A Study of Acthar Gel Alone or With Tacrolimus to Reduce... | NCT05546047

Status Module

Name	Class
Mallinckrodt	INDUSTRY

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment with Acthar gel	Active Comparator	Group 1 - (17 patients) Acthar gel 80 units 2 times a week alone for 12 months of therapy.	Drug: Acthar Gel 80 UNT/ML Injectable Solution
Treatment with combination Acthar gel and Tacrolimus therapy	Active Comparator	Group 2 - (17 patients) Acthar get 80 units 2 times a week plus oral Tacrolimus 1.0 mg two times a day titrated to trough Tacrolimus levels between 4-6 ng/ml	Drug: Acthar Gel 80 UNT/ML Injectable Solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acthar Gel 80 UNT/ML Injectable Solution	Drug	Follow up and observation for 12 months off Acthar gel or Acthar gel and Tacrolimus	Treatment with Acthar gel Treatment with combination Acthar gel and Tacrolimus therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change in UP/CR ratio with treatment of Acthar gel 80 units subcutaneous 2 times a week alone	The change in protein/creatinine ratio in patients with biopsy proven Fibrillary after 12 months of treatment with treated with Acthar gel (80 units subcutaneous 2 times a week) alone	12 months
The change in UP/CR ratio with treatment of Acthar gel 80 units subcutaneous 2 times a week in combination with oral Tacrolimus	The change in protein/creatinine ratio in patients with biopsy proven Fibrillary after 12 months of treatment with treated with Acthar gel 80 units 2 times a week subcutaneous week in combination with oral Tacrolimus 1.0 mg orally two times a day.	12 months

Secondary Outcomes

Measure	Description	Time Frame
The relative change in protein/creatinine ratio at 24 months	The relative change in protein/creatinine at 24 months (12 months after stopping both Acthar and Tacrolimus) in the Acthar gel group and the Acthar gel plus Tacrolimus group.	24 months
Percentage of patients complete or partial response

Other Outcomes

Measure	Description	Time Frame
To determine if patients with concurrent Type II diabetes mellitus resulted in hyperglycemia, increased proteinuria, loss of renal function or led to immunosuppressive therapies	To determine whether Acthar gel therapy resulted in hyperglycemia in patients with concurrent Diabetes and whether that led to early termination from the study. We will also determine whether the presence of diabetes led to increased proteinuria over time, led to more rapid decline in renal function and altered the response to immunosuppressive therapy.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male/Female age > 18
Biopsy proven Fibrillary glomerulonephritis within 3 years of study randomization
Stable Maximum Renin-Angiotensin-Aldosterone System inhibition times 4 weeks prior to randomization Note: Maximum RAAS inhibition will be left to the discretion of the site Principal Investigator
Estimated Glomerular Filtration Rate > 25 mls/min calculate by the Chronic Kidney Disease-EPI formula
Protein/creatinine ratio > 2000 mg/gm 5) Note: If protein/creatinine less than 2000 mg/gm, a formal 24- hour urine collection for total protein can be performed. The total 24-hour protein will need to >/= 2000mg.
Blood pressure targeted to < 140/90 at the time of randomization
Patients with Monoclonal Gammopathy 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

Exclusion Criteria:

Patients with MGUS and history of myeloma will not be eligible
Patients with active viral production of either hepatitis B or C as evidence by historical polymerase chain reaction test positive for active viral shedding
HIV seropositivity
Renal biopsy data with > 50% Interstitial Fibrosis
Patient with active or a known history lymphoma
Patients with insulin dependent diabetes mellitus will be excluded Note: patients with Type II diabetes mellitus that are well controlled without the need for insulin will be eligible for the study.
Patients with Type II non-insulin dependent diabetes will be eligible provided the renal biopsy does not show nodular Kimmelstiel Wilson lesions.
Patients receiving steroids, mycophenolate mofetil, cyclophosphamide, Azathioprine or other immunosuppressive agent with 4 weeks of study randomization Note: Washout of these medications will be allowed at the screening visit
Patients having received Rituximab or B cell modifying biologic therapy within 6 months of randomization

Name	Affiliation	Role
Jeremy Whitson, BS	NephroNet, Inc.	Study Director
James Tumlin, MD	NephroNet, Inc.	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Stanford	California	94305	United States
University of Colorado Anschutz Medical Department of Medicine Division of Renal Diseases and Hypertension