Nephritis, Melanocortin, Hormones, Glucocorticoids, Glomerular Disease, ACTH, PMN
- Medical subject headings
- Kidney Diseases, Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNP-ACTH (1-39) GelDrug
Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.
RituximabDrug
Also called Rituxan or other biosimilars
Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.
| Study group | Role | What they receive |
|---|---|---|
| Phase 3a Cohort 1 | Experimental | 3 mg SNP-ACTH Gel sc injection 3 times per week Receives: Drug: SNP-ACTH (1-39) Gel |
| Phase 3a Cohort 2 | Experimental | 5 mg SNP-ACTH Gel sc injection 3 times per week Receives: Drug: SNP-ACTH (1-39) Gel |
| Phase 3b Cohort 1 | Experimental | Dose level to be confirmed once Phase 3a part is completed Receives: Drug: SNP-ACTH (1-39) Gel |
| Phase 3b Cohort 2 | Active comparator | 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. Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary protein (Phase 3a)
Measured: Change from baseline, months 1, 2, 3, 4, 5, 6, 9, and 12
Change in Anti-phospholipase A2 receptor (PLA2R) auto-antibody levels (Phase 3a)
Measured: Change from baseline, months 1, 2, 3, 4, 6, and 12
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
Measured: 24 months
Secondary outcomes (10)
Relapse rate at month 12 and month 24.
Measured: 12 and 24 months
Anti-PLA2R (or Anti-THSD7A) auto-antibody levels.
Measured: 12 and 24 months
Estimated glomerular filtration rate (eGFR) with proteinuria levels.
Measured: 12 and 24 months
Adverse events
Measured: 24 months
Incidence of ADAs
Measured: 24 months
Number of patients who achieved a complete remission (CR) or partial remission (PR) at month 12.
Measured: 12 months
Number of patients who achieved a Immunological Response (IR) at month 12.
Measured: 12 months
Assessment of time to achieving CR, PR, IR.
Measured: 24 months
Assessment of time to relapse for patients who achieved CR, PR, IR.
Measured: 12 and 24 months
Duration of time between initial achievement of CR to latest date of observed remission.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start13 Mar 2023
- Primary completion1 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cerium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696613
- Sponsor's protocol ID
- ACTH-PMN-301
- Status last verified
- Mar 2026
- First submitted
- 29 Dec 2022
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05696613
- Acronym / sponsor ID
- ACTH-PMN-301
- Conditions
- Primary Membranous Nephropathy
- Keywords
- Kidney disease, Rituximab, Nephritis, Melanocortin, Hormones, Glucocorticoids, Glomerular Disease, ACTH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Cerium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 up to 24 patients randomized to 2 different dose levels of SNP-ACTH (1-39) Gel treatment for 12 months. Dose levels will be:
- approximately 12 patients at 3mg SNP-ACTH Gel subcutaneous (sc) injection 3 times per week;
- approximately 12 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 3a Cohort 1 | Experimental | Drug: SNP-ACTH (1-39) Gel3 mg SNP-ACTH Gel sc injection 3 times per week |
| Phase 3a Cohort 2 | Experimental | Drug: SNP-ACTH (1-39) Gel5 mg SNP-ACTH Gel sc injection 3 times per week |
| Phase 3b Cohort 1 | Experimental | Drug: SNP-ACTH (1-39) GelDose level to be confirmed once Phase 3a part is completed |
| Phase 3b Cohort 2 | Active comparator | Drug: RituximabRituximab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNP-ACTH (1-39) GelSubjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product. | Drug | Phase 3a Cohort 1, Phase 3a Cohort 2, Phase 3b Cohort 1 |
| RituximabAlso: Rituxan or other biosimilarsSubjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product. | Drug | Phase 3b Cohort 2 |
Primary outcome
Change in urinary protein (Phase 3a)
Time frame: Change from baseline, months 1, 2, 3, 4, 5, 6, 9, and 12
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
Complete response of PMN (Phase 3b)
Time frame: 24 months
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
10 secondary outcomes
Relapse rate at month 12 and month 24.
Time frame: 12 and 24 months
Anti-PLA2R (or Anti-THSD7A) auto-antibody levels.
Time frame: 12 and 24 months
Estimated glomerular filtration rate (eGFR) with proteinuria levels.
Time frame: 12 and 24 months
Adverse events
Time frame: 24 months
Incidence of ADAs
Time frame: 24 months
Number of patients who achieved a complete remission (CR) or partial remission (PR) at month 12.
Time frame: 12 months
Number of patients who achieved a Immunological Response (IR) at month 12.
Time frame: 12 months
Assessment of time to achieving CR, PR, IR.
Time frame: 24 months
Assessment of time to relapse for patients who achieved CR, PR, IR.
Time frame: 12 and 24 months
Duration of time between initial achievement of CR to latest date of observed remission.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Primary Membranous Nephropathy
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2/3
Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
Primary Membranous Nephropathy
Active, not recruitingPhase 1/2
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
Lupus Nephritis, Immunoglobulin A Nephropathy
RecruitingPhase 2
A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease
Primary Membranous Nephropathy
RecruitingPhase 2
A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy
Primary Membranous Nephropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SNP-ACTH (1-39) Gel and Rituximab in people with Primary Membranous Nephropathy, run by Cerium Pharmaceuticals, Inc. at 31 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, India, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Klett, MPH (703-395-0629, Nancy.Klett@ceriumpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urinary protein (Phase 3a) (time frame: Change from baseline, months 1, 2, 3, 4, 5, 6, 9, and 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.