Pegcetacoplan for Recurrent Kidney Disease

(NOBLE Trial)

Recruiting at 24 trial locations

Overseen By Apellis Clinical Trial Information Line

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Apellis Pharmaceuticals, Inc.

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

13 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called pegcetacoplan in patients who have had their kidney disease come back after a transplant. The medication aims to reduce inflammation and prevent further kidney damage by blocking certain immune system activities. The study will evaluate how safe and effective this treatment is for these patients.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, it mentions that your treatment for recurrent C3G/IC-MPGN should be stable for at least 4 weeks before the screening and until randomization.

Is Pegcetacoplan safe for human use?

Pegcetacoplan has been approved for use in treating paroxysmal nocturnal hemoglobinuria (PNH) in adults, indicating it has undergone safety evaluations. It is also being studied for other conditions, suggesting ongoing assessments of its safety profile. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults who've had a kidney transplant and are now facing a recurrence of certain kidney diseases (C3G or IC-MPGN). Participants should have stable or worsening disease, adequate kidney function, no significant other renal diseases, and must be vaccinated against specific infections. They can't join if they have certain infections like HIV or hepatitis, previous pegcetacoplan treatment, low neutrophil count, weigh over 100 kg, or have certain cancer histories.

Inclusion Criteria

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 non-responders to vaccination.

Exclusion Criteria

You have a kidney disease caused by another condition, like an infection or cancer, that would make it difficult to understand the study results.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomized Controlled Phase

Participants are randomized to receive either pegcetacoplan treatment or no intervention for 12 weeks

12 weeks

Bi-weekly visits for treatment group

Open-label Treatment Phase

All participants receive pegcetacoplan treatment after the initial 12 weeks

40 weeks

Bi-weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Pegcetacoplan

Trial Overview The study tests the safety and effectiveness of Pegcetacoplan in patients with post-transplant recurrence of C3G/IC-MPGN. It's an open-label Phase 2 trial where everyone knows what treatment is being given; some will receive Pegcetacoplan while others may not as part of the control group.

Participant Groups

Group I: Group 2 Experimental Treatment 1 Intervention

No intervention given during the randomized controlled portion of the study (through week 12). After week 12, subjects will receive pegcetacoplan treatment.

Group II: Group 1 Experimental Treatment 1 Intervention

Pegcetacoplan treatment of 1080 mg (sub-cutaneous infusion) twice weekly will be given throughout the entire study.

Pegcetacoplan is already approved in United States, European Union for the following indications:

Approved in United States as Empaveli for:

• Paroxysmal Nocturnal Hemoglobinuria (PNH)

Approved in European Union as Aspaveli for:

• Paroxysmal Nocturnal Hemoglobinuria (PNH)

Who Is Running the Clinical Trial?

Apellis Pharmaceuticals, Inc.

Lead Sponsor

Trials

26

Recruited

4,300+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Peginterferon alpha-2a (40 KD) plus ribavirin for the treatment of chronic hepatitis C in Japanese patients. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Polyethylene glycol conjugated interleukin-2: clinical and immunologic effects in patients with advanced renal cell carcinoma. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Phase II, randomized, multicenter, comparative study of peginterferon-alpha-2a (40 kD) (Pegasys) versus interferon alpha-2a (Roferon-A) in patients with treatment-naïve, chronic-phase chronic myelogenous leukemia. [2019]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Pegcetacoplan: First Approval. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Kidney tubular toxicity of maintenance pemetrexed therapy. [2022]