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

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ClinicalTrials.gov Identifier: NCT04572854
Recruitment Status : Active, not recruiting
First Posted : October 1, 2020
Last Update Posted : March 6, 2024
Sponsor:
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
C3G IC-MPGN Renal Transplant Complement 3 Glomerulopathy Complement 3 Glomerulopathy (C3G) Dense Deposit Disease (DDD) Membranoproliferative Glomerulonephritis Membranoproliferative Glomerulonephritis (MPGN) Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) C3 Glomerulopathy C3 Glomerulonephritis Complement 3 Glomerulonephritis Drug: Pegcetacoplan Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 23, 2021
Actual Primary Completion Date : February 27, 2023
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
Pegcetacoplan treatment of 1080 mg (sub-cutaneous infusion) twice weekly will be given throughout the entire study.
 Drug: Pegcetacoplan
Complement (C3) Inhibitor
Group 2
No intervention given during the randomized controlled portion of the study (through week 12). After week 12, subjects will receive pegcetacoplan treatment.
 Drug: Pegcetacoplan
Complement (C3) Inhibitor


Outcome Measures
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Primary Outcome Measures :
  1. The primary efficacy endpoint is the proportion of subjects with reduction in C3c staining on renal biopsy after 12 weeks of treatment with pegcetacoplan. [ Time Frame: 12 weeks after randomization ]

Secondary Outcome Measures :
  1. The proportion of subjects with reduction in C3c staining on renal biopsy [ Time Frame: 52 weeks after randomization ]
  2. The proportion of subjects with stabilization or improvement in estimated glomerular filtration rate (eGFR) [ Time Frame: 52 weeks after randomization ]
  3. The proportion of subjects with stabilization or improvement of serum creatinine concentration [ Time Frame: 52 weeks after randomization ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572854


Locations
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Sponsors and Collaborators
Apellis Pharmaceuticals, Inc.
More Information
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Responsible Party: Apellis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04572854    
Other Study ID Numbers: APL2-C3G-204
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: March 6, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glomerulonephritis
Glomerulonephritis, Membranoproliferative
Recurrence
Disease Attributes
Pathologic Processes
Nephritis
Kidney Diseases
 Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Immune System Diseases