Skuteczność i bezpieczeństwo pegcetacoplanu u pacjentów z C3 glomerulopatią lub pierwotnym immunokompleksowym zapaleniem nerek (IC‑MPGN) – badanie rzeczywiste

Enrollment and baseline Assessment

After joining the study you sign the consent form and provide basic information such as age, sex and race.

A series of baseline examinations are performed, including measurement of urine protein to creatinine ratio (UPCR), estimated glomerular filtration rate (egfr), other laboratory tests and, if required, a kidney biopsy to evaluate the disease.

Initiation of medication

You receive the first dose of aspaveli 1080 mg solution for infusion, which contains the active substance pegcetacoplan.

The dose is 308.6 mg administered by subcutaneous injection, following the schedule defined by the study protocol.

The medication is continued for the duration of the study according to the same dose and route.

First month follow‑up

Approximately four weeks after the first dose you attend a study visit.

Clinical evaluation, urine and blood tests (including UPCR and egfr) are repeated.

Questionnaires assessing fatigue and work productivity are completed.

Three month follow‑up

At three months a similar visit is performed.

The same set of laboratory tests and questionnaires are collected to monitor changes.

Six month primary endpoint visit

At six months the primary efficacy outcome is evaluated: achievement of UPCR lower than 1 g/g.

Comprehensive clinical Assessment, laboratory tests and safety monitoring are carried out.

Any serious adverse events, such as severe infections, malignancies or acute kidney injury, are recorded.

Twelve month follow‑up

At twelve months you undergo another study visit with the same clinical, laboratory and Questionnaire assessments.

The data are compared with earlier visits to assess long‑term response.

Ongoing six‑month interval visits

After the first year you continue to attend visits every six months.

Each visit includes measurement of UPCR, egfr, other laboratory parameters, and completion of patient‑reported outcome questionnaires.

Any changes in medication dose, temporary discontinuation or switch to another complement inhibitor are documented.

Annual evaluations

Once a year a more extensive evaluation may be performed, including repeat kidney biopsy if clinically indicated and detailed Assessment of biomarkers.

The annual data help to evaluate trends in kidney function and disease activity.

Monitoring for safety throughout the study

Throughout the entire study period you are instructed to report any new symptoms or health problems.

The study team records the incidence of serious adverse events (sae) and adverse events of special interest (aesi), such as severe infections, cancers and acute kidney injury.

Study completion and final data collection

At the end of the follow‑up period (up to june 2032) a final visit is performed.

All remaining clinical, laboratory and Questionnaire data are collected.

The study is closed for you after the final assessments are completed.