BridgeMD
An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC‑MPGN
EU CTIS ID: 2024-511544-36-00
What this study is testing
To evaluate the efficacy of pegcetacoplan in improving the underlying pathophysiology of complement 3 glomerulopathy (C3G)/immune complex membranoproliferative lomerulonephritis (IC-MPGN) after 12 weeks of treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- At least 18 years of age at screening
- Willing and able to provide written informed consent
- Able to understand and willing to comply with all scheduled procedures and other requirements of the study in the opinion of the investigator
- Willing and able to self-administer pegcetacoplan or have an identified caregiver who can perform the administration
- Must have clinical and pathologic evidence of recurrent C3G or ICMPGN, 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)
- Stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months preceding the first dose of pegcetacoplan
You likely can't join if
- Absolute neutrophil count <1000 cells/mm3 during screening (not including Day 1)
- 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
- Women who are pregnant, or who are currently breastfeeding
- 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
- Evidence of drug or alcohol abuse or dependence, in the opinion of the investigator
- Known or suspected hereditary fructose intolerance.
See the full eligibility criteria
Who can join
- At least 18 years of age at screening
- Willing and able to provide written informed consent
- Able to understand and willing to comply with all scheduled procedures and other requirements of the study in the opinion of the investigator
- Willing and able to self-administer pegcetacoplan or have an identified caregiver who can perform the administration
- Must have clinical and pathologic evidence of recurrent C3G or ICMPGN, 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)
- Stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months preceding the first dose of pegcetacoplan
- eGFR ≥15 mL/min/1.73 m2, calculated by the Chronic Kidney Disease–Epidemiology Collaboration (CKD-EPI) creatinine equation for adults
- No more than 50% glomerulosclerosis or interstitial fibrosis on the screening renal allograft biopsy
- 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
- Have received required vaccinations against N. meningitidis, 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 exists that subjects are nonresponders to vaccination.
- Women of childbearing potential, defined as any women who have experienced menarche and who are not permanently sterile or postmenopausal, must each have a negative blood pregnancy test at screening (and negative urine pregnancy at Visit 4) and must agree to use protocol-defined methods of contraception from screening through 12 weeks after receiving last dose of pegcetacoplan
- 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
What rules you out
- Absolute neutrophil count <1000 cells/mm3 during screening (not including Day 1)
- 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
- Women who are pregnant, or who are currently breastfeeding
- 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
- Evidence of drug or alcohol abuse or dependence, in the opinion of the investigator
- Known or suspected hereditary fructose intolerance.
- Previous treatment with pegcetacoplan
- Evidence of rejection on the screening renal allograft biopsy that requires treatment
- Diagnosis or history of HIV, hepatitis B, or hepatitis C infection or positive serology at screening indicative of infection with any of these viruses
- Weight more than 100 kg at screening
- Hypersensitivity to pegcetacoplan or any of the excipients
- History of meningococcal disease
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Argentina
- Australia
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Argentina; Australia; Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.