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Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease

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ClinicalTrials.gov Identifier: NCT04009668
Recruitment Status : Recruiting
First Posted : July 4, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
New York University
Information provided by (Responsible Party):
Debbie Gipson, MD, University of Michigan

Brief Summary:
The researchers are testing adalimumab, a treatment which blocks tumor necrosis factor (TNF), to see if it changes levels of urine biomarker levels (TIMP1 and MCP1). The outcomes may help develop individualized treatment options for future patients with TNF driven Focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD).

Condition or disease Intervention/treatment Phase
FSGS MCD Focal Segmental Glomerulosclerosis Minimal Change Disease Drug: adalimumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Precision Medicine Proof of Concept for Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Experimental: adalimumab
Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously
Drug: adalimumab
Adalimumab will be dosed based on weight
Other Name: Humira




Primary Outcome Measures :
  1. Change in urine MCP1/Cr levels [ Time Frame: Baseline, Week 10 ]
    Change measured by for enzyme-linked immunosorbent assay (ELISA) testing

  2. Change in urine TIMP1/Cr levels [ Time Frame: Baseline, Week 10 ]
    Change measured by for enzyme-linked immunosorbent assay (ELISA) testing


Secondary Outcome Measures :
  1. Incidence adverse events (AEs) [ Time Frame: Through study week 14 ]
    Adverse events (AEs) include abnormal clinical laboratory tests and severe AEs.

  2. Percent change of estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline, Week 10 ]
    Measured by a blood sample. Summarized descriptively, including baseline, follow-up and changes from baseline.

  3. Percent change in Urine Protein Creatinine Ratio (UPC) [ Time Frame: Baseline, Week 10 ]
    Measured by a blood sample. Summarized descriptively, including baseline, follow-up and changes from baseline.

  4. Proportion of participants achieving a nadir Urine Protein Creatinine Ratio (UPC) less than 1.5 g/g and at least a 40% reduction from baseline [ Time Frame: Week 10 ]
    Urine specimen



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Ages Eligible for Study:   6 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Kidney biopsy confirmed Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD) within one year of enrollment
  • For Minimal Change Disease patients only, history of resistance to corticosteroid therapy
  • Qualifying archived biopsy tissue is available for testing of gene expression profiling
  • Increased urinary excretion of biomarkers of Tumor Necrosis Factor (TNF) activation (MCP1/Cr and/ or TIMP1/Cr) at study screening
  • eGFR>45 ml/min/1.73 m2 at screening
  • Urine protein:creatinine ratio ≥1.5 g/g at screening
  • Weight >15 kg
  • Stable therapy with angiotensin converting enzyme inhibitors, angiotensin receptor blockers, and oral immunosuppression agents for at least 30 days prior to enrollment
  • Birth control use in females of child bearing potential
  • Informed consent and assent if applicable

Exclusion Criteria:

  • Kidney or other solid organ or bone marrow transplant recipient
  • Allergy or intolerance to investigational agent
  • Secondary Focal Segmental Glomerulosclerosis (FSGS)
  • Severe obesity
  • Live virus vaccine in the past 3 months
  • Malignancy, current or in the past 5 years
  • Active local or systemic bacterial, fungal or viral infection
  • Active or latent Hepatitis B, Hepatitis C, HIV, or tuberculosis
  • History of demyelinating disease, e.g. Multiple Sclerosis or Guillain-Barre
  • History of heart failure
  • Active liver disease
  • Systemic lupus erythematosus or ANA > 1:80
  • History of inflammatory bowel disease, e.g. ulcerative colitis or Crohns disease
  • Cyclophosphamide in past 90 days, Rituximab in the past 180 days
  • Pregnancy or nursing
  • Blood white blood cell count <4,500/mm3; Hg <9 g/dL; Platelet count <150,000/mm3 at enrollment. - Use of an erythropoiesis stimulating agent will not be an exclusion criterion.
  • Concurrent use of interleukin-1 antagonist (Anakinra), other TNF blocking agent, methotrexate or abatacept
  • Diabetes Mellitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04009668


Contacts
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Contact: Emily Herreshoff 734-232-4830 umkidneystudies@umich.edu

Locations
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United States, Michigan
The University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Emily Herreshoff    734-232-4830    umkidneystudies@umich.edu   
Principal Investigator: Debbie Gipson, MS, MD         
United States, New York
New York University Not yet recruiting
New York, New York, United States, 10003
Principal Investigator: Howard Trachtman         
United States, Ohio
Cleveland Clinic Foundation Not yet recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: John Sedor, MD         
Sponsors and Collaborators
University of Michigan
New York University
Investigators
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Study Director: Debbie Gipson, MS, MD University of Michigan

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Responsible Party: Debbie Gipson, MD, Professor of Pediatrics and Communicable Diseases, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT04009668     History of Changes
Other Study ID Numbers: HUM00147018
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

This trial will follow the publication and data sharing policies of the NEPTUNE study, www.NEPTUNE-study.org

Request for ancillary studies should be submitted through the project contact and will be reviewed by the project steering committee.

After the study is completed, data will be submitted to the Nephrotic Syndrome Study Network (NEPTUNE), an NIH funded consortium. Proposals to access the data will then be submitted via the NEPTUNE Ancillary Studies program (NEPTUNE-study.org). Following closure of NEPTUNE, the trial data will convey with the NEPTUNE date to the NIH/NIDDK repository and can be accessed through this mechanism following approval.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: At the latest, data will be shared with the NEPTUNE Data Analysis and Coordinating Center at the time of publication of final results or 24 months after transfer of samples or raw data sets.
Access Criteria:

While this study is open data requests from this study will need to seek approval from the trial steering committee.

Once the data is transferred to the NEPTUNE study, all study data will become part of the aggregate NEPTUNE data and available to NEPTUNE participant sites and other requesting third parties upon request. Subsequent access to these data will be governed by the NIH Office of Rare Diseases (ORD) data sharing policies.

URL: http://neptune-study.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Debbie Gipson, MD, University of Michigan:
Kidney Disease
Minimal Change Disease
Nephrotic Syndrome
Focal Segmental Glomerulosclerosis
FSGS
Additional relevant MeSH terms:
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Glomerulosclerosis, Focal Segmental
Nephrosis, Lipoid
Necrosis
Pathologic Processes
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Nephrosis
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents