A Phase 3 interventional study of SNP-ACTH (1-39) Gel and Rituximab in Primary Membranous Nephropathy, sponsored by Cerium Pharmaceuticals, Inc.. Recruiting at 31 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Cerium Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
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.
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:
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.
969 studies on the registry are indexed under Kidney Diseases; 183 are open to participants now.
This study's planned enrollment of 148 is above the median of 64 across 647 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →This is the only study on the registry with Cerium Pharmaceuticals, Inc. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3 mg SNP-ACTH Gel sc injection 3 times per week
Drug: SNP-ACTH (1-39) Gel
5 mg SNP-ACTH Gel sc injection 3 times per week
Drug: SNP-ACTH (1-39) Gel
Dose level to be confirmed once Phase 3a part is completed
Drug: SNP-ACTH (1-39) Gel
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.
Drug: Rituximab
Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.
Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.
Also known as: Rituxan or other biosimilars
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)
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2023 (actual). Primary completion is estimated for Apr 2027, 48 months after the start.
Of 45 phase 3 interventional studies under Kidney Diseases, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 69. This study's planned 48 months is below that.
How these figures are worked out, and which studies are left out of them.
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