This is a 36-month, long-term, multicenter, observational study designed to describe the real world effectiveness of pegcetacoplan in patients with PNH. Patients meeting the eligibility criteria will be enrolled in the study and followed prospectively for approximately 36 months. Patient data will be collected from start of pegcetacoplan treatment to end of follow-up. Retrospective data on pegcetacoplan will be captured from the time of pegcetacoplan treatment initiation. Pegcetacoplan treatment data will be collected for a minimum of approximately 36 months and up to a maximum of approximately 72 months, including retrospective period depending on when the patient started pegcetacoplan treatment. After pegcetacoplan treatment discontinuation, patients will remain in the study for 8 weeks to capture any AEs. The scope of the study is to collect both retrospective and prospective data. Baseline is defined as start of pegcetacoplan treatment. The main part of the study will be prospective,collecting data on effectiveness, safety (all AEs), patient- and clinician-reported outcomes and health care resource use.
As pegcetacoplan is a new product on the market, with a new mechanism of action, there is an urgent need to provide data to treaters, payers and the PNH community on the real-world usage and effectiveness of pegcetacoplan. This study aims to fill part of that knowledge gap and to add to the knowledge base regarding the use of pegcetacoplan in routine medical practice. Another important rationale for this study is to provide information on RBC transfusions and health care resource utilization pre and post pegcetacoplan treatment initiation. The study plans to include approximately 200 patients at 70 sites in Europe, Middle East, Canada and Australia. Additional countries may be added in the study if necessary. Patients meeting the eligibility criteria will be enrolled in the study and followed prospectively for approximately 36 months. Patient data will be collected from start of pegcetacoplan treatment to end of follow-up. Retrospective data on pegcetacoplan will be captured from the time of pegcetacoplan treatment initiation. Pegcetacoplan treatment data will be collected for a minimum of approximately 36 months and up to a maximum of approximately 72 months, including retrospective period depending on when the patient started pegcetacoplan treatment. After pegcetacoplan treatment discontinuation, patients will remain in the study for 8 weeks to capture any AEs. Patients will come to their routine visits and the available data from each visit will be collected. The scope of the study is to collect both retrospective and prospective data. The main part of the study will be prospective, collecting data on effectiveness, safety, patient- and clinician-reported outcomes and health care resource use. The study will also collect retrospective data before pegcetacoplan treatment start, which will consist of information on PNH treatment, blood transfusions and healthcare resource use. Data will be collected for up to 12 months prior to pegcetacoplan treatment start. As patients may have been treated with pegcetacoplan for up to 12 months prior to enrollment, retrospective data may be collected for up to 24 months. This means that the total data collection period including both the retrospective and the prospective part is up to 48 (+/- 3) months.
Study Type
OBSERVATIONAL
Enrollment
165
Pegcetacoplan will be prescribed according to the label in patients with PNH.
Liverpool Hospital
Liverpool, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Canberra Hospital
Garran, Australia
Institut Jules Bordet
Anderlecht, Belgium
AZ Sint-Jan
Change in observed hemoglobin level from initiation of treatment with pegcetacoplan to 6 months
Hemoglobin level in g/dL.
