CHART-C3G/CLNP023B12011

C3 Glomerulopathy Patient Characteristics and Treatment Response to Iptacopan in Routine Care: Analysis of Medical Charts (CHART-C3G)

This is a non-interventional chart abstraction cohort study with longitudinal follow up. Patients with C3G treated with iptacopan will be enrolled and characterized (i.e., systematically describe and summarize) regarding their medical history and iptacopan use and evaluated for clinical events, outcomes, and laboratory measurements upon and after iptacopan treatment initiation. Medical charts will be used to obtain secondary pseudonymized patient-level data with reference to 2 time anchors: at index date (date of iptacopan treatment initiation) with baseline covering 12 months prior to index date, and at 12-month follow-up (twelve months after the index date).The observation period includes baseline plus follow-up.

Iptacopan will be used as prescribed by the clinician in accordance with the terms of the marketing authorization. This Novartis-sponsored study, mainly executed by a contract research organization (CRO), will use secondary data from EHR obtained through reference centers/ centers of excellence in glomerular diseases in Germany.

The primary objective of this study is to characterize the demographic and clinical profiles of adult patients diagnosed with C3G upon iptacopan treatment initiation.

Study Overview

• Status: Not yet recruiting
• Conditions: Proteinuria; C3 Glomerulopathy; Complement-mediated Kidney Disease
• Intervention / Treatment: Other: Iptacopan

Detailed Description

Until recently, there are no approved disease-specific treatments for C3G, although there is significant interest in the therapeutic potential of complement inhibition.

Iptacopan, the first oral effective targeted disease-modifying proximal complement inhibitor developed by Novartis, has been approved in April 2025 for the treatment of adults with C3G.

The primary objective of this study is to characterize the demographic and clinical profiles of adult patients diagnosed with C3G upon iptacopan treatment initiation.

By analyzing key endpoints such as age, sex, ethnicity, BMI, clinical symptoms, proteinuria, blood pressure, serum creatinine, eGFR, serum C3 levels, and renal histological parameters, we aim to better understand disease progression and treatment outcomes.

Additionally, we will assess CKD stages, history of kidney failure, dialysis status, transplant status, and comorbidities to identify the characteristics of patients treated with iptacopan.

• Study Type: Observational
• Enrollment (Estimated): 83

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients aged ≥18 years clinically diagnosed with C3G from participating study sites who initiate iptacopan during the period between 31-Mar-2025 and 31-Dec-2025

Description

Inclusion Criteria:

• Clinical diagnosis of C3G (confirmed by biopsy, only if available)
• Aged ≥18 years at time of index date.
• At least 6 months of baseline period preceding index date.
• Users of iptacopan treatment including those who have discontinued iptacopan within the last twelve weeks.

Exclusion Criteria:

• Interventional C3G clinical trial participation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Iptacopan; Adult patients with C3G initiating iptacopan treatment in routine care	Other: Iptacopan; There is no treatment allocation for NIS trials. Patients administered Iptacopan by prescription will be enrolled.; Other Names: LNP023B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics: Number of patients by age	Age at baseline in years	Baseline
Demographics: Number of patients by sex	Female Male	Baseline
Demographics: Number of patients by site	Academic hospital Other sites	Baseline
Demographics: Body mass index	Body mass index reported at baseline, or the closest value before baseline. In the absence of records for body mass index, it can be calculated using records of height and weight.	Baseline
Demographics: Number of patinets with Biopsy confirming C3G	No Yes	Baseline
Clinical symptoms: Proteinuria - Number of participants by 24-hour uPCR	No Yes 24-hour uPCR < 1 g/g 24-hour uPCR ≥ 1 g/g	Baseline
Proteinuria - Number of participants by spot uPCR	No Yes Spot uPCR < 1 g/g Spot uPCR ≥ 1 g/g	Baseline
Proteinuria, 24-hour uPCR in g/g	Absolute value of uPCR based on a 24-hour urine collection	Baseline
Proteinuria, spot uPCR in g/g	Absolute value of uPCR based on a spot urine collection	Baseline
Clinical symptoms: Albuminuria	No Yes	Baseline
Albuminuria - Number of participants by spot uACR	No Yes	Baseline
Albuminuria, 24-hour uACR in g/g	Absolute value of uACR based on a 24-hour urine collection	Baseline
Albuminuria, spot uACR in g/g	No Yes	Baseline
Clinical symptoms: Number of participants by Hematuria - dipstick results	No Yes Microscopic (≥3RBCs/HPF) Macroscopic (visible to the naked eye)	Baseline
Hematuria - Number of participants by urinalysis results	0-2 red blood cells ≥3 red blood cells	Baseline
Hematuria - urinalysis, number of red blood cells	Number of red blood cells detected through urinalysis	Baseline
Clinical symptoms: Number of participants with presence of edema	Presence of edema. No Yes	Baseline
Clinical symptoms: Systolic and diastolic blood pressure	Blood pressure measurement	Baseline
Clinical symptoms: Number of participants with hypertension	Defined as systolic blood pressure ≥140 mmHg or a diastolic blood pressure ≥90 mmHg No Yes	Baseline
Clinical symptoms: Serum creatinine at baseline	Absolute value of serum creatinine	Baseline
Clinical symptoms: Reported eGFR at baseline	Based on medical records of eGFR	Baseline
Clinical symptoms: Number of participants by equation used in reported eGFR at baseline	2021 CKD-EPI creatinine 2021 CKD-EPI creatinine-cystatin C 2012 CKD-EPI cystatin C 2012 CKD-EPI creatinine-cystatin C 2009 CKD-EPI creatinine MDRD (based on creatinine) Cockroft-Gault (based on creatinine) Schwartz equation (based on creatinine) Not specified	Baseline
Clinical symptoms: Computed eGFR at baseline	eGFR computed in the study analysis	Baseline
Clinical symptoms: Serum C3 at baseline	Reference range: LLN = 4.33-5.00 μmol/L ULN = 9.05-11.16 μmol/L	Baseline
Clinical events and outcomes: Time since C3G diagnosis (days/months)	Time since the first C3G diagnosis to baseline	Baseline
Clinical events and outcomes: Number of participants with Chronic Kidney Disease (CKD) and stage	No Yes Stage 1 Stage 2 Stage 3 Stage 4 Stage 5	Baseline
Clinical events and outcomes: Number of participants with history of kidney failure	No Yes (either of the categories below) eGFR ≤ 15 History of dialysis History of kidney transplant	Baseline
Clinical events and outcomes: Number of participants by dialysis status	No Yes Dialysis at diagnosis of C3G Maintenance dialysis Other types	Baseline
Clinical events and outcomes: Time from C3G diagnosis to dialysis (months)	Concerns only patients with dialysis at or before baseline	Baseline
Clinical events and outcomes: Time from dialysis to baseline (months)	Concerns only patients with dialysis at or before baseline	Baseline
Clinical events and outcomes: Number of participants by transplant status at baseline	No (native kidney) Yes Biopsy-confirmed disease in native kidney No evidence of disease recurrence Recurrent disease in transplanted kidney	Baseline
Clinical events and outcomes: Time from C3G diagnosis to kidney transplant before baseline (months)	Concerns only patients with a kidney transplant (or kidney transplant failure) at or before baseline	Baseline
Clinical events and outcomes: Time from kidney transplant before baseline to baseline (months)	Concerns only patients with a kidney transplant (or kidney transplant failure) at or before baseline	Baseline
Clinical events and outcomes: Number of participants with C3G disease recurrence post-transplant and/or transplant failure	Concerns only patients with a kidney transplant (or kidney transplant failure) at or before baseline. No Yes	Baseline
Clinical events and outcomes: Number of participants with comorbidities	For example, history of heart failure, history of stroke, diabetes mellitus, dementia, malignancy	Baseline
Renal histopathological parameters: Number of participants with presence of cysts	No Yes	Baseline
Renal histopathological parameters: Number of participants with presence of tumors	No Yes	Baseline
Renal histopathological parameters: Number of participants with presence of interstitial fibrosis or tubular atrophy	Mild Moderate Severe	Baseline
Renal histopathological parameters: Number of participants with presence of glomerulosclerosis	Mild Moderate Severe	Baseline
Renal histopathological parameters: Endocapillary hypercellularity	Presence of cells in capillary loops with loop occlusion 0 = 0% (Essentially normal or no lesion); = 1-25% (Only a small fraction of loops are occluded by hypercellularity); = 26-50% (About one-quarter to half of the loops show occlusion); = ≥51% (More than half of the loops are occluded, indicating extensive endocapillary proliferation)	Baseline
Renal histopathological parameters: Neutrophils in capillary lumens (each glomerulus is scored)	0 = 0% (No neutrophils in any capillary loops of the glomerulus); = 1-25% (Mild involvement: neutrophils present in up to ¼ of loops); = 26-50% (Moderate involvement: neutrophils in about ¼ to half of loops); = ≥51% (Severe involvement: neutrophils in more than half of loops)	Baseline
Renal histopathological parameters: Mesangial hypercellularity	More than 4 cells in a mesangial area away from the hilum 0 = 0% (No mesangial areas with >4 cells); = 1-25% (Mild involvement: 1-25% of mesangial areas show hypercellularity); = 26-50% (Moderate involvement: 26-50% of mesangial areas affected); = ≥51% (Severe involvement: More than half of mesangial areas show hypercellularity)	Baseline
Renal histopathological parameters: Necrosis	Necrosis in glomerular pathology refers to active destructive lesions characterized by: Disruption of the glomerular basement membrane (GBM) Fibrin exudation into Bowman's space or capillary loops Karyorrhexis (fragmentation of nuclei of inflammatory cells) - at least 2 of these 3 lesions need to be present to meet the criteria for necrosis. 0 = 0% (No glomeruli show necrosis); = 1-10% (Mild: 1-10% of glomeruli have necrosis); = 11-25% (Moderate: 11-25% of glomeruli affected); = ≥25% (Severe: More than 25% of glomeruli show necrosis)	Baseline
Renal histopathological parameters: Cellular or fibrocellular crescents	0 = 0% (No crescents in any glomeruli); = 1-10% (Mild: 1-10% of glomeruli have crescents); = 11-25% (Moderate: 11-25% of glomeruli affected); = >25% (Severe: More than 25% of glomeruli show crescents)	Baseline
Renal histopathological parameters: Activity index	A score between 0 and 15, calculated by summing up the scores from the activity index parameters above (Endocapillary hypercellularity,. Neutrophils in capillary lumens, Mesangial hypercellularity, Necrosis and Cellular or fibrocellular crescents). Score 0: No active lesions. The kidney shows chronic changes only, but no ongoing inflammation. Higher score implies not aggressively active, and kidney damage is likely stable or progressing slowly.	Baseline
Renal histopathological parameters: score inflammation assessment scale	Both continuous (score inflammation assessment scale) and categorically (none, mild, moderate, severe). Continuous Scale (Numeric Score); Low score (e.g., 0-3) Minimal inflammatory activity; High score (e.g., ≥9) Extensive active lesions (necrosis, crescents, heavy infiltration) Categorical Scale (None, Mild, Moderate, Severe); None: No significant inflammation; likely chronic or inactive disease.; Mild: Small, focal involvement; early or controlled disease.; Moderate: Widespread but not diffuse; active disease needing treatment.; Severe: Diffuse, aggressive inflammation; high risk of rapid progression to renal failure.	Baseline
Renal histopathological parameters: Number of participants by typo of inflammation	Type of inflammation: none, mild, moderate, severe	Baseline
Chronicity index parameters: Number of participants with glomerular (or segmental) sclerosis	0 = ≤10%; = 11-25%; = 26-50%; = ≥51%	Baseline
Chronicity index parameters: Number of participants with Fibrous crescents	0 = none; = ≤25%; = 26-50% 3= >51%	Baseline
Chronicity index parameters: Number of participants with tubular atrophy	0 = ≤5%; = 6-25%; = 26-50%; = ≥51%	Baseline
Chronicity index parameters: Number of participants with interstitial fibrosis	0 = ≤5%; = 6-25%; = 26-50%; = ≥51%	Baseline
Renal histopathological parameters: Chronicity index	A score between 0 and 12, calculated by summing up the scores from the chronicity index parameters above (Glomerular (or segmental) sclerosis, Fibrous crescents, Tubular atrophy and Interstitial fibrosis) Lower scores indicate less chronic damage, higher scores indicate more scarring and poor prognosis. 0-3 (Minimal to Mild) → Very little irreversible damage. Prognosis is generally favorable if activity index is also low. 4-6 (Moderate); Significant chronic changes; recovery potential is limited. 7-12 (Severe); Extensive scarring; immunosuppression unlikely to reverse damage	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical events and outcomes: Number of participants with kindney failure during follow-up	No Yes	Up to 12 months
Clinical events and outcomes: Time from C3G diagnosis to kidney failure and time from baseline to kidney failure	Concerns only patients with kidney failure during follow-up	Up to 12 months
Clinical events and outcomes: Number of participants with dialysis during follow-up	No Yes Maintenance dialysis Other types	Up to 12 months
Clinical events and outcomes:Time from kidney failure to first dialysis (months)	Concerns only patients with dialysis during follow-up	Up to 12 months
Clinical events and outcomes: Time from baseline to first dialysis (months)	Concerns only patients with dialysis during follow-up	Up to 12 months
Clinical events and outcomes: Time from kidney failure to maintenance dialysis (months)	Concerns only patients with maintenance dialysis during follow-up	Up to 12 months
Clinical events and outcomes: Time from C3G diagnosis to maintenance dialysis (months)	Concerns only patients with maintenance dialysis during follow-up	Up to 12 months
Clinical events and outcomes: Time from baseline to maintenance dialysis (months)	Concerns only patients with maintenance dialysis during follow-up	Up to 12 months
Clinical events and outcomes: Number of participants with complete remission (controlled) of C3G during follow-up	No Yes	Up to 12 months
Clinical events and outcomes: Number of participants with nephrotic-range and non-nephrotic range proteinuria during follow-up	Non-nephrotic-range proteinuria (0.15-3.5 g of protein in a 24-hour urine collection) Nephrotic-range proteinuria (> 3.5 g of protein in a 24- hour urine collection)	Up to 12 months
Clinical events and outcomes: Number of participants with renal relapse, progression to a higher CKD stage, or chronic renal replacement therapy during follow-up	No Yes Renal relapse Progression to a higher CKD stage Chronic renal replacement therapy	Up to 12 months
Clinical events and outcomes: Number of transplant failures per patient during follow-up	Transplant failure is defined as a follow-up record of either maintenance dialysis, sustained eGFR <15 mL/min/1.73m², or re-transplant	Up to 12 months
Clinical events and outcomes: Number of participants with CKD and stage at 12-month follow-up	No Yes Stage 1 Stage 2 Stage 3 Stage 4 Stage 5	Up to 12 months
Clinical events and outcomes: Number of participants by transplant status at 12-month follow-up	No (native kidney) Yes Biopsy-confirmed disease in native kidney No evidence of disease recurrence Recurrent disease in transplanted kidney	Up to 12 months
Clinical events and outcomes: Number of participants with Kidney transplant during follow-up	No Yes No transplant failure during follow-up Transplant failure during follow-up	Up to 12 months
Clinical events and outcomes: Time from kidney failure to transplant during follow-up (months)	Concerns only patients with a kidney transplant (or kidney transplant failure) during follow-up	Up to 12 months
Clinical events and outcomes: Time from transplant during follow-up to post- transplant C3G disease recurrence (months)	Concerns only patients with a kidney transplant (or kidney transplant failure) during follow-up and a post-transplant C3G disease recurrence during follow-up	Up to 12 months
Clinical events and outcomes: Time from transplant to transplant failure (months)	Concerns only patients with a kidney transplant during follow-up and a transplant failure during follow-up	Up to 12 months
Clinical events and outcomes: Number of participants with C3G disease recurrence post-transplant and/or transplant failure	Concerns only patients with a kidney transplant (or kidney transplant failure) during follow-up. No Yes C3G disease recurrence post-transplant Transplant failure C3G disease recurrence post-transplant and transplant failure	Up to 12 months
Clinical events and outcomes: Time from C3G disease recurrence to transplant failure	Concerns only patients with the combination of kidney transplant during follow-up, C3G disease recurrence post-transplant, and subsequent transplant failure	Up to 12 months
Clinical events and outcomes: Time from transplant at any time to post- transplant C3G disease recurrence	Concerns patients with a kidney transplant (or kidney failure) at any time, including baseline and follow-up, and post-transplant C3G disease recurrence at any time, including baseline and follow-up	Up to 12 months
Clinical events and outcomes: Number of participants with death during follow-up	No Yes	Up to 12 months
Clinical events and outcomes: Number of participants by cause of Death	Concerns only patients with death during follow-up. Kidney failure Infectious disease Cardiovascular disease Other causes	Up to 12 Months
Laboratory measurements: Serum creatinine or eGFR	Serum creatinine (preferred) or eGFR	6 months, 12 months and 24 months before baseline and up to 12 months follow-up
Laboratory measurements: eGFR slope during the 24months prior to baseline	Average eGFR slope computed using baseline computed eGFR and available historical serum creatinine values (preferred) or eGFR	24 months prior to baseline and 12 months post baseline
Laboratory measurements: Change in reported eGFR from baseline to 12-month follow-up, mL/min/1.73m	Difference in absolute value of reported eGFR between end of follow-up and baseline	Baseline, Month 12
Laboratory measurements: Equation used in reported 12-month follow-up eGFR	Equation used in reported 12-month follow-up eGFR: 2021 CKD-EPI creatinine 2021 CKD-EPI creatinine-cystatin C 2012 CKD-EPI cystatin C MDRD (based on creatinine) Cockroft-Gault (based on creatinine) Schwartz equation (based on creatinine) Not specified	Month 12 follow-up
Laboratory measurements: Follow-up serum creatinine or eGFR 6 months after baseline	Serum creatinine (preferred) or eGFR at 6 months after baseline	Up to 12 months
Laboratory measurements: eGFR slope during the 12 months after baseline, mL/min/1.73m²/year	Average eGFR slope computed using available follow-up serum creatinine values (preferred) or eGFR	Up to 12 months
Laboratory measurements: Change in computed eGFR from baseline to 12-month, mL/min/1.73m	Difference in absolute value of computed eGFR between end of follow-up and baseline	Baseline, Month 12
Laboratory measurements: Number of participants with Proteinuria 24-hour uPCR	No Yes 24-hour uPCR < 1 g/g 24-hour uPCR ≥ 1 g/g	Up to 12 months
Laboratory measurements: Number of participants with Proteinuria at 12-month follow-up - spot uPCR	No Yes Spot uPCR < 1 g/g Spot uPCR ≥ 1 g/g	Up to 12 months
Laboratory measurements: Proteinuria at 12-month, spot uPCR in g/g	Absolute value of uPCR based on a spot urine collection	Up to 12 months
Laboratory measurements: Proteinuria at 12-month follow-up, 24-hour uPCR in g/g	Absolute value of uPCR based on a 24-hour urine collection	Up to 12 months
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up, 24-hour uPCR in g/g	Difference in absolute value of 24-hour uPCR from baseline to 12-month follow-up, in g/g	Baseline, Month 12
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up, spot uPCR in g/g	Difference in absolute value of spot uPCR from baseline to 12-month follow-up, in g/g	Baseline, Month 12
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up in mg/mmol - 24-hour uPCR	Change of uPCR based on a 24-hour urine collection from baseline to 12-month follow-up, in mg/mmol Below 100 mg/mmol Above 100 mg/mmol	Baseline, Month 12
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up in mg/mmol - spot uPCR	Change of uPCR based on a spot urine collection from baseline to 12-month follow-up, in mg/mmol Below 100 mg/mmol Above 100 mg/mmol	Baseline, Month 12
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up in g/g - 24-hour uPCR	Change of uPCR based on a 24-hour urine collection from baseline to 12-month follow-up, in mg/mmol Below 1 g/g Above 1 g/g	Baseline, Month 12
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up in g/g - spot uPCR	Change of uPCR based on a spot urine collection from baseline to 12-month follow-up, in mg/mmol Below 1 g/g Above 1 g/g	Baseline, Month 12
Laboratory measurements: Number of participants with albuminuria	No Yes	Up to 12 months
Laboratory measurements: Number of participants with Albuminuria at 12-month follow-up - spot uACR	No Yes	Up to 12 months
Laboratory measurements: Albuminuria at 12-month follow-up, 24-hour uACR in g/g	Absolute value of uACR based on a 24-hour urine collection	Up to 12 months
Laboratory measurements: Albuminuria at 12-month follow-up, spot uACR in g/g	Absolute value of uACR based on a spot urine collection	Up to 12 months
Laboratory measurements: Change in albuminuria from baseline to 12-month follow-up, 24-hour uACR in g/g	Difference in absolute value of 24-hour uACR from baseline to 12-month follow-up	Baseline, Month 12
Laboratory measurements: Change in albuminuria from baseline to 12-month follow-up, spot uACR in g/g	Difference in absolute value of spot uACR from baseline to 12-month follow-up	Baseline, Month 12
Laboratory measurements: Number of participants with Hematuria dipstick	No Yes Microscopic Macroscopic	Up to 12 months
Laboratory measurements: Hematuria - Number of participants by urinalysis results	0-2 red blood cells ≥3 red blood cells	Up to 12 months
Laboratory measurements: Hematuria - urinalysis, number of red blood cells	Number of red blood cells detected through urinalysis	Up to 12 months
Laboratory measurements: Change in hematuria from baseline to 12-month follow-up	No change From no to yes From yes to no	Baseline, Month 12
Laboratory measurements: Change in hematuria on urinalysis from baseline to 12-month follow-up, number of red blood cells	Difference in absolute number of red blood cells detected through urinalysis from baseline to 12-month follow-up	Baseline, Month 12
Laboratory measurements: Number of participants with presence of autoantibodies	No Presence of any of the below autoantibodies C3NeF C4NeF C5NeF Anti-factor H autoantibodies Anti-factor B autoantibodies Anti-C3b autoantibodies	Up to month 12 follow-up
Laboratory measurements: CH50 and CH100	CH50: The 50% activity of the classic pathway of the complement CH100: Total activity of the classic pathway of the complement	Up to month 12 follow up
Laboratory measurements: AH50 and AH100	AH50: The 50% activity of the alternative pathway of the complement AH100: Total activity of the alternative pathway of the complement	Up to month 12 follow-up
Laboratory measurements: Wieslab activity of the alternative pathway of complement	Wieslab activity values are provided on a scale such that 100% of activity is normal activity. Full inhibition of alternative pathway corresponds to a value of 0	Up to month 12 follow-up
Laboratory measurements: Serum C3, Serum C4 and Serum C5	Serum C3 Reference range: LLN = 4.33-5.00 µmol/L ; ULN = 9.05-11.16 µmol/L Serum C4 Reference range: LLN = 0.50-0.70 µmol/L ; ULN = 2.00-2.60 µmol/L Serum C5 Reference range: LLN = 50 µg/mL ; ULN = 115 µg/mL	Up to month 12 follow-up
Laboratory measurements: Fibrinogen Degradation; (FD)	Reference range: LLN = 1437 µg/L ULN = 3966 µg/L	Up to month 12 follow-up
Laboratory measurements: fragment a of complement factor B (Ba)	Reference range: LLN = 338 ng/mL ULN = 1164 ng/mL	Up to month 12 follow-up
Laboratory measurements: fragment b of complement factor B (Bb)	Reference range: LLN = 0.49 mg/L ULN = 1.42 mg/L	Up to 12 months follow-up
Laboratory measurements: soluble terminal complement activation fragment (sC5b-9)	Reference range: LLN = 95 µg/L ULN = 467 µg/L	Up to 12 months follow-up
Disease management: Number of participants by status of vaccination and prophylactic antibiotic at baseline	Vaccination status at baseline Neisseria meningitidis Staphylococcus pneumoniae Vaccinated for both Received prophylactic antibiotic treatment	Up to 12 months follow up
Disease management: Number of participants by Iptacopan daily dose	Iptacopan daily dose at initiation and at the end of follow-up (or at discontinuation)	Baseline and up to 12 months follow-up
Disease management: Number of participants by Iptacopan daily dose change from baseline to the end of follow-up	Dose increase Dose decrease No modification	Baseline, up to month 12 follow-up
Disease management: Time to first modification of iptacopan dosage (days)	Time from baseline to the first modification of the daily dose of iptacopan	Up to 12 months-follow up
Disease management: Number of participants by reason of modification of iptacopan dosage during follow-up	Reason of modification of iptacopan dosage during follow-up	Up to 12 months follow-up
Disease management: Missed or delayed dose of iptacopan during follow-up	0 1-2 3-4 5 or more	Up to 12 months follow-up
Disease management: Number of participants with prior use of immunosuppressive medication	Immunosuppressive medication used before baseline and/or discontinued before baseline. No Yes Corticosteroids Prednisolone Methylprednisolone Cyclophosphamide Complement inhibitors C5 inhibitors (e.g., eculizumab) Other complement inhibitors (specify) Mycophenolate mofetil Rituximab Tacrolimus mTORi (everolimus/sirolimus) Other C3G medication (specify)	Up to month 12 follow-up
Disease management: Time from C3G diagnosis to the first complement inhibitor before baseline	Concerns only patients with prior use of complement inhibitors.	Baseline
Disease management: Number of participants by concomitant C3G treatments	Use of other C3G treatment in concomitance to iptacopan. No Yes ACEi/ARB Corticosteroids Prednisolone Methylprednisolone Cyclophosphamide Complement inhibitors C5 inhibitors (e.g., eculizumab) Other complement inhibitors (specify) Mycophenolate mofetil Rituximab SGLT2i Tacrolimus mTORi (everolimus/sirolimus) Other C3G medication (specify)	Up to 12 months follow-up
Disease management: Duration of C3G treatments during follow-up	Duration of each of the following C3G treatments during the follow-up: ACEi/ARB Corticosteroids Prednisolone Methylprednisolone Cyclophosphamide Complement inhibitors C5 inhibitors (e.g., eculizumab) Other complement inhibitors (specify) Mycophenolate mofetil Rituximab SGLT2i Tacrolimus mTORi (everolimus/sirolimus) Other C3G medication (specify)	Up to 12 months follow-up
Disease management: Number of participants by reason of discontinuation of C3G treatments during follow-up	treatments during the follow-up: ACEi/ARB Corticosteroids Prednisolone Methylprednisolone Cyclophosphamide Complement inhibitors C5 inhibitors (e.g., eculizumab) Other complement inhibitors (specify) Mycophenolate mofetil Rituximab SGLT2i Tacrolimus mTORi (everolimus/sirolimus) Other C3G medication (specify)	Up to 12 months follow-up
Disease management: Number of participants with antibiotic treatment related to C3G during follow- up	Any antibiotic therapy during follow-up No Yes	Up to 12 months follow-up
Disease management: Adherence to iptacopan treatment - PDC	PDC calculated as the total number of days between iptacopan initiation and treatment discontinuation or death. Patients are censored upon disenrollment or reaching the end of follow-up	Up to 12 months follow-up
Disease management: Number of participants by adherence to iptacopan treatment	PDC < 80% PDC ≥ 80%	Up to month 12 follow-up
Disease management: Number of participants with discontinuation of iptacopan during follow-up	Number of participants with discontinuation of iptacopan during follow-up and reason for discontinuation of iptacopan	Up to 12 months follow-up
Disease management: Time to iptacopan treatment discontinuation - TTD	Time from iptacopan initiation to iptacopan discontinuation or death. Patients are censored upon disenrollment or reaching the end of follow-up	Up to 12 months follow-up
Disease management: Number of participants with C3G treatment change after iptacopan discontinuation	Reason of discontinuation of each of the following C3G treatments during the follow-up: ACEi/ARB Corticosteroids Prednisolone Methylprednisolone Cyclophosphamide Complement inhibitors C5 inhibitors (e.g., eculizumab) Other complement inhibitors (specify) Mycophenolate mofetil Rituximab SGLT2i Tacrolimus mTORi (everolimus/sirolimus) Other C3G medication (specify)	Up to 12 months follow-up
Disease management: Numbre of participants by antibiotic treatment related to C3G during follow-up	Any antibiotic therapy during follow-up No Yes	Up to 12 months follow up
Disease management: Adherence to iptacopan treatment - PDC, %	PDC calculated as the total number of days between iptacopan initiation and treatment discontinuation or death. Patients are censored upon disenrollment or reaching the end of follow-up	Up to 12 months follow up
Disease management: Adherence to iptacopan treatment, n (%)	PDC < 80% PDC ≥ 80%	Up to 12 months follow up
Disease management: Number of participants discontinuing iptacopan during follow-up	Discontinuation of iptacopan, with no resumption during the follow-up period. No Yes	Up to 12 months follow up
Disease management: Number of participants by reason for discontinuation of iptacopan, n (%)	Concerning only patients with iptacopan discontinuation during follow-up. Infection Other adverse effects Death Loss to follow-up Other reasons (to be potentially defined during analysis)	Up to 12 months follow up
Disease management: Time to iptacopan treatment discontinuation - TTD, days	Time from iptacopan initiation to iptacopan discontinuation or death. Patients are censored upon disenrollment or reaching the end of follow-up	Up to 12 months follow up
Disease management: C3G treatment change after iptacopan discontinuation, n (%)	Concerning only patients with iptacopan discontinuation during follow-up. No Yes ACEi/ARB Corticosteroids Prednisolone Methylprednisolone Cyclophosphamide Complement inhibitors C5 inhibitors (e.g., eculizumab) Other complement inhibitors (specify) Mycophenolate mofetil Rituximab SGLT2i Tacrolimus mTORi (everolimus/sirolimus) Other C3G medication (specify)	Up to 12 months follow up
Healthcare resource utilization: Number of hospitalizations during the 12-month period before baseline	Number of hospitalizations, for any cause, during the 12- month period before baseline	Baseline
Healthcare resource utilization: Number of participants by cause of first hospitalization during the 12-month period before baseline	Concerns only patients with 1 or more hospitalizations during the 12-month period before baseline.	Baseline
Healthcare resource utilization: Length of first hospitalization during the 12-month period before baseline	Concerns only patients with 1 or more hospitalizations during the 12-month period before baseline	Baseline
Healthcare resource utilization: Number of participants bu cause of first readmission after first hospitalization during the 12-month period before baseline	Concerning only patients with 2 or more hospitalizations during the 12-month period before baseline	Baseline
Healthcare resource utilization: Length of first readmission after first hospitalization during the 12-month period before baseline	Concerns only patients with 2 or more hospitalizations during the 12-month period before baseline	Baseline
Healthcare resource utilization: Number of hospitalizations due to infection during the 12-month period before baseline	Number of hospitalizations due to infection during the 12-month period before baseline by Type (incl. pathogen) of infections	Baseline
Healthcare resource utilization: Number of hospitalizations during follow-up	Number of hospitalizations, for any cause, from baseline to 12-month follow-up	Up to 12 months follow-up
Healthcare resource utilization: Number of participants by cause of first hospitalization during follow-up	Concerns only patients with 1 or more hospitalizations during the follow-up period. Categories to be defined at the analysis stage.	Up to 12 months follow-up
Healthcare resource utilization: Length of first hospitalization during follow-up	Concerns only patients with 1 or more hospitalizations during the follow-up period	Up to 12 months follow-up
Healthcare resource utilization: Number of participants by cause of first readmission after first hospitalization during follow-up	Concerning only patients with 2 or more hospitalizations during the follow-up period. Categories to be defined at the analysis stage.	Up to 12 months follow-up
Healthcare resource utilization: Length of first readmission after first hospitalization during follow-up	Concerning only patients with 2 or more hospitalizations during the follow-up period	Up to 12 months follow-up
Healthcare resource utilization: Number of hospitalizations due to infection during follow-up	Number of hospitalizations due to infection during follow-up and Type (incl. pathogen) of infections	Up to 12 months follow-up

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Germany; Iptacopan; C3G; NIS-PDC; estimated Glomerular Filtration Rate
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Proteinuria; iptacopan
• Other Study ID Numbers: CLNP023B12011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO