NOBLE: A clinical research study for people with recurrent C3G or MPGN after a kidney transplant
NOBLE is a clinical research study evaluating the safety and effectiveness of an investigational medication in adults with recurrent C3G or MPGN* in a transplanted kidney.
*C3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN or MPGN)
About the NOBLE Study
This study is evaluating the safety and effectiveness of an investigational targeted C3 inhibitor called pegcetacoplan (peg-set-a-koé-plan) in adults who have C3G or MPGN recurrence after kidney transplant.
The NOBLE study is exploring whether pegcetacoplan has an effect on the build-up of the complement protein C3 in the kidney that causes kidney damage.
You may be able to participate if you:
- Are at least 18 years old
- Have had a kidney transplant
- Are experiencing a recurrence of C3G or MPGN in the transplanted kidney, confirmed by a kidney biopsy. The kidney biopsy may be done as part of the study
- Have kidney function as indicated by an estimated glomerular filtration rate (eGFR) of at least 15 mL/min/1.73 m2
- Are willing to use contraception until at least 3 months after the last dose of investigational medication
Additional criteria will be assessed at the research site to confirm eligibility.
The NOBLE study is not for people with C3G or MPGN who:
- Are under 18 years of age
- Have not had a kidney transplant
- Have or have had hepatitis B, hepatitis C, or HIV
- Are pregnant or breastfeeding
Additional criteria will be assessed at the research site to confirm eligibility.
The investigational medication in this study is called pegcetacoplan (peg-set-a-koé-plan). It is administered via a needle under the skin (subcutaneously) twice a week, at home.
Investigational means that pegcetacoplan is not approved by any health authority for the treatment of C3G or MPGN.
In a separate study already underway, the investigational medication (pegcetacoplan) is being evaluated in people with C3G who have not had a kidney transplant. Based on the early data from that clinical trial, the decision was made to also evaluate pegcetacoplan in people with C3G or MPGN who have recurrence in a transplanted kidney.
After completing the screening period to confirm that you are able to participate in the study, you will be randomly assigned (randomised) to one of two treatment groups.
- Group 1: Will receive pegcetacoplan for the entire duration of the study (up to 1 year). There is a 3 in 4 (75%) chance of being assigned to this group.
- Group 2: Will continue on their current treatment for the first 12 weeks (3 months) of the study and then transition to receive pegcetacoplan for the remaining 40 weeks (9 months) of the study. There is a 1 in 4 (25%) chance of being assigned to this group.
While study participants will know their study treatment group assignment they will not have the option of choosing their group.
Study participants who complete the 1-year study treatment period may enter a long-term extension study where they will continue receiving the investigational medication. Otherwise, they will enter an 8 week follow-up period after their last dose of the investigational medication.
Yes. Participants may have a biopsy as part of the screening for the study to confirm that they have a recurrence of C3G or MPGN unless they had a kidney biopsy within 12 weeks (3 months) of being assigned to a study treatment group and the biopsy meets the requirements of the study.
All study participants will have a kidney biopsy at Week 12 and again at Week 52 (1 year). The purpose of these biopsies is to determine whether or not the investigational medication is able to reduce damage to the kidneys caused by C3G / MPGN.
No kidney biopsies are required during the long-term extension study.
The study doctor will discuss this with you in more detail.
After completing the screening period, participation in the study will last for approximately 14 months. This includes:
- 1-year study treatment period
- 8 week follow-up period after the last dose of pegcetacoplan
Study participants who are benefiting medically from the investigational medication may be able to participate in a long-term extension study after completing the 1-year study treatment period, where they will continue receiving pegcetacoplan.
Study participants will have approximately 14 in-clinic visits during the 1-year study treatment period and 3 visits during the 8 week follow-up period. For those who join the long-term extension study, there will be in-clinic visits approximately every 3 months.
Reimbursement or pre-paid travel support may be available to study participants.
Yes, study participants will complete urine collections at home during the study. Participants will be asked to bring these to each study visit. When a collection is required but a study visit is not scheduled, a courier will be used to pick these up at your home.
All study-related tests and evaluations, and investigational medication will be provided at no cost to study participants. The study team can provide more detailed information. In addition, reimbursement or pre-paid travel support may be available to study participants.
No, connecting with a site does not obligate you to participate, nor does it guarantee your eligibility to participate in the study. Participating in this or any clinical trial is completely voluntary. If you decide to participate in a research study, you are always free to withdraw at any time without any penalty or effect on your future medical care.
Should COVID-19, or restrictions related to the pandemic, affect the ability of participants to go to the clinic for study visits, the study doctor will discuss the available options with participants.
Pegcetacoplan is an investigational medication. Investigational means that pegcetacoplan is not approved by any health authority for the treatment of C3G or MPGN.
Site Locations & Contact
The NOBLE study has completed enrollment
For information about other C3G or MPGN clinical trials, speak with your physician or visit www.ClinicalTrials.gov.
To be informed about future Apellis clinical trials for C3G or MPGN, email ClinicalTrials@apellis.com.
Understanding Clinical Research
What is clinical research? What are clinical trials?
Clinical research is the process of studying diseases, and developing medications to possibly prevent, treat, or help relieve symptoms caused by different medical conditions. Before a medicine can become widely available, it must be tested in a series of clinical trials, or clinical research studies. The medicine being studied or tested in a clinical trial is called an investigational medication.
Most clinical trials recruit volunteers to participate in the study. Those volunteers are closely monitored to follow the effects of an investigational medication on their health, and that information is used by health authorities to determine if the investigational medication is safe and effective, and if it should be approved for general medical use.
How do clinical trials work?
Clinical trials usually go through 3 phases before an investigational medication can be approved for general use:
NOBLE is a Phase 2 study
Why do people participate in clinical research studies?
Clinical trial participants can have an impact on the lives of others by helping researchers advance medical science, develop treatment options, and better understand the disease.
It’s important to remember that clinical trials involve some risks:
For these reasons trial participants are screened carefully and monitored throughout the trial.
Some trial participants also feel the additional time and support they receive from study doctors and investigators during the study helps them learn more about their condition. Whatever the motivation for joining a study, participation is entirely voluntary, and participants can choose to leave the study at any time, for any reason, if they change their mind.Learn more about the NOBLE study, and see if it might be right for you
Understanding clinical research terms
Clinical research terminology can be intimidating. We have created this glossary of clinical trial language to help you understand some of the key terms:
|Clinical trial participants||People who voluntarily consent to take part in a clinical trial and who meet all of the eligibility criteria.|
|Eligibility Criteria||The requirements one must meet to participate in a clinical trial. These may include age, diagnosis, current and previous treatments, allergies, medical history, and other conditions.|
|Independent ethics committee (IEC) or institutional review board (IRB)||Independent committees made up of medical experts and the general public, who review, approve, and monitor all aspects of clinical research studies involving people. These groups ensure study protocols adhere to all relevant regulations, and that the rights and welfare of all participants are protected.|
|Informed Consent Form (ICF)||An important written document that is part of a larger consent discussion with the study team. The ICF describes the study, including study-related procedures, timelines, and potential risks and benefits. By signing the ICF, patients agree to participate. Parents or guardians must sign for minors to participate in a clinical trial, however the child may be asked to sign a simplified “Assent Form” to show they understand what is being asked of them and that they are participating voluntarily.|
|Investigational medication or drug||The drug or medicine being studied in a clinical trial. Typically, this medication is not yet approved for general use for the condition being studied.|
|Study medication or drug||This term may be used to describe the investigational medication or other study treatment (such as placebo) that a participant may receive while in the study.|
|Open-label, open-label extension||In an open-label study, or open-label extension (continuation of the study) both the study team and the participant know which treatment group they have been assigned to, or which study treatment is being administered.|
|Single-blind||In a single-blind study, the study participant does not know the study treatment group they have been assigned to, but the study team does.|
|Double-blind||In a double-blind study, neither the participant nor the study team knows which study treatment group the participant has been assigned to, but the study team can find out in case of an emergency.|
|Placebo||A substance that looks like the investigational medication but has no active medicinal ingredients. Placebos are used to compare the effectiveness of the investigational medication against no treatment. This is important to correct for the “placebo effect” when people feel better because they think they’re taking a medicine, even if the medicine does not do anything.|
|Protocol||A detailed plan describing the purpose of a study, how the study will be conducted, who can participate, the investigational medication that will be administered, and how the effects will be monitored.|
|Randomisation||Randomised clinical trials assign participants at random to groups or cohorts within the trial, with each group receiving a different study treatment regimen. The different regimens may include the investigational medication, a placebo, an alternative therapy, or some combination of them.
Randomisation is important in gathering clear, unbiased results. Not all studies involve placebos, alternative therapies, or randomisation. If a particular study is randomised, patients will be made aware before agreeing to participate.
|Study team, or study site team||The doctors, nurses, and other professionals who are conducting a study at a particular clinic or hospital. The doctors may also be referred to as investigators for the study.|