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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Adrenocorticotropic Hormone in Membranous Nephropathy

NCTNCT03025828 (opens ClinicalTrials.gov in a new tab)Other idGCO 16-2402
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
5 participants (actual)
Sponsor
Icahn School of Medicine at Mount Sinai · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
19 Mar 2018
Primary completion
16 Dec 2020
Completion
16 Dec 2020
First posted
20 Jan 2017 (estimated)
Last update posted
15 Aug 2022
Conditions
Membranous Nephropathy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018201920202021
  1. Ph 4

    Adrenocorticotropic Hormone in Membranous Nephropathy

    NCT03025828

    19 Mar 2018 to 16 Dec 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ACTHarDrug

Arms1

  • Experimental

    Acthar

    Acthar will be administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Proteinuria

    Time frame · baseline and 12 months

    Registry description

    Change in proteinuria at baseline versus after 12 months of treatment as measured by urine protein/creatinine ratio

Secondary outcomes(6)

  1. Number of Participants With Complete or Partial Remission

    Time frame · 12 months

    Registry description

    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.

  2. Change in Serum Albumin

    Time frame · baseline 6 months, 12 months

    Registry description

    Change in serum albumin from baseline

  3. Estimated Glomerular Filtration Rate (GFR)

    Time frame · baseline and 12 months

    Registry description

    GFR measures kidney function.

  4. Number of Anti-PLA2R Memory B Cells

    Time frame · 12 months

    Registry description

    Number of anti-PLA2R memory B cells

  5. Anti-PLA2R Antibodies Levels

    Time frame · 12 months

    Registry description

    blood levels Number of anti-PLA2R memory B cells

  6. Change in CD4+CD25+CD127low T Regulatory Cells/CD4+ T Cell Ratio

    Time frame · baseline and 12 months

    Registry description

    blood levels - one single cell subset identified by different markers

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· baseline and 12 months

Change in Proteinuria

GroupValue (ratio)
Acthar4.56
Secondary and other outcome results(6)
Secondary outcomeCount of participants· 12 months

Number of Participants With Complete or Partial Remission

GroupValue (Participants)
Acthar0
Secondary outcomeMedian· baseline 6 months, 12 months

Change in Serum Albumin

GroupValue (g/dl)
Acthar3.0
Secondary outcomeMedian· baseline and 12 months

Estimated Glomerular Filtration Rate (GFR)

GroupValue (mL/min)
Acthar90.5
Secondary outcome· 12 months

Number of Anti-PLA2R Memory B Cells

GroupValue
Actharnot posted
Secondary outcome· 12 months

Anti-PLA2R Antibodies Levels

GroupValue
Actharnot posted
Secondary outcomeMedian· baseline and 12 months

Change in CD4+CD25+CD127low T Regulatory Cells/CD4+ T Cell Ratio

GroupValue (ratio)
Acthar0.04

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ActharActhar administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly for 6 months of treatment with a cumulative dose exposure of 3,920 units.0 / 40 / 40 / 4

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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