Study to Evaluate the Safety, Tolerability of BCX9930 in Participants With Either Complement 3 Glomerulopathy (C3G), Immunoglobulin A Nephropathy (IgAN), or Primary Membranous Nephropathy (PMN)
Complement 3 Glomerulopathy · Immunoglobulin A Nephropathy · Membranous Nephropathy
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 2
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 2 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
Sponsor Decision
About the research
The objective of this study was to determine the safety and therapeutic potential of BCX9930 in participants with C3G, IgAN, or PMN.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Body weight ≥ 40 kilograms (kg)
- Primary diagnosis of C3G, IgAN, or PMN confirmed by central pathology review
- An estimated glomerular filtration rate (eGFR) ≥ 50 milliter per minute per 1.73 meter square (mL/min/1.73 m\^2) (or ≥ 30 mL/min/1.73 m\^2 after Data Monitoring Committee \[DMC\] recommendation)
- Receiving treatment with a stable, maximum recommended or maximum tolerated dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 60 days prior to the Day 1 Visit
- Documentation of current vaccinations against Neisseria meningitidis and Streptococcus pneumoniae or willingness to start vaccination series
Exclusion Criteria:
- Known congenital deficiency of C1s, C1r, C1q, C2, or C4
- History of hematopoietic cell transplant or solid organ transplant or anticipated candidate for transplantation
- Myocardial infarction or cerebrovascular accident within 30 days prior to screening, or current and uncontrolled clinically significant cardiovascular or cerebrovascular condition
- History of malignancy within 5 years prior to the screening visit
- Active serious bacterial, viral, or fungal infection or any other serious infection within 14 days of screening
- Treatment with any systemic immunosuppressive or immunomodulatory therapy within 90 days OR anti-CD20 antibody therapies (eg, rituximab) within 180 days prior to the screening visit
- Treatment with renin inhibitors (eg, aliskiren) or sodium-glucose-cotransporter 2 (SGLT2) inhibitors within 60 days prior to Day 1
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- No masking
C3G cohort
Approximately 14 eligible participants with C3G will be enrolled.
Drug: BCX9930
IgAN cohort
Approximately 14 eligible participants with IgAN will be enrolled.
Drug: BCX9930
PMN cohort
Approximately 14 eligible participants with PMN will be enrolled.
Drug: BCX9930
BCX9930 DRUG
Administered orally at a dose of 200 mg twice daily for the first 2 weeks, then 400 mg twice daily
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Percent Change From Baseline in 24-hour uPCR at Week 12
Time frame: Baseline, Week 12
Urinary protein/creatinine ratio (mg/mmol) =urine protein concentration (mg/dL)/ urine creatinine concentration (mmol/dL). Decrease of urinary protein/creatinine ratio means improvement of renal disease.
Percent Change From Baseline in 24-hour uPCR at Week 24
Time frame: Baseline, Week 24
Urinary protein/creatinine ratio (mg/mmol) =urine protein concentration (mg/dL)/ urine creatinine concentration (mmol/dL). Decrease of urinary protein/creatinine ratio means improvement of renal disease.
Secondary measures
Percent Change From Baseline in 24-hour Urinary Protein Excretion
Time frame: Baseline, Weeks 12, 24,
Not reported in this registry record.
Change From Baseline in Estimated Glomerular Filtration Rate
Time frame: Baseline, Weeks 12, 24
eGFR was calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula for participants ≥ 18 years old and by the bedside Schwartz formula for participants ≤ 18 years old. eGFR was reported in milliliter per minute per 1.73 per square meter (mL/min/1.73m\^2).
Number of Participants With a Treatment-emergent Adverse Event (TEAE)
Time frame: From first dose up to safety follow-up period (Week 28)
An Adverse event (AE) was any untoward medical occurrence in a clinical study participant. TEAEs were defined, within a dosing group, as AEs that started on or after the first dose of study treatment through 30 days after the last dose of study drug.
Number of Participants Who Discontinued Due to a TEAE
Time frame: From first dose up to safety follow-up period (Week 28)
An AE was any untoward medical occurrence in a clinical study participant. TEAEs were defined, within a dosing group, as AEs that started on or after the first dose of study treatment through 30 days after the last dose of study drug.
Number of Participants Who Experienced a Treatment-emergent Serious Adverse Event (TESAE)
Time frame: From first dose up to safety follow-up period (Week 28)
An AE was any untoward medical occurrence in a clinical study participant. TEAEs were defined, within a dosing group, as AEs that started on or after the first dose of study treatment through 30 days after the last dose of study drug.
A serious adverse event (SAE) was an adverse event/reaction that results in any of the following outcomes:
- Death
- Is life-threatening (participant was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if it were more severe)
- Requires participant hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity (ie, there was a substantial disruption of a person's ability to carry out normal life functions)
- Is a congenital anomaly/birth defect
Number of Participants Who Experienced a Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 TEAE
Time frame: From first dose up to safety follow-up period (Week 28)
An AE was any untoward medical occurrence has no causal relationship with the study drug or with the clinical study itself. It was an unfavorable \& unintended sign, symptom, syndrome, or illness that developed or worsened during clinical study.
TEAEs: AEs that started on or after first dose of treatment through 30 days after the last dose of study drug. All AEs were graded using the CTCAE Grades 1 through 5.
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL)
Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL
Grade 4: Life-threatening consequences; urgent intervention indicated
Grade 5: Death
Participants with Grades 3 or 4 AEs were reported
Number of Participants Who Experienced a CTCAE Treatment-emergent Grade 3 or 4 Laboratory Abnormality
Time frame: From first dose up to safety follow-up period (Week 28)
Treatment-emergent Laboratory Abnormality were defined as an event that started on or after the first dose of study treatment through 30 days after the last dose of study drug.
CTCAE Grades for laboratory abnormalities include:
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.
Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.
Grade 4: Life-threatening consequences; urgent intervention indicated.
Grade 5: Death
Participants with Grades 3 or 4 laboratory abnormality were reported.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (11)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
11 locations
Investigative SitePoitiers, FranceStatus unknown
Investigative SiteToulouse, FranceStatus unknown
Investigative SiteBari, ItalyStatus unknown
Investigative SiteBergamo, ItalyStatus unknown
Investigative SiteBrescia, ItalyStatus unknown
Investigative SiteTurin, ItalyStatus unknown
Investigative Site #1Barcelona, SpainStatus unknown
Investigative Site #2Barcelona, SpainStatus unknown
Investigative Site #1Madrid, SpainStatus unknown
Investigative Site #2Madrid, SpainStatus unknown
Investigative SiteOxford, United KingdomStatus unknown
Study team and timeline
- Lead sponsor
- BioCryst Pharmaceuticals
- Study start
- Feb 18, 2022 Actual
- Primary completion
- Sep 23, 2022 Actual
- Study completion
- Sep 23, 2022 Actual
- First posted
- Dec 17, 2021 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects With Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026