Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OM… (NCT02682407) | Clinical Trial Compass
TerminatedPhase 2
Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721
Stopped: Study terminated by Sponsor
United States31 participantsStarted 2016-03-10
Plain-language summary
The purpose of this study was to evaluate the safety and tolerability of OMS721 (narsoplimab) in participants with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), Membranous Nephropathy (MN), and Complement Component 3 Glomerulopathy (C3G) including Dense Deposit Disease. The study will also evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), anti-drug antibody response (ADA), and neutralizing antibodies (NAb) of narsoplimab when administered intravenously and when administered both intravenously and subcutaneously in participants of Asian descent with IgA Nephropathy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Have a diagnosis of one of the following:
✓. Have 24-hour urine protein \> 1000 mg/24 hours.
✓. Are age \>= 18 years at Screening Visit 1 and (for Cohort 4 only) are of Asian descent.
✓. Have documented history of 24-hour urine protein \> 1 g within 6 months prior to Screening or Urine Protein Creatinine Ratio (uPCR) \> 0.75 by spot urine at Screening (Cohort 4 only).
✓. Have an eGFR \> 30 mL/min/1.73 m\^2 calculated by the Chronic Kidney Disease Epidemiology (CKD-EPI) equation at Screening (Cohort 4).
✓. Are on physician-directed, stable, optimized treatment with ACEIs and/or ARBs and have a systolic BP of \< 150 mmHg and a diastolic BP of \< 90 mmHg at rest.
✓. If female, are either a) not of childbearing potential (i.e., surgically sterilized or postmenopausal for \> 1 year), b) have a negative pregnancy test at Screening and baseline and if sexually active must agree to use 2 medically reliable forms of contraception throughout the study (all Cohorts) and for at least 12 weeks after the last dose of study drug, including possible extended treatments (Cohort 4), or c) have a medically sterilized male partner. Acceptable methods of contraception include a reliable intrauterine device, hormonal contraception, or a barrier method.
✓
What they're measuring
1
Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy Participants With Treatment Related Adverse Events (AE).
Timeframe: up to 104 weeks
2
Cohort 4: Proportion of IgAN Participants of Asian Descent With Treatment Related AEs.
Timeframe: 38 weeks
3
Cohort 4: Change From Baseline in Serum and Urine Complement Component Levels.
. If male having heterosexual intercourse, are either a) not of reproductive potential or b) if sexually active must agree to use a medically reliable form of contraception throughout the study (all Cohorts) and for at least 12 weeks after the last dose of study drug, including possible extended treatments (Cohort 4). Acceptable methods of birth control include spermicide in combination with a barrier method, or subject's female partner is willing to use medically acceptable methods of birth control (intrauterine device, hormonal contraception, or a barrier method).
Exclusion criteria
✕. Have a known hypersensitivity to any constituent of the investigational product.
✕. Have a hemoglobin \< 9.0 g/dL.
✕. Have a platelet count \< 100,000/mm\^3.
✕. Have an absolute neutrophil count \< 500 cells/mm\^3.
✕. Have an alanine aminotransferase or aspartate aminotransferase \> 5.0 x the upper limit of normal.
✕. Have systemic manifestations of Henoch-Schonlein purpura (e.g., joint pain, gastrointestinal bleeding, abdominal pain) within 2 years prior to Screening Visit 1.
✕. Have used belimumab, eculizumab, or rituximab within 6 months of Screening Visit 1.
✕. Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), or cytotoxic drugs, for IgAN within 8 weeks prior to Screening. Treatment with immunosuppressants or cytotoxic drugs for IgAN is not allowed during the Run-In Period. Treatment with immunosuppressants are allowed if such treatment is for indications other than IgAN(Cohort 4 only).