NCT03025828

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 19, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2020

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 15, 2022

Completed
Last Updated

August 15, 2022

Status Verified

July 1, 2022

Enrollment Period

2.7 years

First QC Date

January 17, 2017

Results QC Date

July 20, 2022

Last Update Submit

July 20, 2022

Conditions

Membranous Nephropathy

Keywords

Membranous nephropathyadrenocorticotropic hormoneACTHproteinuriaglomerulonephritis

Outcome Measures

Primary Outcomes (1)

  • Change in Proteinuria

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

    baseline and 12 months

Secondary Outcomes (6)

  • Number of Participants With Complete or Partial Remission

    12 months

  • Change in Serum Albumin

    baseline 6 months, 12 months

  • Estimated Glomerular Filtration Rate (GFR)

    baseline and 12 months

  • Number of Anti-PLA2R Memory B Cells

    12 months

  • Anti-PLA2R Antibodies Levels

    12 months

  • +1 more secondary outcomes

Study Arms (1)

Acthar

EXPERIMENTAL

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

Drug: ACTHar

Interventions

ACTHarDRUG

for 6 months

Also known as: ACTH, Acthar Injectable Product, Repository corticotropin injection, RCI, Acthar® Gel
Acthar

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 70 years
  • Free of immunosuppression for at least 3 months
  • Capability of understanding the purpose of the study
  • Written informed consent

You may not qualify if:

  • Epidermal growth factor receptor (eGFR) \< 30ml/min/1.73m2
  • Kidney Transplant
  • Secondary MN (defined on the basis of clinical criteria)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Glomerulonephritis, MembranousProteinuriaGlomerulonephritis

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

NephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Results Point of Contact

Title
Dr. Kirk Campbell
Organization
Icahn School of Medicine at Mount Sinai
kirk.campbell@mssm.edu
212-241-6271

Study Officials

  • Paolo Cravedi, MD, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Nephrology

Study Record Dates

First Submitted

January 17, 2017

First Posted

January 20, 2017

Study Start

March 19, 2018

Primary Completion

December 16, 2020

Study Completion

December 16, 2020

Last Updated

August 15, 2022

Results First Posted

August 15, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)