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Monoclonal Antibodies
SNP-ACTH Gel for Kidney Disease
Phase 3
Recruiting
Research Sponsored by Cerium Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Biopsy-proven membranous glomerulonephritis or a diagnosis of MN in patients with Nephrotic Syndrome and a positive anti PLA2R antibody test
eGFR by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m^2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline, months 1, 2, 3, 4, 5, 6, 9, and 12
Awards & highlights
Study Summary
This trial will study a gel to see if it's effective at treating PMN, comparing it to a drug already used to treat it.
Who is the study for?
This trial is for patients with primary membranous nephropathy, a kidney disease. They should have a life expectancy over 24 months, confirmed diagnosis via biopsy or positive anti PLA2R antibody test if they have Nephrotic Syndrome, and be at high risk of worsening kidney function. Participants must not have had certain treatments recently and cannot have diabetes or sensitivity to porcine proteins.Check my eligibility
What is being tested?
The study is testing SNP-ACTH (1-39) Gel against Rituximab in two phases: Phase 3a to find the best dose and Phase 3b to compare their effectiveness after 24 months in treating primary membranous nephropathy.See study design
What are the potential side effects?
Possible side effects may include reactions related to protein sensitivities, as those with known sensitivity to porcine proteins are excluded from the trial. Specific side effects will depend on the intervention received.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with membranous nephropathy and tested positive for anti-PLA2R antibodies.
Select...
My kidney function, measured by eGFR, is adequate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline, months 1, 2, 3, 4, 5, 6, 9, and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline, months 1, 2, 3, 4, 5, 6, 9, and 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Anti-phospholipase A2 receptor (PLA2R) auto-antibody levels (Phase 3a)
Change in urinary protein (Phase 3a)
Complete response of PMN (Phase 3b)
Secondary outcome measures
Adverse events
Anti-PLA2R (or Anti-THSD7A) auto-antibody levels.
Assessment of time to achieving CR, PR, IR.
+7 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Phase 3b Cohort 1Experimental Treatment1 Intervention
Dose level to be confirmed once Phase 3a part is completed
Group II: Phase 3a Cohort 2Experimental Treatment1 Intervention
5 mg SNP-ACTH Gel sc injection 3 times per week
Group III: Phase 3a Cohort 1Experimental Treatment1 Intervention
3 mg SNP-ACTH Gel sc injection 3 times per week
Group IV: Phase 3b Cohort 2Active Control1 Intervention
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.
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Who is running the clinical trial?
Cerium Pharmaceuticals, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are at high risk for kidney function loss, according to the KDIGO 2021-Glomerular Diseases Guideline.I had a good response to immune therapy but my condition worsened after stopping it for over a year.I have been diagnosed with secondary membranous nephropathy.I have been diagnosed with membranous nephropathy and tested positive for anti-PLA2R antibodies.Your blood test showed a big decrease in a specific antibody within the past year.I had a good response to immune therapy but my condition worsened after stopping. It's been over 3 months since my last strong immune therapy dose.I had a good response to immune therapy but my condition worsened after 6 months since my last chlorambucil or cyclophosphamide dose.I have type 1 or type 2 diabetes.I need medication that could affect my kidney function if not dosed correctly.You have had a bad reaction to proteins from pigs in the past.I have not had surgery in the last month.You are expected to live for more than 2 years.My kidney function, measured by eGFR, is adequate.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 3a Cohort 2
- Group 2: Phase 3a Cohort 1
- Group 3: Phase 3b Cohort 1
- Group 4: Phase 3b Cohort 2
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still capacity for patients to join this clinical experiment?
"As per the clinicaltrials.gov website, this experiment is actively recruiting participants. Initially posted on March 13th 2023 and modified last June 2nd 2023, it now awaits enrolment of new patients."
Answered by AI
How many individuals are being recruited as participants for this experiment?
"Affirmative. Clinicaltrials.gov data indicates that this medical test is actively enlisting participants since its first posting on March 13th 2023 and up until June 2nd of the same year. The trial requires 148 volunteers from one single site to be enrolled."
Answered by AI
Has Cohort 1 in Phase 3a been granted permission by the FDA?
"Thanks to its Phase 3 status, demonstrating efficacy and extensive safety data collection, our team has assigned a score of 3 for the security of Stage 3a Cohort 1."
Answered by AI
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