Membranous NephropathyPhase 4NCT03025828
Adrenocorticotropic Hormone in Membranous Nephropathy
A Phase 4 study testing ACTHar in people with Membranous Nephropathy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Membranous Nephropathy
- What is being tested?
- ACTHar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2018to 16 Dec 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years
- Free of immunosuppression for at least 3 months
- Capability of understanding the purpose of the study
- Written informed consent
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Changes in Autoreactive Memory B Cells as Biomarker of Response to Adrenocorticotropic Hormone in Patients With Membranous Nephropathy
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.
Read the detailed description
Patients with membranous nephropathy and nephrotic syndrome will be treated with ACTH for 6 months. Proteinuria remission at 12 months will be the primary endpoint. Different biomarkers including anti-PLA2R autoantibodies, circulating regulatory T cells, and autoreactive memory B cells will be serially measured to identify predictors of response to therapy.
- Conditions
- Membranous Nephropathy
- Being tested
- ACTHar
- Keywords
- Membranous nephropathy, adrenocorticotropic hormone, ACTH, proteinuria, glomerulonephritis
- Medical subject headings
- Glomerulonephritis, Membranous, Proteinuria, Glomerulonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTHarDrug
Also called ACTH, Acthar Injectable Product, Repository corticotropin injection, RCI
for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Acthar | Experimental | Acthar will be administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly Receives: Drug: ACTHar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Proteinuria
Change in proteinuria at baseline versus after 12 months of treatment as measured by urine protein/creatinine ratio
Measured: baseline and 12 months
Secondary outcomes (6)
Number of Participants With Complete or Partial Remission
Complete (proteinuria reduction <500mg/24h) or partial (urinary protein excretion (P/C) <3.0 g/g (with at least 50% reduction versus baseline) in at least two consecutive visits) remission.
Measured: 12 months
Change in Serum Albumin
Change in serum albumin from baseline
Measured: baseline 6 months, 12 months
Estimated Glomerular Filtration Rate (GFR)
GFR measures kidney function.
Measured: baseline and 12 months
Number of Anti-PLA2R Memory B Cells
Number of anti-PLA2R memory B cells
Measured: 12 months
Anti-PLA2R Antibodies Levels
blood levels
Number of anti-PLA2R memory B cells
Measured: 12 months
Change in CD4+CD25+CD127low T Regulatory Cells/CD4+ T Cell Ratio
blood levels - one single cell subset identified by different markers
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start19 Mar 2018
- Primary completion16 Dec 2020
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Cravedi, Icahn School of Medicine at Mount Sinai
- Investigators
- Paolo Cravedi, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025828
- Sponsor's protocol ID
- GCO 16-2402
- Status last verified
- Jul 2022
- First submitted
- 17 Jan 2017
- Last updated
- 15 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Autoreactive Memory B Cells as Biomarker of Response to Adrenocorticotropic Hormone in Patients With Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT03025828
- Acronym / sponsor ID
- GCO 16-2402
- Conditions
- Membranous Nephropathy
- Keywords
- Membranous nephropathy, adrenocorticotropic hormone, ACTH, proteinuria, glomerulonephritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Posted 15 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with membranous nephropathy and nephrotic syndrome will be treated with ACTH for 6 months. Proteinuria remission at 12 months will be the primary endpoint. Different biomarkers including anti-PLA2R autoantibodies, circulating regulatory T cells, and autoreactive memory B cells will be serially measured to identify predictors of response to therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acthar | Experimental | Drug: ACTHarActhar will be administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 70 years
- Free of immunosuppression for at least 3 months
- Capability of understanding the purpose of the study
- Written informed consent
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| ACTHarAlso: ACTH, Acthar Injectable Product, Repository corticotropin injection, RCIfor 6 months | Drug | Acthar |
Primary outcome
Change in Proteinuria
Time frame: baseline and 12 months
Change in proteinuria at baseline versus after 12 months of treatment as measured by urine protein/creatinine ratio
6 secondary outcomes
Number of Participants With Complete or Partial Remission
Time frame: 12 months
Change in Serum Albumin
Time frame: baseline 6 months, 12 months
Estimated Glomerular Filtration Rate (GFR)
Time frame: baseline and 12 months
Number of Anti-PLA2R Memory B Cells
Time frame: 12 months
Anti-PLA2R Antibodies Levels
Time frame: 12 months
Change in CD4+CD25+CD127low T Regulatory Cells/CD4+ T Cell Ratio
Time frame: baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Paolo Cravedi, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ACTHar in people with Membranous Nephropathy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 4 inclusion and 15 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: finished, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Proteinuria (time frame: baseline and 12 months). 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 15 Aug 2022.