Renal DiseasePhase 4FACTNCT04080076
Comparative and Efficacy Study of ACTHar Gel Alone or in Combination With Tacrolimus in Fibrillary Glomerulopathy
A Phase 4 study testing Acthar 80 UNT/ML Injectable Solution and Oral Tab Tacrolimus in people with Renal Disease, run by NephroNet, Inc. at 1 site in United States.
Trial summary
Treatment with combination ACTHar gel and Tacrolimus therapy or ACTHar gel therapy alone in lowering urinary protein to creatinine (UP/Cr) ratios Read more about this study
- Who is it for?
- Ages 65 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Renal Disease
- What is being tested?
- Acthar 80 UNT/ML Injectable Solution and Oral Tab Tacrolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2019to 6 Sep 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 65 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Nephrology Research Institute
Lawrenceville, Georgia, 30046
About this study
Official title: A Multicenter Comparative and Efficacy Study of ACTHar Gel Alone or in Combination With Tacrolimus in Fibrillary Glomerulopathy
Treatment with combination ACTHar gel and Tacrolimus therapy or ACTHar gel therapy alone in lowering urinary protein to creatinine (UP/Cr) ratios
Read the detailed description
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
- Renal Disease
- Being tested
- Acthar 80 UNT/ML Injectable Solution, Oral Tab Tacrolimus
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acthar 80 UNT/ML Injectable SolutionDrug
ACTHar 80 Units SQ 1042 x Week
Oral Tab TacrolimusDrug
Oral Tab Tacrolimus (1.0 mg PO BID) in combination with ACTHar 80 Units SQ 2 X week
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Acthar 80 UNT/ML Injectable Solution; Drug: Oral Tab Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
relative change in UP/Cr
The relative change in UP/Cr at 24 months (12 months after stopping both ACTH and Tacrolimus) in the ACTHar gel group and the ACTHar gel + Tacrolimus group.
Measured: 24 months
T that achieves complete, partial or clinical responses
The percentage of patients in the ACTHar gel alone ACTHar gel + Tacrolimus group that achieves complete, partial or clinical responses after 12 months of therapy
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 posted6 Sep 2019
- Study start12 Jan 2019
- Primary completion6 Sep 2024 (estimated)
- Study completion6 Sep 2024 (estimated)
Why it stopped: Study was updated and issued a new NCT number.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal DiseaseStudies 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
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NephroNet, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor
- Investigators
- James A. Tumlin, MD, Principal investigator, NephroNet, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080076
- Sponsor's protocol ID
- NN-
- Acronym
- FACT
- Status last verified
- Sep 2022
- First submitted
- 28 Jun 2019
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35654563
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Comparative and Efficacy Study of ACTHar Gel Alone or in Combination With Tacrolimus in Fibrillary Glomerulopathy
- ClinicalTrials.gov ID
- NCT04080076
- Acronym / sponsor ID
- FACT / NN-
- Conditions
- Renal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was updated and issued a new NCT number.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NephroNet, Inc.University, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- 6 Sep 2024 (estimated)
- Study completion
- 6 Sep 2024 (estimated)
- First posted
- 6 Sep 2019 (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.
Treatment with combination ACTHar gel and Tacrolimus therapy or ACTHar gel therapy alone in lowering urinary protein to creatinine (UP/Cr) ratios
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| ACTHar gel combined with Tacrolimus | Active comparator | Drug: Acthar 80 UNT/ML Injectable Solution, Drug: Oral Tab TacrolimusACTHar 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 |
| ACTHar gel | Active comparator | Drug: Acthar 80 UNT/ML Injectable Solution, Drug: Oral Tab TacrolimusACTHar Gel units 2 times per week for 52 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
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 80 UNT/ML Injectable SolutionACTHar 80 Units SQ 1042 x Week | Drug | ACTHar gel, ACTHar gel combined with Tacrolimus |
| Oral Tab TacrolimusOral Tab Tacrolimus (1.0 mg PO BID) in combination with ACTHar 80 Units SQ 2 X week | Drug | ACTHar gel, ACTHar gel combined with Tacrolimus |
Primary outcome
change in UP/Cr ratio in patients with biopsy proven Fibrillary after treated with ACTHar gel alone OR in combination with oral Tacrolimus
Time frame: 12 months
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
2 secondary outcomes
relative change in UP/Cr
Time frame: 24 months
T that achieves complete, partial or clinical responses
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Derived from this study: PubMed 35654563Canetta 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.
- 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.
James A. Tumlin, MD principal investigator
NephroNet, Inc.
1 site 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 80 UNT/ML Injectable Solution and Oral Tab Tacrolimus in people with Renal Disease, run by NephroNet, Inc. at 1 site 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: withdrawn, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
change in UP/Cr ratio in patients with biopsy proven Fibrillary after treated with ACTHar gel alone OR in combination with oral Tacrolimus (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04080076, which also lists 1 linked publication.
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 22 Sep 2022.