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Trial record 1 of 1 for:    NCT04080076
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Comparative and Efficacy Study of ACTHar Gel Alone or in Combination With Tacrolimus in Fibrillary Glomerulopathy (FACT)

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ClinicalTrials.gov Identifier: NCT04080076
Recruitment Status : Withdrawn (Study was updated and issued a new NCT number.)
First Posted : September 6, 2019
Last Update Posted : September 22, 2022
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
NephroNet, Inc.

Brief Summary:
Treatment with combination ACTHar gel and Tacrolimus therapy or ACTHar gel therapy alone in lowering urinary protein to creatinine (UP/Cr) ratios

Condition or disease Intervention/treatment Phase
Renal Disease Drug: Acthar 80 UNT/ML Injectable Solution Drug: Oral Tab Tacrolimus Phase 4

Detailed Description:

This is a multicenter, Phase 4, prospective, open labeled study to compare the safety, tolerability, and efficacy of a 12month course of ACTHar Gel and Tacrolimus therapy or ACTHar gel therapy alone in lowering urinary protein to creatinine (UP/Cr) ratios.

The addition of tacrolimus patients exhiba partial to ACTH resulted in a further reduction in Fibrillary.

Spe #1-will randomize with biopsy proven DNA-JB9 positive Fibrillary glomerulopathy to receive course of ACTHar gel alone at 80 units per week or in combination with oral Tacrolimus at 1 mg BID

Hypothesis Treatment with ACTHar Gel with oral Tacrolimus will result in a higher eGFR after 24 months of follow up than patients randomized to ACTHar gel therapy alone.

Hy3: Combination therapy of ACTHar Gel and Tacrolimus in patients with DNA-JB9 positive Fibrillary will lead to significant markers of podocyte injury compared ACTHar Gel alone.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

ACTHar gel alone- patients will receive 80units SQ 2X/week for 52 weeks

ACTH gel 80 units 2X per week plus oral Tacrolimus (1.0 mg BID) titrating to a trough level of 4-6 ng/ml for 52 weeks

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Comparative and Efficacy Study of ACTHar Gel Alone or in Combination With Tacrolimus in Fibrillary Glomerulopathy
Actual Study Start Date : January 12, 2019
Estimated Primary Completion Date : September 6, 2024
Estimated Study Completion Date : September 6, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ACTHar gel combined with Tacrolimus
ACTHar Gel units 2 times per week plus oral Tacrolimus (1.0 mg BID) titrating to a trough level of 4-6 ng/ml for 52 weeks
Drug: Acthar 80 UNT/ML Injectable Solution
ACTHar 80 Units SQ 1042 x Week

Drug: Oral Tab Tacrolimus
Oral Tab Tacrolimus (1.0 mg PO BID) in combination with ACTHar 80 Units SQ 2 X week

Active Comparator: ACTHar gel
ACTHar Gel units 2 times per week for 52 weeks
Drug: Acthar 80 UNT/ML Injectable Solution
ACTHar 80 Units SQ 1042 x Week

Drug: Oral Tab Tacrolimus
Oral Tab Tacrolimus (1.0 mg PO BID) in combination with ACTHar 80 Units SQ 2 X week




Primary Outcome Measures :
  1. change in UP/Cr ratio in patients with biopsy proven Fibrillary after treated with ACTHar gel alone OR in combination with oral Tacrolimus [ Time Frame: 12 months ]
    The change in UP/Cr ratio in patients with biopsy proven Fibrillary after 12 months of treatment with ACTHar gel (80 units SQ 2X/week) alone OR in combination with oral Tacrolimus (1.0 mg PO BID). The change in UP/Cr for each group will also be compared to baseline UP/Cr ratios prior to randomization


Secondary Outcome Measures :
  1. relative change in UP/Cr [ Time Frame: 24 months ]
    The relative change in UP/Cr at 24 months (12 months after stopping both ACTH and Tacrolimus) in the ACTHar gel group and the ACTHar gel + Tacrolimus group.

  2. T that achieves complete, partial or clinical responses [ Time Frame: 12 months ]
    The percentage of patients in the ACTHar gel alone ACTHar gel + Tacrolimus group that achieves complete, partial or clinical responses after 12 months of therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Histologic Inclusion Criteria:

All patients with a diagnosis of The Fibrillary GN wbe classified according to the Nasr nomenclature:

  1. Renal biopsy demonstrating JB9 Positive staining within 3 years of study randomization
  2. Mesangial expansion with/without glomerular sclerosis diffuse sclerosis

4) Crescents or capillary proliferation Note: Patients with > 50% interstitial fibrosis will not be eligible for study

Inclusion Criteria:

  1. Female ag
  2. Biopsy proven Fibrillary GN within 3 years of study randomization
  3. Stable Maximum RAAS inhibition X 40 weeks prior to randomization Note: Maximum inhibition will be the discretion of the site PI
  4. eGFR > 25 mls/min
  5. UP/Cr ratio > 2000 mg/gm 5 Note: IF UP/Cr less than 2000 mg/gm, a formal urine collection for total protein can be performed. The total 24-hour will need to >/= 2000mg.
  6. Blood pressure targeted to < 140 at the time of randomization
  7. Patients with MGUS without history of myeloma WILL be eligible.
  8. Patients with monoclonal staining for fibrillary fibers will be excluded
  9. Patients with Type II non-insulin dependent diabetes WILL be eligible provided the renal biopsy does not show nodular Kimmelstiel Wilson lesions

Exclusion

  1. Patients with MGUS and history of myeloma WILL be eligible
  2. Patients with active viral production of either B or C as evidence by historical PCR test positive for active viral shedding
  3. HIV seropositivity
  4. Renal biopsy data with > 5Interstitialxxxx Fibrosis
  5. Patient with active or a known history
  6. Patients with insulin Dependent diabetes mellitus will be excluded Note: Patients diabetes and are well controlled without the need for insulin WILL be eligible for the study.
  7. Patients with Type non-insulin diabetes WILL be eligible provided the renal biopsy does not s nodular Kimmelstiel Wilson lesions.
  8. Patients receiving steroids, MMF, cyc, Azathioprine or other immunosuppressive agent with of study random Note: Wash medications will be allowed at the screening visit
  9. Patients having received Rituximab or cell modifying biologic bbtherapy within 60 months of randomiza

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): NCT04080076


Locations
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United States, Georgia
Georgia Nephrology Research Institute
Lawrenceville, Georgia, United States, 30046
Sponsors and Collaborators
NephroNet, Inc.
Mallinckrodt
Investigators
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Principal Investigator: James A. Tumlin, MD NephroNet, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NephroNet, Inc.
ClinicalTrials.gov Identifier: NCT04080076    
Other Study ID Numbers: NN-
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: September 22, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action