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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.

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 Drug: Pegcetacoplan Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 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
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : September 2022

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The number and incidence of treatment-related adverse events (AEs) [ Time Frame: 52 weeks after enrollment ]
  2. The proportion of patients with reduction in C3c staining on renal biopsy [ Time Frame: 52 weeks after enrollment ]
  3. The proportion of patients achieving at least a 50% reduction in proteinuria, over time [ Time Frame: 52 weeks after enrollment ]
  4. The proportion of patients achieving complete clinical remission of proteinuria, defined as normalization of proteinuria [ Time Frame: 52 weeks after enrollment ]
  5. The proportion of patients with stabilization or improvement in estimated glomerular filtration rate (eGFR), over time [ Time Frame: 52 weeks after enrollment ]


Information from the National Library of Medicine

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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:

  • 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

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


Contacts
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Contact: Apellis Clinical Trial Information Line +1 (617) 977-5700 clinicaltrials@apellis.com

Sponsors and Collaborators
Apellis Pharmaceuticals, Inc.
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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: October 1, 2020
Last Verified: September 2020

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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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Recurrence
Disease Attributes
Pathologic Processes