An observational study in IGA Nephropathy, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
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Among 18 studies in Glomerulonephritis, IGA by Novartis — 9 open to participants now, 12 under way, 7 of them phase 3. Glomerulonephritis, IGA · Novartis.
Among the 18 studies in Glomerulonephritis, IGA by Novartis, this one is one of 5 that started in 2026, is one of 3 observational ones, and was the 17th registered.
276 studies on the registry are indexed under Glomerulonephritis, IGA; 108 are open to participants now.
Browse Glomerulonephritis, IGA studies →9 of the 18 studies in Glomerulonephritis, IGA by Novartis are open now, in 12 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States, China, Colombia and 5 more countries
Ages 2–18
Novartis Pharmaceuticals · Sites in United States, Brazil, China and 8 more countries
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Argentina, Australia and 5 more countries
Ages 2–18
Novartis Pharmaceuticals · Sites in United States, Argentina, Australia and 6 more countries
Ages 18–100
Novartis Pharmaceuticals · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 68 Glomerulonephritis, IGA studies recruiting now, 39 (57%) set no upper age limit and 24 (35%) stop at 75 or younger; 21 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
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18 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 6 · Phase 3 8
First in 2018; this study’s year is marked. 5 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6,286 is above the median of 273 across 46 observational studies indexed under Glomerulonephritis, IGA.
Median enrollment 108 across the 14 interventional studies, 300 across the 3 observational. Of the 5 that completed or were terminated, 3 (60%) have results posted.
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This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
2 of the studies in Glomerulonephritis, IGA by Novartis that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05852938Phase 3Novartis PharmaceuticalsA Study of Zigakibart in Adults With IgA Nephropathy | 2027-08-10 |
| NCT06797518Novartis PharmaceuticalsStudy to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN | 2027-11-27 |
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Among the 18 studies in Glomerulonephritis, IGA by Novartis, from their registry updates:
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The aim of this study was to characterize real-world treatment patterns, including therapy sequences, escalation, and duration, and treatment outcomes in IgA nephropathy (IgAN) patients in the United States (US). The study used data which has detailed information on renal biopsy and laboratory data, linked with medical and pharmacy claims.
Adult patients with biopsy-confirmed IgAN in the US.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
IgAN Cohort:
Treatment Escalation Cohort:
Exclusion Criteria:
IgAN Cohort:
Treatment Escalation Cohort:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with biopsy-confirmed IgAN.
A subgroup of the IgAN Cohort. Patients treated with RAASi who progressed beyond supportive care (3-month course of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEi/ARB) therapy) and were candidates for additional therapy following insufficient disease management measured by elevated proteinuria.
Proportion of Patients Treated With any Therapy at any Time During the Study Period
Time frame: 365 days
Among Patients that Received Treatment, Proportion of Patients Who Received any of the Drug Classes of Interest at any Time During the Study Period
Drug classes of interest include: * RAASi * Corticosteroids/glucocorticoids/MMF * SGLT2i * Targeted release budesonide * Sparsentan * Atrasentan * Iptacopan * Sibeprenlimab
Time frame: 365 days
Among Patients that Received Treatment, Number of Fills of the Drugs in Drug Classes of Interest
Drug classes of interest include: * RAASi * Corticosteroids/glucocorticoids/MMF * SGLT2i * Targeted release budesonide * Sparsentan * Atrasentan * Iptacopan * Sibeprenlimab
Time frame: 365 days
Among Patients that Received Treatment, Duration of Treatment With Drugs in Drug Classes of Interest
Drug classes of interest include: * RAASi * Corticosteroids/glucocorticoids/MMF * SGLT2i * Targeted release budesonide * Sparsentan * Atrasentan * Iptacopan * Sibeprenlimab
Time frame: 365 days
Duration of Each Line of Therapy (LOT)
Time frame: 365 days
For Each LOT, Number of Fills of Each Drug Class
Time frame: 365 days
For Each LOT, Percentage of Patients that Discontinue First-line (1L), Second-line (2L), and Third-line (3L) of Therapy
Time frame: 365 days
Among Patients Who Discontinue 1L, 2L, 3L Therapy, Time to Treatment Discontinuation
Time frame: 365 days
Among Patients that Received Treatment, Proportion of Patients by Treatment Sequence
Treatment sequence refers to longitudinal sequence of LOTs received across the follow-up period. The date of treatment initiation and line end date was recorded to determine the number of patients by sequence of treatment. Line end date was defined as the date of the earliest of censoring or treatment discontinuation. Patients were censored at the earliest date of death, disenrollment, or end of the study period.
