Pegcetacoplan for Recurrent Kidney Disease
(NOBLE Trial)

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Apellis Pharmaceuticals, Inc.

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

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.

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.

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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

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Treatment Details

Interventions

Pegcetacoplan (Complement Inhibitor)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment1 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 1Experimental Treatment1 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: