Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3G or IC-MPG: A Multi-Country Study
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSwedish Orphan Biovitrum
About this trial
The purpose of this study is to evaluate the effectiveness and safety of Pegcetacoplan in patients with C3G and primary IC-MPGN in the real-world setting. This study will also assess biomarkers not routinely measured in clinical practice. Results will support the long-term evaluation of the benefit-risk profile of pegcetacoplan in a broad patient population, informing clinical decision-making.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have received or plan to receive pegcetacoplan for the treatment of C3G or primary IC-MPGN.
Provided signed and dated informed consent. For participants under the legal age signed and dated informed consent is provided by the participant's legally authorised representative. Assent will also be obtained from paediatric participants as required by local regulations.
Disqualifiers
Receiving an investigational treatment for C3G or primary IC-MPGN at the time of pegcetacoplan initiation.
Initiated treatment with pegcetacoplan in an interventional study.
Trial design
Design model
Single group
Treatments tested in this trial
Pegcetacoplan
DrugSolution for infusion for subcutaneous use according to drug use in the real world.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Single armOther 1 intervention
Trial outcomes
Primary outcomes
1
Achieving urine protein-to-creatinine ratio (UPCR) of <1 g/g
To describe the real-world clinical effectiveness of pegcetacoplan in participants with C3G or primary IC-MPGN
Time frame
at 6 months after starting pegcetacoplan treatmentSecondary outcomes
1
Participant demographics (age, sex, race)
To describe the demographics of participants initiating pegcetacoplan treatment.
Time frame
Day 1 of treatment/Baseline.2
Clinical characteristics of renal disease (UPCR)
To describe clinical characteristics (UPCR), of renal disease in participants initiating pegcetacoplan treatment.
Time frame
Prior to and - Day 1 of treatment/Baseline.3
Clinical characteristics of renal disease (eGFR)
To describe clinical characteristics (eGFR), of renal disease in participants initiating pegcetacoplan treatment.
Time frame
Prior to and - Day 1 of treatment/Baseline.4
Prior and concomitant C3G and primary IC-MPGN treatment information
To describe the medication use of participants initiating pegcetacoplan treatment.
Time frame
Day 1 of treatment/Baseline.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Swedish Orphan Biovitrum
Lead sponsor
IQVIA Pty Ltd
Collaborator
Source ClinicalTrials.gov