CHART-C3G/CLNP023B12011

NCT07331259 | Not Yet Recruiting

• 1 other identifier: CLNP023B12011
• Study Type: observational
• Target: 83
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Complement-mediated Kidney Disease; C3 Glomerulopathy; Proteinuria

Keywords

NIS-PDC; Germany; C3G; Iptacopan; estimated Glomerular Filtration Rate

Outcome Measures

Primary Outcomes (52)

• 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. = 1-25% (Only a small fraction of loops are occluded by hypercellularity) 2. = 26-50% (About one-quarter to half of the loops show occlusion) 3. = ≥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. = 1-25% (Mild involvement: neutrophils present in up to ¼ of loops) 2. = 26-50% (Moderate involvement: neutrophils in about ¼ to half of loops) 3. = ≥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. = 1-25% (Mild involvement: 1-25% of mesangial areas show hypercellularity) 2. = 26-50% (Moderate involvement: 26-50% of mesangial areas affected) 3. = ≥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. = 1-10% (Mild: 1-10% of glomeruli have necrosis) 2. = 11-25% (Moderate: 11-25% of glomeruli affected) 3. = ≥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. = 1-10% (Mild: 1-10% of glomeruli have crescents) 2. = 11-25% (Moderate: 11-25% of glomeruli affected) 3. = \>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) 1. Low score (e.g., 0-3) Minimal inflammatory activity 2. High score (e.g., ≥9) Extensive active lesions (necrosis, crescents, heavy infiltration) Categorical Scale (None, Mild, Moderate, Severe) 1. None: No significant inflammation; likely chronic or inactive disease. 2. Mild: Small, focal involvement; early or controlled disease. 3. Moderate: Widespread but not diffuse; active disease needing treatment. 4. 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% 1. = 11-25% 2. = 26-50% 3. = ≥51%

  Baseline

• Chronicity index parameters: Number of participants with Fibrous crescents

  0 = none 1. = ≤25% 2. = 26-50% 3= \>51%

  Baseline

• Chronicity index parameters: Number of participants with tubular atrophy

  0 = ≤5% 1. = 6-25% 2. = 26-50% 3. = ≥51%

  Baseline

• Chronicity index parameters: Number of participants with interstitial fibrosis

  0 = ≤5% 1. = 6-25% 2. = 26-50% 3. = ≥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 Outcomes (96)

• Clinical events and outcomes: Number of participants with kindney failure during follow-up

  Up to 12 months

• Clinical events and outcomes: Time from C3G diagnosis to kidney failure and time from baseline to kidney failure

  Up to 12 months

• Clinical events and outcomes: Number of participants with dialysis during follow-up

  Up to 12 months

• Clinical events and outcomes:Time from kidney failure to first dialysis (months)

  Up to 12 months

• Clinical events and outcomes: Time from baseline to first dialysis (months)

  Up to 12 months

Study Arms (1)

Iptacopan

Adult patients with C3G initiating iptacopan treatment in routine care

Other: Iptacopan

Interventions

Iptacopan OTHER

There is no treatment allocation for NIS trials. Patients administered Iptacopan by prescription will be enrolled.

Also known as: LNP023B

Iptacopan

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Interventional C3G clinical trial participation

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Proteinuria

Interventions

iptacopan

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share