Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPG
- Conditions
- complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2020-002637-15-NL
- Lead Sponsor
- Apellis Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 12
Individuals must meet all of the following criteria at screening visits to be included in the study:
1. At least 18 years of age at screening
2. Must have clinical and pathologic evidence of recurrent C3G or IC-MPGN, as evidenced by all of the following:
a. A diagnosis of C3G or IC-MPGN, with at least 2+ staining for C3c in the renal allograft, confirmed by a central pathologist, based on the screening renal allograft biopsy
b. C3G or IC-MPGN must be primary and not secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, autoimmunity, chronic antibody-mediated rejection, chronic thrombotic microangiopathy, or a medication)
3. Stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months preceding the first dose of pegcetacoplan
4. eGFR =15 mL/min/1.73 m2, calculated by the Chronic Kidney Disease–Epidemiology Collaboration (CKD-EPI) creatinine equation for adults
5. No more than 50% glomerulosclerosis or interstitial fibrosis on the screening renal biopsy
6. Stable regimen for recurrent C3G/IC-MPGN for at least 4 weeks prior to the screening renal allograft biopsy and from the time of the screening renal allograft biopsy until randomization
7. Have received required vaccinations against N. meningitides, S. pneumoniae, and H. influenzae (type B) or agree to receive vaccinations if applicable vaccination records are not available, Vaccination is mandatory unless documented evidence exist that subjects are nonresponders to vaccination
8. Women of childbearing potential, defined as any women who have experienced menarche and who are not permanently sterile or postmenopausal, must have a negative blood pregnancy test at screening (and negative urine pregnancy at Visit 4) and must agree to use protocoldefined methods of contraception from screening through 12 weeks after receiving last dose of pegcetacoplan
9. Men must agree to use protocol-defined methods of contraception and agree to refrain from donating semen from screening through 12 weeks after receiving last dose of pegcetacoplan
10. Willing and able to provide written informed consent
11. Able to understand and willing to comply with all scheduled procedures and other requirements of the study in the opinion of the investigator
12. Willing and able to self-administer pegcetacoplan or have an identified caregiver who can perform the administration
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
Individuals meeting any of the following criteria at screening or baseline are ineligible to participate in this study:
1. Absolute neutrophil count <1000 cells/mm3 during screening (not including Day 1)
2. Previous treatment with pegcetacoplan
3. Evidence of rejection on the screening renal allograft biopsy that requires treatment
4. Diagnosis or history of HIV, hepatitis B, or hepatitis C infection or positive serology at screening indicative of infection with any of these viruses
5. Weight more than 100 kg at screening
6. Hypersensitivity to pegcetacoplan or any of the excipients
7. History of meningococcal disease
8. 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
9. Significant renal disease in the renal allograft secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, rejection, or a medication) that would. in the opinion of the investigator, confound interpretation of the study results
10. 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 the investigational agent (whichever is longer) prior to screening period
11. Women who are pregnant, or who are currently breastfeeding
12. Inability to cooperate or any condition that, in the opinion of the investigator, could increase the subject’s risk by participating in the study or confound the outcome of the study
13. Evidence of drug or alcohol abuse or dependence, in the opinion of the investigator
14. Known or suspected hereditary fructose intolerance
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method