Immunoglobulin A NephropathyPhase 2NCT02605525
Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy
A Phase 2 study testing SM101 in people with Immunoglobulin A Nephropathy, run by Baxalta now part of Shire.
Trial summary
The purpose of this study is to assess the efficacy and safety of SM101 in the treatment of Immunoglobulin A nephropathy (IgAN) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunoglobulin A Nephropathy
- What is being tested?
- SM101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2015to 30 Nov 2016
- Phase
- Phase 2
- 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
- 18 years of age or older at the time of screening
- Participant may be of any race or ethnicity
- Participant must have a biopsy-proven diagnosis of IgAN.
- Participant's blood pressure is ≤130/80 mmHg at Screening
- Participant is on maximally tolerated dose of an angiotensin-converting enzyme (ACE) inhibitor and/or angiotensin receptor blocker (ARB) for at least 3 months prior to the baseline visit.
- Participant must present at screening with current proteinuria levels between 1 g/24 h and 3.5 g/24 h, based on spot urine protein-to-creatinine ratio (UPCR)
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- Participant must present at screening with an estimated glomerular filtration rate (eGFR) >40mL/min/1.73m^2
- If a female of childbearing potential, participant must have a negative pregnancy test at screening, is not currently breastfeeding, and agrees to employ adequate birth control measures for the duration of the study. Male participants with female partners of childbearing potential must agree to use adequate birth control measures for the duration of the study
- Participant is willing and able to comply with the requirements of this protocol and agrees to sign an informed consent form prior to any study-related activities
Who cannot join
- Participant has a history or current evidence of renal disease other than IgAN
- Participants with evidence of rapidly progressive disease
- Participant has IgAN with histologic evidence of advanced tubular atrophy and interstitial
- History or current evidence of other autoimmune disease
- History or current evidence of any chronic or uncontrolled medical condition which could, in the opinion of the Investigator, affect the participant's safety and ability to adhere to this protocol
- History or current evidence of a severe acute or chronic infection
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- Use of systemic corticosteroids within 3 months prior to baseline, or anticipated use during the treatment period (Week 1 through Week 4). Note: Corticosteroids administered by inhalation or intranasally, or limited topical use of low-potency topical corticosteroids are allowed throughout the study.
- Known hypersensitivity or allergic reaction to any E. coli-derived recombinant product, yeast extract, or to the IP or any of its excipients
- Treatment with any immunomodulatory/immunosuppressive compound or monoclonal antibody for any indication within 6 months (unless otherwise stated) prior to screening (eg, B cell-depleting agents [eg, rituximab, epratuzumab] for ≥48 weeks; B-cell modifying agents [eg, belimumab, atacicept] for ≥24 weeks; IV immunoglobulins for ≥12 weeks and all other immunosuppressive treatments [eg, methotrexate, cyclophosphamide, cyclosporine, tacrolimus, mycophenolate mofetil, azathioprine] for ≥12 weeks)
- Clinically significant laboratory abnormalities prior to baseline
- History of any malignancy within past 5 years prior to screening (except for basal and squamous cell carcinomas of the skin, in situ cervical cancer, and stable prostate cancer that does not require treatment)
- History of tonsillectomy within 2 months prior to screening
- Participation in another clinical study involving an IP or investigational device within 30 days prior to screening or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
- Participant is a family member or employee of the Investigator
- A female participant who is pregnant or nursing at the time of screening
About this study
Official title: A Phase 2 Study to Assess the Efficacy and Safety of Intravenous Infusion With Human Soluble Recombinant Fc-gamma Receptor IIB (SM101/BAX 1810) in Subjects With Immunoglobulin A Nephropathy (IgAN)
The purpose of this study is to assess the efficacy and safety of SM101 in the treatment of Immunoglobulin A nephropathy (IgAN)
- Conditions
- Immunoglobulin A Nephropathy
- Being tested
- SM101, Placebo
- Keywords
- IgAN
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM101Biological
Also called BAX1810, BAX 1810
Human soluble recombinant Fcγ Receptor IIB
PlaceboOther
L-histidine-buffered saline with mannitol, sucrose, and polysorbate 20
| Study group | Role | What they receive |
|---|---|---|
| SM101 12 mg/kg | Experimental | Human soluble recombinant Fcγ Receptor IIB Receives: Biological: SM101 |
| SM101 24 mg/kg | Experimental | Human soluble recombinant Fcγ Receptor IIB Receives: Biological: SM101 |
| Placebo | Placebo comparator | L-histidine-buffered saline with mannitol, sucrose, and polysorbate 2 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in proteinuria from Baseline to Week 24
Measured: Baseline and Week 24
Secondary outcomes (18)
Number of participants who demonstrate a ≥30% reduction from Baseline in proteinuria
Measured: Baseline, Week 8, Week 12, Week 18, and Week 24
Number of participants who reach and maintain proteinuria levels below 1.0 g/24 h
Measured: Week 8, Week 12, Week 18, and Week 24
Mean change from Baseline in Estimated glomerular filtration rate (eGFR)
Measured: Baseline, Week 8, Week 12, Week 18, and Week 24
Number of participants who experience any treatment-related serious adverse event (SAE) or severe adverse events (AE) during the course of the treatment period or subsequent follow-up period
Measured: Throughout the study period of approximately 19 months
Number of participants who experience serious adverse events (SAEs) or adverse events (AEs)
Measured: Throughout the study period of approximately 19 months
Number of participants who experience temporally-related adverse events (AEs)
Temporally-related AEs - defined as AEs occurring during investigational product (IP) administration or within 72 hours of IP administration, regardless of causality
Measured: Baseline through 72 hours of IP administration
Number of participants with any clinically significant change in vital signs during investigational product (IP) administration or within 30 minutes following administration
Measured: Baseline through 30 minutes following IP administration
Number of infusions associated with adverse events (AEs) or serious adverse events (SAEs) , regardless of causality
Measured: Throughout the study period of approximately 19 months
Number of infusions that had to be slowed, interrupted, or terminated due to adverse events (AEs) or serious adverse events (SAEs)
Measured: Throughout the study period of approximately 19 months
Number of participants with detectable levels of antidrug antibodies (ADAs)
Measured: Baseline, Week 3, Week 4, Week 12, Week 24, or early termination from the study
Clinically significant abnormal laboratory assessments
Measured: Throughout the study period of approximately 19 months
Pharmacokinetics: maximum observed concentration (Cmax)
Measured: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: time of maximum observed concentration (Cmax)
Measured: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: area under the concentration-time curve during a dosing interval (AUC(0-tau))
Measured: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: terminal half-life (t1/2)
Measured: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: systemic clearance (CL)
Measured: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: volume of distribution at the terminal phase (Vz)
Measured: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: volume of distribution at steady state (Vss)
Measured: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study start31 Dec 2015
- Primary completion30 Nov 2016 (estimated)
- Study completion30 Nov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin A NephropathyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605525
- Sponsor's protocol ID
- 181501
- Other IDs
- 2015-002345-64, 2015
- Status last verified
- Apr 2021
- First submitted
- 12 Nov 2015
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Assess the Efficacy and Safety of Intravenous Infusion With Human Soluble Recombinant Fc-gamma Receptor IIB (SM101/BAX 1810) in Subjects With Immunoglobulin A Nephropathy (IgAN)
- ClinicalTrials.gov ID
- NCT02605525
- Acronym / sponsor ID
- 181501
- Conditions
- Immunoglobulin A Nephropathy
- Keywords
- IgAN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2015 (actual)
- Primary completion
- 30 Nov 2016 (estimated)
- Study completion
- 30 Nov 2016 (estimated)
- First posted
- 16 Nov 2015 (estimated)
- 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.
The purpose of this study is to assess the efficacy and safety of SM101 in the treatment of Immunoglobulin A nephropathy (IgAN)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SM101 12 mg/kg | Experimental | Biological: SM101Human soluble recombinant Fcγ Receptor IIB |
| SM101 24 mg/kg | Experimental | Biological: SM101Human soluble recombinant Fcγ Receptor IIB |
| Placebo | Placebo comparator | Other: PlaceboL-histidine-buffered saline with mannitol, sucrose, and polysorbate 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older at the time of screening
- Participant may be of any race or ethnicity
- Participant must have a biopsy-proven diagnosis of IgAN.
- Participant's blood pressure is ≤130/80 mmHg at Screening
- Participant is on maximally tolerated dose of an angiotensin-converting enzyme (ACE) inhibitor and/or angiotensin receptor blocker (ARB) for at least 3 months prior to the baseline visit.
Key exclusion criteria (15 listed)
- Participant has a history or current evidence of renal disease other than IgAN
- Participants with evidence of rapidly progressive disease
- Participant has IgAN with histologic evidence of advanced tubular atrophy and interstitial
- History or current evidence of other autoimmune disease
- History or current evidence of any chronic or uncontrolled medical condition which could, in the opinion of the Investigator, affect the participant's safety and ability to adhere to this protocol
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 |
|---|---|---|
| SM101Also: BAX1810, BAX 1810Human soluble recombinant Fcγ Receptor IIB | Biological | SM101 12 mg/kg, SM101 24 mg/kg |
| PlaceboL-histidine-buffered saline with mannitol, sucrose, and polysorbate 20 | Other | Placebo |
Primary outcome
Percent change in proteinuria from Baseline to Week 24
Time frame: Baseline and Week 24
18 secondary outcomes
Number of participants who demonstrate a ≥30% reduction from Baseline in proteinuria
Time frame: Baseline, Week 8, Week 12, Week 18, and Week 24
Number of participants who reach and maintain proteinuria levels below 1.0 g/24 h
Time frame: Week 8, Week 12, Week 18, and Week 24
Mean change from Baseline in Estimated glomerular filtration rate (eGFR)
Time frame: Baseline, Week 8, Week 12, Week 18, and Week 24
Number of participants who experience any treatment-related serious adverse event (SAE) or severe adverse events (AE) during the course of the treatment period or subsequent follow-up period
Time frame: Throughout the study period of approximately 19 months
Number of participants who experience serious adverse events (SAEs) or adverse events (AEs)
Time frame: Throughout the study period of approximately 19 months
Number of participants who experience temporally-related adverse events (AEs)
Time frame: Baseline through 72 hours of IP administration
Number of participants with any clinically significant change in vital signs during investigational product (IP) administration or within 30 minutes following administration
Time frame: Baseline through 30 minutes following IP administration
Number of infusions associated with adverse events (AEs) or serious adverse events (SAEs) , regardless of causality
Time frame: Throughout the study period of approximately 19 months
Number of infusions that had to be slowed, interrupted, or terminated due to adverse events (AEs) or serious adverse events (SAEs)
Time frame: Throughout the study period of approximately 19 months
Number of participants with detectable levels of antidrug antibodies (ADAs)
Time frame: Baseline, Week 3, Week 4, Week 12, Week 24, or early termination from the study
Clinically significant abnormal laboratory assessments
Time frame: Throughout the study period of approximately 19 months
Pharmacokinetics: maximum observed concentration (Cmax)
Time frame: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: time of maximum observed concentration (Cmax)
Time frame: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: area under the concentration-time curve during a dosing interval (AUC(0-tau))
Time frame: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: terminal half-life (t1/2)
Time frame: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: systemic clearance (CL)
Time frame: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: volume of distribution at the terminal phase (Vz)
Time frame: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: volume of distribution at steady state (Vss)
Time frame: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
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 7 Feb 2022.
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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.
Study Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SM101 in people with Immunoglobulin A Nephropathy, run by Baxalta now part of Shire.
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 15 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 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percent change in proteinuria from Baseline to Week 24 (time frame: Baseline and Week 24). 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 7 Feb 2022.