Fibrillary GlomerulonephritisPhase 4FACTNCT05546047
A Study of Acthar Gel Alone or With Tacrolimus to Reduce Proteinuria in Fibrillary Glomerulopathy Patients
A Phase 4 study testing Acthar Gel 80 UNT/ML Injectable Solution in people with Fibrillary Glomerulonephritis, run by NephroNet, Inc. at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrillary Glomerulonephritis
- What is being tested?
- Acthar Gel 80 UNT/ML Injectable Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Mar 2019to 27 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado Anschutz Medical Department of Medicine Division of Renal Diseases and Hypertension
Aurora, Colorado, 80045
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
Georgia Nephrology DBA Georgia Nephrology Research Institute
Lawrenceville, Georgia, 30046
Columbia University Research Dept of Nephrology
New York, New York, 10032
Stanford University
Stanford, California, 94305
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Fibrillary Glomerulonephritis
- Being tested
- Acthar Gel 80 UNT/ML Injectable Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acthar Gel 80 UNT/ML Injectable SolutionDrug
Also called Tacrolimus 1.0 mg
Follow up and observation for 12 months off Acthar gel or Acthar gel and Tacrolimus
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Acthar gel | Active comparator | Group 1 - (17 patients) Acthar gel 80 units 2 times a week alone for 12 months of therapy. Receives: 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 Receives: Drug: Acthar Gel 80 UNT/ML Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 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
Measured: 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.
Measured: 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.
- Urinary VEGF 121, 165 189, and206
- Urinary MCP-1
- Urinary Synaptopodin
- Urinary TGF-beta
- Urinary Podocalyxin
- Urinary Nephrin
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start14 Mar 2019
- Primary completion27 Oct 2023 (estimated)
- Study completion27 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrillary GlomerulonephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 12-month treatment with combination Acthar gel and Tacrolimus therapy will be superior to Acthar gel therapy alone in lowering urinary protein to creatinine ratios in patients with Fibrillary glomerulonephritis
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NephroNet, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor
- Investigators
- Jeremy Whitson, BS, Study director, NephroNet, Inc.James Tumlin, MD, Principal investigator, NephroNet, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546047
- Sponsor's protocol ID
- NN-002
- Acronym
- FACT
- Status last verified
- Oct 2022
- First submitted
- 23 Aug 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05546047
- Acronym / sponsor ID
- FACT / NN-002
- Conditions
- Fibrillary Glomerulonephritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- NephroNet, Inc.University, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 27 Oct 2023 (estimated)
- Study completion
- 27 Oct 2024 (estimated)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A 12-month treatment with combination Acthar gel and Tacrolimus therapy will be superior to Acthar gel therapy alone in lowering urinary protein to creatinine ratios in patients with Fibrillary glomerulonephritis
| Arm | Type | Receives |
|---|---|---|
| Treatment with Acthar gel | Active comparator | Drug: Acthar Gel 80 UNT/ML Injectable SolutionGroup 1 - (17 patients) Acthar gel 80 units 2 times a week alone for 12 months of therapy. |
| Treatment with combination Acthar gel and Tacrolimus therapy | Active comparator | Drug: Acthar Gel 80 UNT/ML Injectable SolutionGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acthar Gel 80 UNT/ML Injectable SolutionAlso: Tacrolimus 1.0 mgFollow up and observation for 12 months off Acthar gel or Acthar gel and Tacrolimus | Drug | Treatment with Acthar gel, Treatment with combination Acthar gel and Tacrolimus therapy |
Primary outcome
The change in UP/CR ratio with treatment of Acthar gel 80 units subcutaneous 2 times a week alone
Time frame: 12 months
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
The change in UP/CR ratio with treatment of Acthar gel 80 units subcutaneous 2 times a week in combination with oral Tacrolimus
Time frame: 12 months
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.
4 secondary outcomes
The relative change in protein/creatinine ratio at 24 months
Time frame: 24 months
Percentage of patients complete or partial response
Time frame: 12 months
The change in Estimated Glomerular Filtration Rate
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
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Whitson, BS study director
NephroNet, Inc.
James Tumlin, MD principal investigator
NephroNet, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acthar Gel 80 UNT/ML Injectable Solution in people with Fibrillary Glomerulonephritis, run by NephroNet, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in UP/CR ratio with treatment of Acthar gel 80 units subcutaneous 2 times a week alone (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.