A Phase 4 interventional study of Acthar Gel 80 UNT/ML Injectable Solution in Fibrillary Glomerulonephritis, sponsored by NephroNet, Inc.. Status unknown at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-31.
Sponsored by NephroNet, Inc. · Phase 4, Interventional, and Treatment
A Multicenter, Comparative Safety and Efficacy Study of Acthar gel alone or in combination with oral Tacrolimus to reduce urinary proteinuria in patients with idiopathic DNAJB9 Positive Fibrillary glomerulopathy.
A Multicenter, Comparative Safety and Efficacy Study of Acthar gel alone or in combination with oral Tacrolimus to reduce urinary proteinuria in patients with idiopathic DNAJB9 Positive Fibrillary glomerulopathy. This study will be a multi-center, prospective, randomized, open-labeled intervention trial of 34 patients randomized to 52 weeks of ACTHar gel alone or Acthar gel plus oral Tacrolimus.
234 studies on the registry are indexed under Proteinuria; 43 are open to participants now.
This study's planned enrollment of 34 is below the median of 60 across 164 interventional studies indexed under Proteinuria.
Browse Proteinuria studies →NephroNet, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Follow up and observation for 12 months off Acthar gel or Acthar gel and Tacrolimus
Also known as: Tacrolimus 1.0 mg
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
Time frame: 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.
Time frame: 12 months
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.
Time frame: 24 months
Percentage of patients complete or partial response
The percentage of patients in the Acthar gel alone versus Acthar gel + Tacrolimus group that achieves complete, partial or clinical responses after 12 months of therapy
Time frame: 12 months
The change in Estimated Glomerular Filtration Rate
The change in Estimated Glomerular Filtration Rate between the Acthar gel and Acthar Gel plus Tacrolimus groups after 24 months of treatment with Acthar gel alone or in combination with oral Tacrolimus. In addition, we will also compare the relative change in eGFR between those patients receiving Acthar gel alone with those randomized to combination therapy.
Time frame: 24 months
To compare the change in urinary biomarkers of Urinary VEGF 121, 165 189, and206, Urinary MCP-1, Urinary Synaptopodin, Urinary TGF-beta, Urinary Podocalyxin, and Urinary Nephrin
To compare the change in urinary biomarkers at baseline and after 12 months of treatment with Acthar gel alone or in combination with Tacrolimus. The patients urinary biomarker levels after 12 months of therapy will be compared between the Acthar gel alone group and Acthar gel plus Tacrolimus group. 1. Urinary VEGF 121, 165 189, and206 2. Urinary MCP-1 3. Urinary Synaptopodin 4. Urinary TGF-beta 5. Urinary Podocalyxin 6. Urinary Nephrin
Time frame: 12 months
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.
Time frame: 24 months
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Plan to share: No
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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NephroNet, Inc.