Time frame: 6 months
Change of LDH values from initiation of pegcetacoplan treatment to 6 months
Lactate Dehydrogenase (LDH) in U/L
Time frame: 6 months
Change in Absolute Reticulocyte Count (ARC) from initiation of pegcetacoplan treatment to 6 months
Absolute Reticulocyte Count (ARC) in 10\^9/L
Time frame: 6 months
Change in indirect/ total bilirubin from initiation of pegcetacoplan treatment to 6 months
Indirect/ total bilirubin in umol/L
Time frame: 6 months
Change in Haptoglobin from initiation of pegcetacoplan treatment to 6 months
Haptoglobin in mg/dL
Time frame: 6 months
Change in Ferritin from initiation of pegcetacoplan treatment to 6 months
Ferritin in ug/L
Time frame: 6 months
Hemoglobin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 6 months
Hemoglobin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 12 months
Hemoglobin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 18 months
Hemoglobin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 24 months
Hemoglobin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 30 months
Hemoglobin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 36 months
Lactate Dehydrogenase at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Lactate Dehydrogenase (LDH) in U/L
Time frame: 6 months
Lactate Dehydrogenase at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Lactate Dehydrogenase (LDH) in U/L
Time frame: 12 months
Lactate Dehydrogenase at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Lactate Dehydrogenase (LDH) in U/L
Time frame: 18 months
Lactate Dehydrogenase at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Lactate Dehydrogenase (LDH) in U/L
Time frame: 24 months
Lactate Dehydrogenase at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Lactate Dehydrogenase (LDH) in U/L
Time frame: 30 months
Lactate Dehydrogenase at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Lactate Dehydrogenase (LDH) in U/L
Time frame: 36 months
Absolute Reticulocyte Count at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Absolute Reticulocyte Count (ARC) in 10\^9/L
Time frame: 6 months
Absolute Reticulocyte Count at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Absolute Reticulocyte Count (ARC) in 10\^9/L
Time frame: 12 months
Absolute Reticulocyte Count at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Absolute Reticulocyte Count (ARC) in 10\^9/L
Time frame: 18 months
Absolute Reticulocyte Count at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Absolute Reticulocyte Count (ARC) in 10\^9/L
Time frame: 24 months
Absolute Reticulocyte Count at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Absolute Reticulocyte Count (ARC) in 10\^9/L
Time frame: 30 months
Absolute Reticulocyte Count at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Absolute Reticulocyte Count (ARC) in 10\^9/L
Time frame: 36 months
Indirect/ total bilirubin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Indirect/ total bilirubin in umol/L
Time frame: 6 months
Indirect/ total bilirubin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Indirect/ total bilirubin in umol/L
Time frame: 12 months
Indirect/ total bilirubin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Indirect/ total bilirubin in umol/L
Time frame: 18 months
Indirect/ total bilirubin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Indirect/ total bilirubin in umol/L
Time frame: 24 months
Indirect/ total bilirubin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Indirect/ total bilirubin in umol/L
Time frame: 30 months
Indirect/ total bilirubin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Indirect/ total bilirubin in umol/L
Time frame: 36 months
Haptoglobin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Haptoglobin in µmol/L
Time frame: 6 months
Haptoglobin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Haptoglobin in µmol/L
Time frame: 12 months
Haptoglobin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Haptoglobin in µmol/L
Time frame: 18 months
Haptoglobin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Haptoglobin in µmol/L
Time frame: 24 months
Haptoglobin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Haptoglobin in µmol/L
Time frame: 30 months
Haptoglobin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Haptoglobin in mg/dL
Time frame: 36 months
Ferritin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Ferritin in ug/L
Time frame: 6 months
Ferritin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Ferritin in ug/L
Time frame: 12 months
Ferritin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Ferritin in ug/L
Time frame: 18 months
Ferritin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Ferritin in ug/L
Time frame: 24 months
Ferritin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Ferritin in ug/L
Time frame: 30 months
Ferritin at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Ferritin in ug/L
Time frame: 36 months
Hemoglobin ≥ 12 g/dL at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 6 months
Hemoglobin ≥ 12 g/dL at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 12 months
Hemoglobin ≥ 12 g/dL at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 18 months
Hemoglobin ≥ 12 g/dL at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 24 months
