NL-OMON55956招募中3 期
A phase 3, randomized, placebo-controlled, double-blinded, multicenter study to evaluate the efficacy and safety of pegcetacoplan in patients with C3 glomerulopathy or immune-complex membranoproliferative glomerulonephritis - VALIANT
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 99（—）
入选标准
- •1. Aged at least 18 years; where approved, adolescents (aged 12-17 years)
- •weighing at least 30 kg
- •may also be enrolled.
- •2. A diagnosis of primary C3G or IC-MPGN (with or without previous renal
- •transplant).
- •3. Evidence of active renal disease, based on one or more of the following:
- •a. In adults or adolescents with a baseline renal biopsy (either one collected
- •during screening or a historic biopsy collected within 28 weeks prior to
- •randomization), at least 2+ C3c staining on the baseline renal biopsy.
- •b. In adolescents not providing a baseline renal biopsy, at least one of the
- •- Plasma sC5b-9 level above the upper limit of normal during screening
- •- Serum C3 below the LLN during screening
- •- Presence of an active urine sediment during screening, as evidenced by
- •hematuria with at least 5 red blood cells per high-power field and/or red blood
- •cell casts on routine local or central microscopic analysis of urine
- •- Presence of C3 nephritic factor within 6 months of screening, based on
- •central laboratory results or medical history
- •4. No more than 50% global glomerulosclerosis or interstitial fibrosis on the
- •baseline biopsy for adult participants or adolescent participants providing a
- •baseline biopsy.
- •5. At least 1 g/day of proteinuria on a screening 24-hour urine collection and
- •a uPCR of at least 1000 mg/g in at least 2 first-morning spot urine samples
- •collected during screening.
- •6. eGFR >=30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease-
- •Epidemiology Collaboration creatinine equation for adults or the Bedside
- •Schwartz equation for adolescents.
- •7. Stable regimen for C3G/IC-MPGN treatment, as described below:
- •a. Angiotensin-converting enzyme inhibitor, angiotensin receptor blocker,
- •and/or sodium-glucose cotransporter-2 inhibitor therapy that is stable and
- •optimized, in the opinion of the investigator, for at least 12 weeks prior to
- •randomization
- •b. Stable doses of other medications that can affect proteinuria (eg, steroids,
- •mycophenolate mofetil, and/or other allowed immunosuppressants that the
- •participant is receiving for treatment of C3G or IC-MPGN) for at least 12 weeks
- •prior to randomization.
- •c. If a participant is on prednisone (or other systemic corticosteroid) for C3G
- •or IC-MPGN treatment, the dosage is stable and no higher than 20 mg/day (or
- •equivalent dosage of a corticosteroid other than prednisone) for at least 12
- •weeks prior to randomization.
- •8. Have received vaccinations against S pneumoniae, N meningitidis (types A, C,
- •W, Y, and B), and H influenzae (type B) as per ACIP recommendations for adults
- •or children with complement deficiencies. Vaccination series should be
- •initiated at least 14 days prior to randomization. Vaccination is mandatory
- •unless documented evidence exists that participants are nonresponders to
- •vaccination.
- •9. Female participants of childbearing potential, defined as any women who have
- •experienced menarche and who are not permanently sterile or postmenopausal,
- •must have negative blood pregnancy tests at screening (and negative urine
- •pregnancy tests on Day 1) and must agree to use protocol-defined methods of
- •contraception from screening through at least 90 days after receiving the last
- 另有 3 项未显示
排除标准
- •1. Previous exposure to pegcetacoplan.
- •2. Evidence of improving renal disease in the 8 weeks prior to screening or
- •during the screening period according to available data; improving renal
- •disease is defined as >30% increase in eGFR or >50% decrease in proteinuria.
- •3. From a renal transplant subject, evidence of rejection that requires
- •treatment in the baseline renal biopsy collected during screening.
- •4. C3G/IC-MPGN secondary to another condition (eg, infection, malignancy,
- •monoclonal gammopathy, a systemic autoimmune disease such as systemic lupus
- •erythematosus, chronic antibody-mediated rejection, or a medication), in the
- •opinion of the investigator.
- •5. Current or prior diagnosis of HIV, hepatitis B, or hepatitis C infection or
- •positive serology during screening that is indicative of infection with any of
- •these viruses.
- •6. Weight more than 100 kg at screening.
- •7. Hypersensitivity to pegcetacoplan or to any of the excipients.
- •8. History of meningococcal disease.
- •9. Malignancy, except for the following:
- •a. Cured basal or squamous cell skin cancer
- •b. Curatively treated in situ disease
- •c. Malignancy-free and off treatment for >=5 years
- •10. Severe infection (eg, requiring IV antibiotic therapy) within 14 days prior
- •to the first dose of pegcetacoplan.
- •11. An absolute neutrophil count <1000 cells/mm3 at screening
- •12. Significant other renal disease that would, in the opinion of the
- •investigator, confound interpretation of study results.
- •13. Participation in any other investigational drug trial or exposure to other
- •investigational agent, device, or procedure within 30 days or 5 half-lives from
- •the last dose of investigational agent (whichever is longer) prior to screening
- •14. Use of rituximab, belimumab, or any approved or investigational
- •anticomplement therapy other than pegcetacoplan within 5 half-lives of that
- •product prior to the screening period.
- •15. Female participants who are pregnant or who are currently breastfeeding and
- •are unwilling to discontinue for the duration of the study and for at least 90
- •days after the final dose of study drug.
- •16. Inability to cooperate or any condition that, in the opinion of the
- •investigator, creates an undue risk for the participant by participating in the
- •study or is likely to confound interpretation of the study results.
- •17. Evidence of ongoing drug or alcohol abuse or dependence, in the opinion of
- •the investigator.
- •18. Presence or suspicion of severe infection during the screening period
- •(including but not limited to recurrent) or chronic infections that, in the
- •opinion of the investigator, may place the participant at unacceptable risk by
- •study participation.
- •19. Known or suspected hereditary fructose intolerance.
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