Skip to main content
Update Location

My Location

Update your location to show providers, locations, and services closest to you.

Enter a zip code
Or
Select a campus/region
(352) 733-0111

APL2-C3G-314

  • Status
    Accepting Candidates
  • Age
    12 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
Share this study
Facebook
Twitter
LinkedIn

Objective

This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).

Details

Full study title An Open-Label, Non-randomized, Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in Participants with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
Protocol number OCR45112
ClinicalTrials.gov ID NCT05809531
Phase Phase 3

Eligibility

Inclusion Criteria:

  • Completed participation in Study APL2-C3G-310 through the week 52 visit requirements

  • Experienced clinical benefit from pegcetacoplan while participating in the previous trial, in the opinion of the investigator

  • Must remain on a stable regimen for C3G or IC-MPGN treatment according to the requirements of Study APL2-C3G-310

  • Received vaccinations against S pneumoniae, N meningitidis (types A, C, W, Y, and B), and H influenzae (type B) according to the requirements of Study APL2-C3G-310 and agree to receive any additional vaccinations recommended according to ACIP recommendations for adults or children with complement deficiencies and/or immunocompromising conditions or other similar local applicable guidelines

  • Female participants of childbearing potential, defined as any woman who has experienced menarche and who is not permanently sterile or postmenopausal, must have a negative urine pregnancy test at visit 1 and must agree to use protocol-defined methods of contraception for the duration of the study through at least 90 days after receiving the last dose of pegcetacoplan

  • Male participants must agree to use protocol-defined methods of contraception and agree to refrain from donating semen for the duration of the study through at least 90 days after receiving the last dose of pegcetacoplan

  • Participants above the legal age of consent, in accordance with local regulations, must be willing and able to provide informed consent. The legally authorized representative of participants under the legal age of consent must be willing and able to provide informed consent; where appropriate, participants under the legal age of consent must also give their assent to participation in the study

  • Willing and able to self-administer pegcetacoplan or have an identified caregiver who can perform the administration

Exclusion Criteria:

  • Female participants who are or are planning to become 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

  • Inability or unwillingness to cooperate with the requirements of the protocol

  • 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

  • Evidence of ongoing drug or alcohol abuse or dependence, in the opinion of the investigator

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Lawrence Shoemaker
  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.