Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN

Renal Transplant Clinical Trial

— NOBLE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04572854
• Other study ID #: APL2-C3G-204
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 23, 2021
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: Apellis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: January 2026
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age at screening

• Must have clinical and pathologic evidence of recurrent C3G or IC-MPGN

• 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 non-responders to vaccination.

Exclusion Criteria:

• Absolute neutrophil count <1000 cells/mm3 during screening

• 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:

• Cured basal or squamous cell skin cancer

• Curatively treated in situ disease

• 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

• 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

• Known or suspected hereditary fructose intolerance.

Related Conditions & MeSH terms

• C3 Glomerulonephritis
• C3 Glomerulopathy
• C3G
• Complement 3 Glomerulopathy
• Complement 3 Glomerulopathy (C3G)
• Glomerulonephritis
• Glomerulonephritis, Membranoproliferative
• IC-MPGN
• Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
• Membranoproliferative Glomerulonephritis
• Membranoproliferative Glomerulonephritis (MPGN)
• Recurrence
• Renal Transplant

Intervention

Drug:
• Pegcetacoplan
Complement (C3) Inhibitor

Locations

Country	Name	City	State
Argentina	Hospital Universitario Fundacion Favaloro	Buenos Aires
Argentina	Hospital de Alta Complejidad en Red El Cruce Dr. Nestor Carlos Kirchner	Florencio Varela	Provincia De Buenos Aires
Australia	Monash Medical Centre	Clayton
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Austria	Medical University of Vienna	Vienna
Brazil	Santa Casa de Misericordia de Belo Horizonte	Belo Horizonte
Brazil	UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP	Botucatu	Sao Paulo
Brazil	Irmandade da Santa Casa de Misericordia de Porto Alegre	Porto Alegre	RS
Brazil	Clinical Research Center, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo
France	Lille Regional University Hospital Center, Claude Huriez Hospital, Department of Nephrology	Lille
France	Hopital Edouard Herriot, Hospices Civils de Lyon	Lyon
France	Center Hospitalier Universitaire de Montpellier	Montpellier
Italy	Istituto di Ricerche Farmacologiche Mario Negri IRCCS	Ranica
Netherlands	Radbound University Medical Center	Nijmegen
Spain	Hospital Universitario 12 de Octubre, Nephrology Department	Madrid
Switzerland	CHUV	Lausanne
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Freeman Hospital	Newcastle Upon Tyne
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Keck School of Medicine, University of Southern California	Los Angeles	California
United States	CUIMC	New York	New York
United States	NYU Langone Health Transplant Insitute	New York	New York
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University, St.Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Apellis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  France,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is the proportion of subjects with reduction in C3c staining on renal biopsy after 12 weeks of treatment with pegcetacoplan.		12 weeks after randomization
Secondary	The proportion of subjects with reduction in C3c staining on renal biopsy		52 weeks after randomization
Secondary	The proportion of subjects with stabilization or improvement in estimated glomerular filtration rate (eGFR)		52 weeks after randomization
Secondary	The proportion of subjects with stabilization or improvement of serum creatinine concentration		52 weeks after randomization