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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iptacopan Cohort | Adult patients with C3G who received iptacopan through an EAP in Spain. |
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| Measure | Description | Time Frame |
|---|---|---|
| Baseline Demographics | Baseline | |
| Height | Baseline | |
| Weight | Baseline | |
| Blood Pressure | Systolic and diastolic blood pressure. | Baseline |
| Number and Percentage of Patients by Clinical Characteristic | Clinical characteristics include:
| Baseline |
| Duration of Antibiotic Prophylaxis | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 | |
| Number of Hospitalizations due to Severe Infection Before Iptacopan Initiation | Baseline | |
| Age at C3G Diagnosis | Baseline | |
| Number and Percentage of Patients by Clinical Features at First C3G Diagnosis | Clinical features include:
|
| Measure | Description | Time Frame |
|---|---|---|
| UPCR FMV During Iptacopan Treatment | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 | |
| UPCR-24h During Iptacopan Treatment | UPCR from 24-hour collection. | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
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Inclusion criteria:
Exclusion criteria:
1. Patients treated with iptacopan through an EAP for indications other than C3G.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D015432 | Glomerulonephritis, Membranoproliferative |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Baseline |
| Age at Last Kidney Transplantation Before Iptacopan Initiation | Baseline |
| Number of Kidney Transplants Before Iptacopan Initiation | Baseline |
| Number and Percentage of Patients by Clinical Features of Last Kidney Transplant Before Iptacopan Initiation | Clinical features include:
| Baseline |
| Duration of Cold Ischemia for the Last Kidney Transplant Before Iptacopan Initiation | Baseline |
| Post-Kidney Transplant Estimated Glomerular Filtration Rate (eGFR) | Baseline |
| Number and Percentage of Patients by Type of Biopsy Performed to Confirm Recurrence of C3G After Kidney Transplant | Baseline |
| Duration Between Last Kidney Transplant and Biopsy Confirmed C3G Recurrence | Baseline |
| eGFR at Last Post-transplant C3G Recurrence | Baseline |
| Serum Albumin Concentration at Last Post-transplant C3G Recurrence | Baseline |
| Urine Protein-Creatine Ratio (UPCR) From First-Morning Void (FMV) at Last Post-transplant C3G Recurrence | Baseline |
| Proteinuria-24h at Last Post-transplant C3G Recurrence | Total protein excretion from 24-hour collection. | Baseline |
| Serum Complement Component 3 (C3) Concentration at Last Post-transplant C3G Recurrence | Baseline |
| Proteinuria-24h During Iptacopan Treatment | Total protein excretion from 24-hour collection. | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Urine Albumin-to-Creatinine Ratio (UACR) FMV During Iptacopan Treatment | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| UACR-24h During Iptacopan Treatment | UACR from 24-hour collection. | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Albuminuria-24h During Iptacopan Treatment | Total albumin excretion from 24-hour collection. | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Serum Albumin Concentration During Iptacopan Treatment | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Serum Creatinine Concentration During Iptacopan Treatment | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| eGFR During Iptacopan Treatment | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Difference Between Post- and Pre-Iptacopan Treatment eGFR Slopes | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Number and Percentage of Patients With Kidney Failure | Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Number and Percentage of Patients With a Kidney Transplant During Follow-up | Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Number and Percentage of Patients Who Initiate Dialysis During Follow-up | Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Red Blood Cells (RBC) Count per High Power Field (HPF) During Iptacopan Treatment | 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:
| 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 | 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 | 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 | 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:
| 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 | 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:
| 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 | 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 | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Serum C3 Concentration During Iptacopan Treatment | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Serum Complement Component 4 (C4) Concentration During Iptacopan Treatment | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Serum Soluble Membrane Attach Complex (sC5b-9) Concentration During Iptacopan Treatment | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Total Complement Function Assay (CH50) Concentration During Iptacopan Treatment | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Daily Iptacopan Dose During Iptacopan Treatment | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Number of Missed or Delayed Doses During Iptacopan Treatment | Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Number and Percentage of Patients With Missed or Delayed Doses During Iptacopan Treatment | Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Number and Percentage of Patients Who Discontinued Iptacopan Treatment | Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Number and Percentage of Patients by Reason for Iptacopan Treatment Discontinuation | Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Time to Iptacopan Treatment Discontinuation | Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Number and Percentage of Patients by Type of Concomitant Therapies | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Treatment Dose of Concomitant Treatment | 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 | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Number and Percentage of Patients by Reason for Stopping Concomitant Treatment | 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. | 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. | 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. | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Length of Stay in Hospital | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Number and Percentage of Patients who Die During Iptacopan Treatment | Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007154 | Immune System Diseases |