Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04572854
Recruitment Status : Not yet recruiting
First Posted : October 1, 2020
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE September 29, 2020
First Posted Date  ICMJE October 1, 2020
Last Update Posted Date October 1, 2020
Estimated Study Start Date  ICMJE November 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2020)
The primary efficacy endpoint is the proportion of patients with reduction in C3c staining on renal biopsy after 12 weeks of treatment with pegcetacoplan. [ Time Frame: 12 weeks after enrollemtn ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2020)
  • The number and incidence of treatment-related adverse events (AEs) [ Time Frame: 52 weeks after enrollment ]
  • The proportion of patients with reduction in C3c staining on renal biopsy [ Time Frame: 52 weeks after enrollment ]
  • The proportion of patients achieving at least a 50% reduction in proteinuria, over time [ Time Frame: 52 weeks after enrollment ]
  • The proportion of patients achieving complete clinical remission of proteinuria, defined as normalization of proteinuria [ Time Frame: 52 weeks after enrollment ]
  • The proportion of patients with stabilization or improvement in estimated glomerular filtration rate (eGFR), over time [ Time Frame: 52 weeks after enrollment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • C3G
  • IC-MPGN
  • Renal Transplant
Intervention  ICMJE Drug: Pegcetacoplan
Complement (C3) Inhibitor
Study Arms  ICMJE
  • Experimental: Group 1
    Pegcetacoplan treatment of 1080 mg (sub-cutaneous infusion) twice weekly will be given throughout the entire study.
    Intervention: Drug: Pegcetacoplan
  • Group 2
    No intervention given during the randomized controlled portion of the study (through week 12). After week 12, subjects will receive pegcetacoplan treatment.
    Intervention: Drug: Pegcetacoplan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2020)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients of at least 18 years of age at screening
  • Patients must have clinical and pathologic evidence of recurrent C3G or IC-MPGN, as evidenced by all of the following:
  • Stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months preceding the first dose of pegcetacoplan
  • eGFR ≥30 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
  • Willing to receive vaccinations against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae if applicable vaccination records are not available

Exclusion Criteria:

  • 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
  • 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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Apellis Clinical Trial Information Line +1 (617) 977-5700 clinicaltrials@apellis.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04572854
Other Study ID Numbers  ICMJE APL2-C3G-204
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Apellis Pharmaceuticals, Inc.
Study Sponsor  ICMJE Apellis Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Apellis Pharmaceuticals, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP