Phase 4
N=5
Adrenocorticotropic Hormone in Membranous Nephropathy
Membranous Nephropathy
Bottom Line
View on ClinicalTrials.gov: NCT03025828 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Change in Proteinuria — 4.56; 1.36 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ACTHar (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Proteinuria |
4.56; 1.36 | — |
| SECONDARY Number of Participants With Complete or Partial Remission |
0; 4 | — |
| SECONDARY Change in Serum Albumin |
3.0; 3.65 | — |
| SECONDARY Estimated Glomerular Filtration Rate (GFR) |
90.5; 80.5 | — |
| SECONDARY Number of Anti-PLA2R Memory B Cells |
— | — |
| SECONDARY Anti-PLA2R Antibodies Levels |
— | — |
| SECONDARY Change in CD4+CD25+CD127low T Regulatory Cells/CD4+ T Cell Ratio |
0.04; 0.12 | — |
Summary
The purpose of this study is to evaluate the effect of adrenocorticotropic hormone (ACTH, Acthar) on the loss of proteins in the urine (proteinuria) in patients with membranous nephropathy. Acthar is a hormone that stimulates steroid production from small glands above the kidneys. It has direct protective effects on the kidney and is currently approved by the FDA to treat kidney disorders associated with proteins in the urine, but the mechanisms of action are not entirely understood and will be studied in the present trial.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 70 years
- Free of immunosuppression for at least 3 months
- Capability of understanding the purpose of the study
- Written informed consent
Exclusion Criteria
- Epidermal growth factor receptor (eGFR) < 30ml/min/1.73m2
- Kidney Transplant
- Secondary MN (defined on the basis of clinical criteria)
- Type 1 or Type 2 diabetes mellitus (prior diagnosis of gestational diabetes mellitus is not an exclusion)
- History of previous use of Acthar for treatment of nephrotic syndrome
- Prior sensitivity to Acthar or other porcine protein products
- Contraindication to Acthar per Prescribing Information
- Planned treatment with live or live attenuated vaccines once enrolled in the study
- More than three previous treatment regiments
- Participation to other clinical trials over the previous 12 months
- History of cancer, except carcinoma in situ and treated basal and squamous cell carcinomas
- Pregnancy
- Lactation
- Current substance abuse
- Any clinically relevant condition that might affect study participation and/or study results
Data sourced from ClinicalTrials.gov (NCT03025828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.