An observational study in Complement 3 Glomerulopathy, sponsored by Novartis Pharmaceuticals. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Novartis Pharmaceuticals · Observational
This study aims to characterize the patient profiles and the clinical experience of iptacopan treatment in adult patients with C3G treated through an early access program (EAP) in Spain.
Adult patients with a diagnosis of C3G who have received at least one dose of iptacopan through an EAP from 01 October 2020 through 30 June 2025.
Exclusion criteria:
1. Patients treated with iptacopan through an EAP for indications other than C3G.
Adult patients with C3G who received iptacopan through an EAP in Spain.
Baseline Demographics
Time frame: Baseline
Height
Time frame: Baseline
Weight
Time frame: Baseline
Blood Pressure
Systolic and diastolic blood pressure.
Time frame: Baseline
Number and Percentage of Patients by Clinical Characteristic
Clinical characteristics include: * Kidney status * History of dialysis * Presence of edema * Comorbidities * C3G histology subtype * Previous medication * Vaccination status * Receipt of antibiotic prophylaxis in addition to vaccination * History of severe infections
Time frame: Baseline
Duration of Antibiotic Prophylaxis
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number of Hospitalizations due to Severe Infection Before Iptacopan Initiation
Time frame: Baseline
Age at C3G Diagnosis
Time frame: Baseline
Number and Percentage of Patients by Clinical Features at First C3G Diagnosis
Clinical features include: * Clinical presentation (nephrotic, nephritic, isolated non-nephrotic proteinuria, asymptomatic urinary abnormalities) * Presence of pathogenic variants in complement-related genes * Presence of autoantibodies against complement components
Time frame: Baseline
Age at Last Kidney Transplantation Before Iptacopan Initiation
Time frame: Baseline
Number of Kidney Transplants Before Iptacopan Initiation
Time frame: Baseline
Number and Percentage of Patients by Clinical Features of Last Kidney Transplant Before Iptacopan Initiation
Clinical features include: * Previous recurrence with kidney failure * Kidney donor type * Highly sensitized (yes/no) * Immediate graft function * Type of induction therapy * Type of maintenance immunosuppressive (IS) therapy * Kidney transplant rejection episode and type of rejection
Time frame: Baseline
Duration of Cold Ischemia for the Last Kidney Transplant Before Iptacopan Initiation
Time frame: Baseline
Post-Kidney Transplant Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline
Number and Percentage of Patients by Type of Biopsy Performed to Confirm Recurrence of C3G After Kidney Transplant
Time frame: Baseline
Duration Between Last Kidney Transplant and Biopsy Confirmed C3G Recurrence
Time frame: Baseline
eGFR at Last Post-transplant C3G Recurrence
Time frame: Baseline
Serum Albumin Concentration at Last Post-transplant C3G Recurrence
Time frame: Baseline
Urine Protein-Creatine Ratio (UPCR) From First-Morning Void (FMV) at Last Post-transplant C3G Recurrence
Time frame: Baseline
Proteinuria-24h at Last Post-transplant C3G Recurrence
Total protein excretion from 24-hour collection.
Time frame: Baseline
Serum Complement Component 3 (C3) Concentration at Last Post-transplant C3G Recurrence
Time frame: Baseline
UPCR FMV During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
UPCR-24h During Iptacopan Treatment
UPCR from 24-hour collection.
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Proteinuria-24h During Iptacopan Treatment
Total protein excretion from 24-hour collection.
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Urine Albumin-to-Creatinine Ratio (UACR) FMV During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
UACR-24h During Iptacopan Treatment
UACR from 24-hour collection.
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Albuminuria-24h During Iptacopan Treatment
Total albumin excretion from 24-hour collection.
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Serum Albumin Concentration During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Serum Creatinine Concentration During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
eGFR During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Difference Between Post- and Pre-Iptacopan Treatment eGFR Slopes
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients With Kidney Failure
Time frame: Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients With a Kidney Transplant During Follow-up
Time frame: Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients Who Initiate Dialysis During Follow-up
Time frame: Months 3, 6, 9, 12, 18, 24, 30, and 36
Red Blood Cells (RBC) Count per High Power Field (HPF) During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Intensity of C3 Deposit in Direct Immunofluorescence (DIF) During Iptacopan Treatment
DIF intensity: * 0 (negative) * +1 (mild) * +2 (moderate) * +3 (strong)
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Type of Antibody Used for DIF at Each Biopsy During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Presence of Globally Sclerotic Glomeruli and Glomeruli With Crescents at Each Biopsy During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Percentage of Globally Sclerotic Glomeruli and Glomeruli With Crescents at Each Biopsy During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Degree of Interstitial Fibrosis/Tubular Atrophy (IF/TA) at Each Biopsy During Iptacopan Treatment
Degree of IF/TA categories: * None * Mild (\<25%) * Moderate (25-50%) * Severe (\>50%)
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Presence of Arteriosclerosis or Arteriolosclerosis at Each Biopsy During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Light Microscopy Pattern at Each Biopsy During Iptacopan Treatment
Light microscopy patterns: * Membranoproliferative glomerulonephritis (MPGN) * Diffuse endocapillary glomerulonephritis (GN) * Mesangial proliferative GN * Diffuse sclerosing GN
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Presence of Double Contours at Each Biopsy During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Presence of Leukocyte Infiltration at Each Biopsy During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Serum C3 Concentration During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Serum Complement Component 4 (C4) Concentration During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Serum Soluble Membrane Attach Complex (sC5b-9) Concentration During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Total Complement Function Assay (CH50) Concentration During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Daily Iptacopan Dose During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number of Missed or Delayed Doses During Iptacopan Treatment
Time frame: Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients With Missed or Delayed Doses During Iptacopan Treatment
Time frame: Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients Who Discontinued Iptacopan Treatment
Time frame: Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Reason for Iptacopan Treatment Discontinuation
Time frame: Months 3, 6, 9, 12, 18, 24, 30, and 36
Time to Iptacopan Treatment Discontinuation
Time frame: Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Type of Concomitant Therapies
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Treatment Dose of Concomitant Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients on the Maximum Tolerated Dose of Concomitant Treatment: Renin-angiotensin System (RAS) Blockade
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Reason for Stopping Concomitant Treatment
Time frame: Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients With Adverse Events of Special Interest (AESI)
AESIs include infections by encapsulated bacteria, thyroid abnormality, testicular abnormality, hypersensitivity reaction, malignancy, and thrombocytopenia.
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients With Severe AESI
AESI include infections by encapsulated bacteria, thyroid abnormality, testicular abnormality, hypersensitivity reaction, malignancy, and thrombocytopenia. Infections are categorized as severe if present with any of the following: fever with shivers/chills; headache with fever; fever with rash; fever with chest pain and cough; fever with breathlessness/fast breathing; fever with high heart rate; headache with nausea/vomiting; headache with stiff neck/back; confusion; body aches with flu-like symptoms; clammy skin; eyes sensitive to light.
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients Hospitalized due to an AESI
AESIs include infections by encapsulated bacteria, thyroid abnormality, testicular abnormality, hypersensitivity reaction, malignancy, and thrombocytopenia.
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Length of Stay in Hospital
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients who Die During Iptacopan Treatment
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Plan to share: No
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Glomerulonephritis, Membranoproliferative→
Novartis Pharmaceuticals