Hemoglobin ≥ 12 g/dL at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 30 months
Hemoglobin ≥ 12 g/dL at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 36 months
Increase in hemoglobin levels of ≥ 2 g/dL at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 6 months
Increase in hemoglobin levels of ≥ 2 g/dL at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 12 months
Increase in hemoglobin levels of ≥ 2 g/dL at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 18 months
Increase in hemoglobin levels of ≥ 2 g/dL at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 24 months
Increase in hemoglobin levels of ≥ 2 g/dL at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 30 months
Increase in hemoglobin levels of ≥ 2 g/dL at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Hemoglobin in g/dL
Time frame: 36 months
Hemolytic event requiring additional intervention at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Yes/No
Time frame: 6 months
Hemolytic event requiring additional intervention at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Yes/No
Time frame: 12 months
Hemolytic event requiring additional intervention at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Yes/No
Time frame: 18 months
Hemolytic event requiring additional intervention at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Yes/No
Time frame: 24 months
Hemolytic event requiring additional intervention at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Yes/No
Time frame: 30 months
Hemolytic event requiring additional intervention at initiation of pegcetacoplan treatment and each 6 months until end of follow-up
Yes/No
Time frame: 36 months
Annualized number of red blood cell (RBC) transfusions during pegcetacoplan treatment until end of follow-up compared to the 12 month period before pegcetacoplan treatment
Total number of RBC transfusions
Time frame: 12 months
Annualized number of red blood cell (RBC) units during pegcetacoplan treatment until end of follow-up compared to the 12 month period before pegcetacoplan treatment
Total number of RBC units
Time frame: 12 months
Fatigue at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Patient reported outcome scale scores for the Functional assessment of chronic illness therapy (FACIT) - Fatigue. It is a 13-item scale and each item is scored on a 5-point Likert Scale ranging from "0-Not at all" to "4-Very much". The FACIT-fatigue score is obtained by summing all item scores. The score range from 0 to 52, higher score indicating less fatigue and lower score indicating more fatigue.
Time frame: 6 months
Fatigue at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Patient reported outcome scale scores for the Functional assessment of chronic illness therapy (FACIT) - Fatigue. It is a 13-item scale and each item is scored on a 5-point Likert Scale ranging from "0-Not at all" to "4-Very much". The FACIT-fatigue score is obtained by summing all item scores. The score range from 0 to 52, higher score indicating less fatigue and lower score indicating more fatigue.
Time frame: 12 months
Fatigue at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Patient reported outcome scale scores for the Functional assessment of chronic illness therapy (FACIT) - Fatigue. It is a 13-item scale and each item is scored on a 5-point Likert Scale ranging from "0-Not at all" to "4-Very much". The FACIT-fatigue score is obtained by summing all item scores. The score range from 0 to 52, higher score indicating less fatigue and lower score indicating more fatigue.
Time frame: 18 months
Fatigue at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Patient reported outcome scale scores for the Functional assessment of chronic illness therapy (FACIT) - Fatigue. It is a 13-item scale and each item is scored on a 5-point Likert Scale ranging from "0-Not at all" to "4-Very much". The FACIT-fatigue score is obtained by summing all item scores. The score range from 0 to 52, higher score indicating less fatigue and lower score indicating more fatigue.
Time frame: 24 months
Fatigue at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Patient reported outcome scale scores for the Functional assessment of chronic illness therapy (FACIT) - Fatigue. It is a 13-item scale and each item is scored on a 5-point Likert Scale ranging from "0-Not at all" to "4-Very much". The FACIT-fatigue score is obtained by summing all item scores. The score range from 0 to 52, higher score indicating less fatigue and lower score indicating more fatigue.
Time frame: 30 months
Fatigue at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Patient reported outcome scale scores for the Functional assessment of chronic illness therapy (FACIT) - Fatigue. It is a 13-item scale and each item is scored on a 5-point Likert Scale ranging from "0-Not at all" to "4-Very much". The FACIT-fatigue score is obtained by summing all item scores. The score range from 0 to 52, higher score indicating less fatigue and lower score indicating more fatigue.
Time frame: 36 months
Health care resource use: Annualized number of hospitalizations and emergency room visits during pegcetacoplan treatment until end of follow-up compared to the 12-month period before pegcetacoplan treatment.
Number of hospitalizations and emergency room visits
Time frame: 12 months
Patient treatment satisfaction every 6 months until end of follow-up
Patient treatment satisfaction (1-5 point scale), 5=highly satisfied, 1= highly dissatisfied
Time frame: 6 months
Patient treatment satisfaction every 6 months until end of follow-up
Patient treatment satisfaction (1-5 point scale), 5=highly satisfied, 1= highly dissatisfied
Time frame: 12 months
Patient treatment satisfaction every 6 months until end of follow-up
Patient treatment satisfaction (1-5 point scale), 5=highly satisfied, 1= highly dissatisfied
Time frame: 18 months
Patient treatment satisfaction every 6 months until end of follow-up
Patient treatment satisfaction (1-5 point scale), 5=highly satisfied, 1= highly dissatisfied
Time frame: 24 months
Patient treatment satisfaction every 6 months until end of follow-up
Patient treatment satisfaction (1-5 point scale), 5=highly satisfied, 1= highly dissatisfied
Time frame: 30 months
Patient treatment satisfaction every 6 months until end of follow-up
Patient treatment satisfaction (1-5 point scale), 5=highly satisfied, 1= highly dissatisfied
Time frame: 36 months
Physician treatment satisfaction every 6 months until end of follow-up
Physician treatment satisfaction (1-5 point scale), 5=highly satisfied, 1= highly dissatisfied
Time frame: 6 months
Physician treatment satisfaction every 6 months until end of follow-up
Physician treatment satisfaction (1-5 point scale), 5=highly satisfied, 1= highly dissatisfied
Time frame: 12 months
Physician treatment satisfaction every 6 months until end of follow-up
Physician treatment satisfaction (1-5 point scale), 5=highly satisfied, 1= highly dissatisfied
Time frame: 18 months
Physician treatment satisfaction every 6 months until end of follow-up
Physician treatment satisfaction (1-5 point scale), 5=highly satisfied, 1= highly dissatisfied
Time frame: 24 months
Physician treatment satisfaction every 6 months until end of follow-up
Physician treatment satisfaction (1-5 point scale), 5=highly satisfied, 1= highly dissatisfied
Time frame: 30 months
Physician treatment satisfaction every 6 months until end of follow-up
Physician treatment satisfaction (1-5 point scale), 5=highly satisfied, 1= highly dissatisfied
Time frame: 36 months
Adverse events (AE), including serious adverse events (SAE)
Adverse events (AE) and serious adverse events (SAE) are to be reported on the AE page of the eCRF as specified in the eCRF data entry guidelines.
Time frame: 24 hours
Alanine transaminase (ALT) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Alanine transaminase (ALT) in U/L
Time frame: 6 months
Alanine transaminase (ALT) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Alanine transaminase (ALT) in U/L
Time frame: 12 months
Alanine transaminase (ALT) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Alanine transaminase (ALT) in U/L
Time frame: 18 months
Alanine transaminase (ALT) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Alanine transaminase (ALT) in U/L
Time frame: 24 months
Alanine transaminase (ALT) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Alanine transaminase (ALT) in U/L
Time frame: 30 months
Alanine transaminase (ALT) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Alanine transaminase (ALT) in U/L
Time frame: 36 months
Aspartate aminotransferase (AST) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Aspartate aminotransferase (AST) in U/L
Time frame: 6 months
Aspartate aminotransferase (AST) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Aspartate aminotransferase (AST) in U/L
Time frame: 12 months
Aspartate aminotransferase (AST) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Aspartate aminotransferase (AST) in U/L
Time frame: 18 months
Aspartate aminotransferase (AST) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Aspartate aminotransferase (AST) in U/L
Time frame: 24 months
Aspartate aminotransferase (AST) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Aspartate aminotransferase (AST) in U/L
Time frame: 30 months
Aspartate aminotransferase (AST) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Aspartate aminotransferase (AST) in U/L
Time frame: 36 months
Alkaline Phosphatase at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Alkaline Phosphatase in µkat/L
Time frame: 6 months
Alkaline Phosphatase at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Alkaline Phosphatase in µkat/L
Time frame: 12 months
Alkaline Phosphatase at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Alkaline Phosphatase in µkat/L
Time frame: 18 months
Alkaline Phosphatase at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Alkaline Phosphatase in µkat/L
Time frame: 24 months
Alkaline Phosphatase at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Alkaline Phosphatase in µkat/L
Time frame: 30 months
Alkaline Phosphatase at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Alkaline Phosphatase in µkat/L
Time frame: 36 months
Bilirubin at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Indirect/ total bilirubin in umol/L
Time frame: 6 months
Bilirubin at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Indirect/ total bilirubin in umol/L
Time frame: 12 months
Bilirubin at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Indirect/ total bilirubin in umol/L
Time frame: 18 months
Bilirubin at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Indirect/ total bilirubin in umol/L
Time frame: 24 months
Bilirubin at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Indirect/ total bilirubin in umol/L
Time frame: 30 months
Bilirubin at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Indirect/ total bilirubin in umol/L
Time frame: 36 months
Creatinine at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Creatinine in mg/dL
Time frame: 6 months
Creatinine at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Creatinine in mg/dL
Time frame: 12 months
Creatinine at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Creatinine in mg/dL
Time frame: 18 months
Creatinine at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Creatinine in mg/dL
Time frame: 24 months
Creatinine at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Creatinine in mg/dL
Time frame: 30 months
Creatinine at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Creatinine in mg/dL
Time frame: 36 months
estimated glomerular filtration rate (eGFR) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
estimated glomerular filtration rate (eGFR) in mL/min/1.73 m²
Time frame: 6 months
estimated glomerular filtration rate (eGFR) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
estimated glomerular filtration rate (eGFR) in mL/min/1.73 m²
Time frame: 12 months
estimated glomerular filtration rate (eGFR) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
estimated glomerular filtration rate (eGFR) in mL/min/1.73 m²
Time frame: 18 months
estimated glomerular filtration rate (eGFR) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
estimated glomerular filtration rate (eGFR) in mL/min/1.73 m²
Time frame: 24 months
estimated glomerular filtration rate (eGFR) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
estimated glomerular filtration rate (eGFR) in mL/min/1.73 m²
Time frame: 30 months
estimated glomerular filtration rate (eGFR) at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
estimated glomerular filtration rate (eGFR) in mL/min/1.73 m²
Time frame: 36 months
Urea at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Urea in mg/dL
Time frame: 6 months
Urea at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Urea in mg/dL
Time frame: 12 months
Urea at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Urea in mg/dL
Time frame: 18 months
Urea at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Urea in mg/dL
Time frame: 24 months
Urea at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Urea in mg/dL
Time frame: 30 months
Urea at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Urea in mg/dL
Time frame: 36 months
Potassium at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Potassium in mmol/L
Time frame: 6 months
Potassium at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Potassium in mmol/L
Time frame: 12 months
Potassium at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Potassium in mmol/L
Time frame: 18 months
Potassium at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Potassium in mmol/L
Time frame: 24 months
Potassium at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Potassium in mmol/L
Time frame: 30 months
Potassium at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Potassium in mmol/L
Time frame: 36 months
Sodium at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Sodium in mmol/L
Time frame: 6 months
Sodium at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Sodium in mmol/L
Time frame: 12 months
Sodium at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Sodium in mmol/L
Time frame: 18 months
Sodium at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Sodium in mmol/L
Time frame: 24 months
Sodium at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Sodium in mmol/L
Time frame: 30 months
Sodium at initiation of treatment with pegcetacoplan and every 6 months until end of follow-up
Sodium in mmol/L
Time frame: 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Brussels, Belgium
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Liège, Belgium
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