Skip to main content
OpenTrials
Completed

NCT Number: NCT04572854

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

C3G C3 Glomerulonephritis C3 Glomerulopathy Complement 3 Glomerulonephritis Complement 3 Glomerulopathy Complement 3 Glomerulopathy (C3G) Dense Deposit Disease (DDD) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, Membranoproliferative IC-MPGN Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Immune System Diseases Kidney Diseases Male Urogenital Diseases Membranoproliferative Glomerulonephritis Membranoproliferative Glomerulonephritis (MPGN) Nephritis Renal Transplant Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital de Alta Complejidad en Red El Cruce Dr. Nestor Carlos Kirchner, San Juan Bautista, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pegcetacoplan

Drug

Complement (C3) Inhibitor

Primary outcomes

  1. Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 12

    Time frame: Baseline (Day 1) and Week 12

    C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Reduction in C3c staining was defined as decrease of at least 2 orders of magnitude of intensity from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.

Secondary outcomes

  1. Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 52

    Time frame: Baseline (Day 1) and Week 52

    C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Reduction in C3c staining was defined as decrease of at least 2 orders of magnitude of intensity from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.

  2. Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52

    Time frame: Baseline (Day 1), Week 12 and Week 52

    C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. Number of subjects who demonstrated a shift of C3c staining from baseline to Week 12 and baseline to Week 52 are presented.

  3. Percentage of Subjects With Stabilization or Improvement in Estimated Glomerular Filtration Rate (eGFR) at Week 52

    Time frame: Baseline (Day 1) and Week 52

    eGFR was calculated by using Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) creatinine equation. Stabilization or improvement in eGFR was defined as no more than a 25% decrease relative to baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.

  4. Percentage of Subjects With Stabilization or Improvement of Serum Creatinine Concentration at Week 52

    Time frame: Baseline (Day 1) and Week 52

    Stabilization or improvement in serum creatinine was defined as no increase or an increase of no more than 25% from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.

  5. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52

    Time frame: Baseline (Day 1) and Week 52

    Blood samples were collected at specified timepoints for analysis of eGFR which was calculated by using CKD-EPI creatinine equation. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.

  6. Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52

    Time frame: Baseline (Day 1) and Week 52

    Blood samples were collected at specified timepoints for analysis of eGFR which was calculated by using CKD-EPI creatinine equation. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.

  7. Change From Baseline in Serum Creatinine Concentration at Week 52

    Time frame: Baseline (Day 1) and Week 52

    Blood samples were collected at specified timepoints for analysis of serum creatinine concentration. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.

  8. Percentage Change From Baseline in Serum Creatinine Concentration at Week 52

    Time frame: Baseline (Day 1) and Week 52

    Blood samples were collected at specified timepoints for analysis of serum creatinine concentration. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.

Sponsors and collaborators

Lead sponsor

Apellis Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Acronym: NOBLE

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Oct 1, 2020
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.