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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-12

Study Completion Date

2024-09-06

Brief Summary

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

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Detailed Description

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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.

Conditions

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Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Acthar 80 UNT/ML Injectable Solution

Intervention Type DRUG

ACTHar 80 Units SQ 1042 x Week

Oral Tab Tacrolimus

Intervention Type DRUG

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

ACTHar gel

ACTHar Gel units 2 times per week for 52 weeks

Group Type ACTIVE_COMPARATOR

Acthar 80 UNT/ML Injectable Solution

Intervention Type DRUG

ACTHar 80 Units SQ 1042 x Week

Oral Tab Tacrolimus

Intervention Type DRUG

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

Interventions

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Acthar 80 UNT/ML Injectable Solution

ACTHar 80 Units SQ 1042 x Week

Intervention Type DRUG

Oral Tab Tacrolimus

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

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes