Comparative and Efficacy Study of ACTHar Gel Alone or in Combination With Tacrolimus in Fibrillary Glomerulopathy

NCT04080076 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: NN-
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Disease

Outcome Measures

Primary Outcomes (1)

• change in UP/Cr ratio in patients with biopsy proven Fibrillary after treated with ACTHar gel alone OR in combination with oral Tacrolimus

  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

  12 months

Secondary Outcomes (2)

• relative change in UP/Cr

  24 months

• T that achieves complete, partial or clinical responses

  12 months

Study Arms (2)

ACTHar gel combined with Tacrolimus

ACTIVE COMPARATOR

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; Drug: Oral Tab Tacrolimus

ACTHar gel

ACTIVE COMPARATOR

ACTHar Gel units 2 times per week for 52 weeks

Drug: Acthar 80 UNT/ML Injectable Solution; Drug: Oral Tab Tacrolimus

Interventions

Acthar 80 UNT/ML Injectable Solution DRUG

ACTHar 80 Units SQ 1042 x Week

ACTHar gel; ACTHar gel combined with Tacrolimus

Oral Tab Tacrolimus DRUG

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

ACTHar gel; ACTHar gel combined with Tacrolimus

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• All patients with a diagnosis of The Fibrillary GN wbe classified according to the Nasr nomenclature:
• Renal biopsy demonstrating JB9 Positive staining within 3 years of study randomization
• Mesangial expansion with/without glomerular sclerosis diffuse sclerosis
• \) Crescents or capillary proliferation Note: Patients with \> 50% interstitial fibrosis will not be eligible for study
• Female ag
• Biopsy proven Fibrillary GN within 3 years of study randomization
• Stable Maximum RAAS inhibition X 40 weeks prior to randomization Note: Maximum inhibition will be the discretion of the site PI
• eGFR \> 25 mls/min
• 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.
• Blood pressure targeted to \< 140 at the time of randomization
• Patients with MGUS without history of myeloma WILL be eligible.
• Patients with monoclonal staining for fibrillary fibers will be excluded
• Patients with Type II non-insulin dependent diabetes WILL be eligible provided the renal biopsy does not show nodular Kimmelstiel Wilson lesions

You may not qualify if:

• Patients with MGUS and history of myeloma WILL be eligible
• Patients with active viral production of either B or C as evidence by historical PCR test positive for active viral shedding
• HIV seropositivity
• Renal biopsy data with \> 5Interstitialxxxx Fibrosis
• Patient with active or a known history
• 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.
• Patients with Type non-insulin diabetes WILL be eligible provided the renal biopsy does not s nodular Kimmelstiel Wilson lesions.
• Patients receiving steroids, MMF, cyc, Azathioprine or other immunosuppressive agent with of study random Note: Wash medications will be allowed at the screening visit
• Patients having received Rituximab or cell modifying biologic bbtherapy within 60 months of randomiza

Sponsors & Collaborators

• NephroNet, Inc.: lead
• Mallinckrodt: collaborator

Study Sites (1)

Georgia Nephrology Research Institute

Lawrenceville, Georgia, 30046, United States

Location

Related Publications (1)

• Canetta P. Disentangling a Case of Glomerulonephritis with Fibrils. Clin J Am Soc Nephrol. 2022 Jul;17(7):1070-1072. doi: 10.2215/CJN.00630122. Epub 2022 Jun 2. No abstract available.

  PMID: 35654563 DERIVED

MeSH Terms

Conditions

Kidney Diseases

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• James A. Tumlin, MD

  NephroNet, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: September 6, 2019
• Study Start: January 12, 2019
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)