Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04572854




Registration number
NCT04572854
Ethics application status
Date submitted
29/09/2020
Date registered
1/10/2020
Date last updated
6/03/2024

Titles & IDs
Public title
Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN
Scientific 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
Secondary ID [1] 0 0
APL2-C3G-204
Universal Trial Number (UTN)
Trial acronym
NOBLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
C3G 0 0
IC-MPGN 0 0
Renal Transplant 0 0
Complement 3 Glomerulopathy 0 0
Complement 3 Glomerulopathy (C3G) 0 0
Dense Deposit Disease (DDD) 0 0
Membranoproliferative Glomerulonephritis 0 0
Membranoproliferative Glomerulonephritis (MPGN) 0 0
Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) 0 0
C3 Glomerulopathy 0 0
C3 Glomerulonephritis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
No intervention: Standard of care - Control participants will be randomised to received standard of care treatment.
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Apellis Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04572854
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04572854