Progressive IgA NephropathyPhase 3NCT02282930
Pilot Study of ACTH in the Treatment of Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
A Phase 3 study testing ACTH (Acthar) Gel in people with Progressive IgA Nephropathy and Proteinuria, run by Mayo Clinic at 4 sites in United States.
Trial summary
This study is designed to answer whether patients with progressive IgA nephropathy, who receive Acthar (ACTH) gel injection at a dose of 80 units subcutaneously twice weekly for 6 months is effective in inducing improvement in proteinuria and renal function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive IgA Nephropathy, Proteinuria
- What is being tested?
- ACTH (Acthar) Gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2015to 30 Jun 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Proteinuria > 1000 mg/24h despite documented ACEi/ARB therapy and adequate blood pressure control for > 3 months.
- Quantified 24h creatinine clearance > 30 ml/min/1.73m2.
- Blood pressure < 130/80 mmHg at > 75% of the readings.
- Henoch Schoenlein Purpura (HSP): Patients with biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein Purpura will be considered eligible for the study.
- Patient must be able to receive injections to be enrolled in the study.
- Patient must have a kidney biopsy slide on file - that can be sent to Mayo Clinic.
Who cannot join
- Clinical and histologic evidence of IgA predominant Lupus nephritis
- Patients with greater than 50% glomerular senescence or cortical scarring on renal biopsy.
- Serum Cr > 3.0 mg/dL or creatinine clearance glomerular filtration rate (GFR) < 30 ml/min at the time of screening
- Patients with history of Crohn's disease or Celiac Sprue
- Clinical evidence of cirrhosis, chronic active liver disease.
- Known infection with hepatitis B, hepatitis C, or HIV (Patients will be serologically screened prior to study entry (if the rest has been completed in the last two years, the patient will not have to undergo additional testing).
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- Active systemic infection with bacterial, viral, fungal, or mycobacterial or atypical mycobacterial infections (excluding fungal infections of nail beds).
- Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
- Positive pregnancy test or breast feeding at time of study entry (urine pregnancy test will be performed for all women of childbearing potential no later than 7 days prior to treatment) or patients unwilling to comply with contraceptive measures as outlined above.
- Patients receiving therapy with oral prednisone or glucocorticoid equivalent in the past 3 months.
- Patients who had received immunosuppressive therapy including cyclophosphamide, mycophenolate mofetil (MMF), cyclosporine, tacrolimus or azathioprine in the last 6 months.
- Current or recent (within 30 days) exposure to any investigational drug.
- Patients having received a live vaccine within 28 days of study enrollment.
- Hemoglobin: < 8.5 gm/dL
- Platelets: < 100,000/mm
- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 2.5 x Upper Limit of Normal
- Patients with anaphylaxis and/or known allergic reactions to ACTH
- Previous Treatment with ACTH
- History of drug, alcohol, or chemical abuse within 6 months prior to screening
- Concomitant or previous malignancies, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- History of psychiatric disorder that would interfere with normal participation in this protocol.
- Significant cardiac or pulmonary disease (including obstructive pulmonary disease).
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication.
- Inability to comply with study and follow-up procedures.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Columbia University Medical Center
New York, New York, 10032
Stanford University
Palo Alto, California, 94304
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: An Open-Label Pilot Study of ACTH in the Treatment of IgA Nephropathy at High Risk of Progression
This study is designed to answer whether patients with progressive IgA nephropathy, who receive Acthar (ACTH) gel injection at a dose of 80 units subcutaneously twice weekly for 6 months is effective in inducing improvement in proteinuria and renal function.
- Conditions
- Progressive IgA Nephropathy, Proteinuria
- Being tested
- ACTH (Acthar) Gel
- Keywords
- ACTH, Acthar, IgA, Progressive, Nephropathy, renal function
- Medical subject headings
- Proteinuria, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTH (Acthar) GelDrug
Injected dose of 80 units subcutaneously twice weekly for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| ACTH Gel | Experimental | Injected does of 80 units subcutaneously twice weekly for 6 months. Receives: Drug: ACTH (Acthar) Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With a Complete or Partial Response to Treatment
A complete response is defined by <300 mg proteinuria/24 hours and no greater than a 10% reduction in glomerular filtration rate (GFR) as determined by quantified creatinine clearance.
A partial response is defined by >50% reduction in 24 hour proteinuria and no greater than a 25% reduction in baseline GFR as quantified creatinine clearance.
No response is defined by < or equal to 50% reduction, unchanged or increasing proteinuria over baseline levels and a greater than a 25% reduction in baseline GFR as quantified creatinine clearance.
Measured: 12 Months
Secondary outcomes (1)
Number of Subjects to Develop an Infection
The number of subjects with infections was defined as the development of pneumonia or complicated urinary tract infection/Pyelonephritis
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 posted5 Nov 2014 (estimated)
- Study startMar 2015
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Progressive IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Principal investigator, Fernando Fervenza, Mayo Clinic
- Investigators
- Fernando Fervenza, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282930
- Sponsor's protocol ID
- 14-006965
- Status last verified
- Jun 2019
- First submitted
- 31 Oct 2014
- Last updated
- 26 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study of ACTH in the Treatment of IgA Nephropathy at High Risk of Progression
- ClinicalTrials.gov ID
- NCT02282930
- Acronym / sponsor ID
- 14-006965
- Conditions
- Progressive IgA Nephropathy, Proteinuria
- Keywords
- ACTH, Acthar, IgA, Progressive, Nephropathy, renal function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Mar 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Posted 26 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to answer whether patients with progressive IgA nephropathy, who receive Acthar (ACTH) gel injection at a dose of 80 units subcutaneously twice weekly for 6 months is effective in inducing improvement in proteinuria and renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACTH Gel | Experimental | Drug: ACTH (Acthar) GelInjected does of 80 units subcutaneously twice weekly for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Proteinuria > 1000 mg/24h despite documented ACEi/ARB therapy and adequate blood pressure control for > 3 months.
- Quantified 24h creatinine clearance > 30 ml/min/1.73m2.
- Blood pressure < 130/80 mmHg at > 75% of the readings.
- Henoch Schoenlein Purpura (HSP): Patients with biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein Purpura will be considered eligible for the study.
- Patient must be able to receive injections to be enrolled in the study.
Key exclusion criteria (24 listed)
- Clinical and histologic evidence of IgA predominant Lupus nephritis
- Patients with greater than 50% glomerular senescence or cortical scarring on renal biopsy.
- Serum Cr > 3.0 mg/dL or creatinine clearance glomerular filtration rate (GFR) < 30 ml/min at the time of screening
- Patients with history of Crohn's disease or Celiac Sprue
- Clinical evidence of cirrhosis, chronic active liver disease.
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 |
|---|---|---|
| ACTH (Acthar) GelInjected dose of 80 units subcutaneously twice weekly for 6 months. | Drug | ACTH Gel |
Primary outcome
Number of Subjects With a Complete or Partial Response to Treatment
Time frame: 12 Months
A complete response is defined by <300 mg proteinuria/24 hours and no greater than a 10% reduction in glomerular filtration rate (GFR) as determined by quantified creatinine clearance. A partial response is defined by >50% reduction in 24 hour proteinuria and no greater than a 25% reduction in baseline GFR as quantified creatinine clearance. No response is defined by < or equal to 50% reduction, unchanged or increasing proteinuria over baseline levels and a greater than a 25% reduction in baseline GFR as quantified creatinine clearance.
1 secondary outcome
Number of Subjects to Develop an Infection
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Progressive IgA Nephropathy
Active, not recruitingPhase 3
Atrasentan in Patients With IgA Nephropathy
IgA Nephropathy, Immunoglobulin A Nephropathy
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.
Fernando Fervenza, MD, PhD principal investigator
Mayo Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ACTH (Acthar) Gel in people with Progressive IgA Nephropathy and Proteinuria, run by Mayo Clinic at 4 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 6 inclusion and 24 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: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With a Complete or Partial Response to Treatment (time frame: 12 Months). 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 26 Jun 2019.