Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy

NCT02605525 | Withdrawn Phase 2 DMC

• 2 other identifiers: 1815012015-002345-64
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Keywords

IgAN

Outcome Measures

Primary Outcomes (1)

• Percent change in proteinuria from Baseline to Week 24

  Baseline and Week 24

Secondary Outcomes (18)

• Number of participants who demonstrate a ≥30% reduction from Baseline in proteinuria

  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

  Week 8, Week 12, Week 18, and Week 24

• Mean change from Baseline in Estimated glomerular filtration rate (eGFR)

  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

  Throughout the study period of approximately 19 months

• Number of participants who experience serious adverse events (SAEs) or adverse events (AEs)

  Throughout the study period of approximately 19 months

Study Arms (3)

SM101 12 mg/kg

EXPERIMENTAL

Human soluble recombinant Fcγ Receptor IIB

Biological: SM101

SM101 24 mg/kg

EXPERIMENTAL

Human soluble recombinant Fcγ Receptor IIB

Biological: SM101

Placebo

PLACEBO COMPARATOR

L-histidine-buffered saline with mannitol, sucrose, and polysorbate 2

Other: Placebo

Interventions

SM101 BIOLOGICAL

Human soluble recombinant Fcγ Receptor IIB

Also known as: BAX1810, BAX 1810

SM101 12 mg/kg; SM101 24 mg/kg

Placebo OTHER

L-histidine-buffered saline with mannitol, sucrose, and polysorbate 20

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Baxalta now part of Shire: lead

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 16, 2015
• Study Start: December 31, 2015
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: February 7, 2022

Record last verified: 2021-04