New gel could outperform standard therapy for kidney disease
NCT ID NCT05696613
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial is testing a new gel called SNP-ACTH (1-39) against the standard drug rituximab in 148 adults with primary membranous nephropathy, a rare kidney condition. The goal is to see if the gel can better reduce protein in the urine and protect kidney function over 24 months. Participants are at high risk of kidney decline and will be randomly assigned to one of the two treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SNP-ACTH (1-39) Gel
- What this could lead to
- If this works, it could offer a new treatment option for people with a rare kidney disease, potentially reducing protein leakage and preserving kidney function better than current therapies.
- What could go wrong
- This is still an early-stage Phase 3 trial with only 148 participants, so results may not apply to everyone. The gel may not prove superior to rituximab, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 148 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
31 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AIIMS
RECRUITINGRaipur, Chhattisgarh, 492099, India
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Academic Medical Research Institute
RECRUITINGLos Angeles, California, 90022, United States
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Apex Hospitals
RECRUITINGJaipur, Rajasthan, 302017, India
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Center for Advanced Kidney Research, PLC
RECRUITINGSaint Clair Shores, Michigan, 48080, United States
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Costal Medical Research
RECRUITINGBrunswick, Georgia, 31520, United States
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Fides Clinical Research
RECRUITINGAtlanta, Georgia, 30342, United States
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Galaxy Hospital
RECRUITINGVaranasi, Uttar Pradesh, 221010, India
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Genesis Clinical Research
RECRUITINGTampa, Florida, 33603, United States
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Insight Hospital and Medical Center Chicago
RECRUITINGChicago, Illinois, 60615, United States
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KLE Hospital
RECRUITINGBelagavi, Karnataka, 590010, India
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Muljibhai Patel Urological Hospital
RECRUITINGNadiād, Gujarat, India
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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Nephrology Associates of Northern Virginia
RECRUITINGFairfax, Virginia, 22033, United States
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North America Research Institute
RECRUITINGSan Dimas, California, 91773, United States
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P&I Clinical Research LLC
RECRUITINGLufkin, Texas, 75904, United States
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PGIMER
RECRUITINGChandigarh, Punjab, 160012, India
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Prolato Clinical Research Center
RECRUITINGHouston, Texas, 77054, United States
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RecioMed Clinical Research Network, Inc.
RECRUITINGBoynton Beach, Florida, 33472, United States
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Regional Kidney Wellness Centre
RECRUITINGBrampton, Ontario, L6T 0H9, Canada
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Reliant Medical Research, LLC
RECRUITINGMiami, Florida, 33165, United States
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SMS Medical College and Hospital
RECRUITINGJaipur, Rajasthan, 302004, India
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Saraswati Kidney Care Center
RECRUITINGNagpur, Maharashtra, 440015, India
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Sir Ganga Ram Hospital
RECRUITINGNew Delhi, National Capital Territory of Delhi, 10060, India
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South Florida Nephrology Research
RECRUITINGCoral Springs, Florida, 33071, United States
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Therafirst Medical Center
RECRUITINGFort Lauderdale, Florida, 33308, United States
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University of Iowa
RECRUITINGIowa City, Iowa, 52242, United States
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University of Virginia
RECRUITINGCharlottesville, Virginia, 22908, United States
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Valiance Clinical Research
RECRUITINGTarzana, California, 91356, United States
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Vedanta Hospitals
RECRUITINGGuntur, Andhra Pradesh, 522001, India
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Vijaya Super Speciality Hospital
RECRUITINGNellore, Andhra Pradesh, 524001, India
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Vista Health Research, LLC
RECRUITINGMiami, Florida, 33176, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A new tool to predict kidney failure risk in membranous nephropathy?
- Can engineered immune cells tackle a tough kidney disease?
- Can a smarter antibody outsmart a kidney disease that resists standard treatment?
- Can engineered immune cells tame autoimmune kidney disease?
- Can a pill calm the immune attack on kidneys?
- Can a gene-silencing drug calm overactive complement in kidney disease?