Time frame: 365 days
Proportion of Patients by Demographics, Clinical, and Laboratory Characteristics
Demographics, clinical, and laboratory characteristics include: * Age group * Sex * Race * Ethnicity * Insurance type * Charlson Comorbidity Index (CCI) group (0, 1, 2, 3+) * Comorbidities * Proteinuria category * Hematuria (yes/no) * Glomerular inflammation (yes/no)
Time frame: Baseline
Age at Index
Time frame: Baseline
Charlson Comorbidity Index (CCI) Score
CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be categorized as low (0-1) and high (≥2).
Time frame: Baseline
Proportion of Patients by Chronic Kidney Disease (CKD) Stage
CKD stages: * Stage 1: Normal or minimal kidney damage with normal GFR (eGFR ≥90 mL/min/1.73m²) * Stage 2: Mild decrease in GFR (eGFR 60-89 mL/min/1.73m²) * Stage 3a: Mild to moderate decrease in GFR (eGFR 45-59 mL/min/1.73m²) * Stage 3b: Moderate to severe decrease in GFR (eGFR 30-44 mL/min/1.73m²) * Stage 4: Severe decrease in GFR (eGFR 15-29 mL/min/1.73m²) * Stage 5: Kidney failure (eGFR \<15 mL/min/1.73m²)
Time frame: Baseline
eGFR
Time frame: Baseline
eGFR Slope
Time frame: Baseline
Proteinuria
Proteinuria assessed using UPCR.
Time frame: Baseline
Mesangial Hypercellularity, Endocapillary Hypercellularity, Segmental Glomerulosclerosis, Tubular Atrophy/Interstitial Fibrosis, Crescents (MEST-C) Score
MEST-C score is the histopathologic classification system used in IgAN kidney biopsies to describe key lesions associated with disease progression. It is part of the Oxford Classification and is recommended as part of IgAN assessment. It includes five components. All five components are scored by categorical values as listed below. A higher score indicates involvement or a relatively greater degree of involvement (i.e., more severe pathology). 1. Mesangial hypercellularity (M) * M0 (present in ≤50% of glomeruli) * M1 (present in \>50% of glomeruli) 2. Endocapillary hypercellularity (E) * E0 (Absent) * E1 (Present) 3. Segmental glomerulosclerosis (S) * S0 (Absent) * S1 (Present) 4. Tubular atrophy/interstitial fibrosis (T) * T0 (0-25% of cortical area) * T1 (26-50% of cortical area) * T2 (\>50% of cortical area) 5. Cellular crescents (C) * C0 (No crescents) * C1 (present in \<25% of glomeruli) * C2 (present in ≥25% of glomeruli)
Time frame: Baseline
Proportion of Patients Achieving Proteinuria <0.3 g/d
Time frame: 365 days
Proportion of Patients Achieving Proteinuria <0.5g/d
Time frame: 365 days
Proportion of Patients Treated With any Therapy at any Time During the Study Period, Categorized by Disease Management Goal Status
Disease management goal status is a binary variable, meaning patients achieved or did not achieve disease management.
Time frame: 365 days
Among Patients that Received Treatment, Proportion of Patients Who Received any of the Drug Classes of Interest at any Time During the Study Period, Categorized by Disease Management Goal Status
Time frame: 365 days
Among Patients that Received Treatment, Duration of Treatment With Drugs in Each Drug Class of Interest, Categorized by Disease Management Goal Status
Time frame: 365 days
Among Patients that Received Treatment, Number of LOTs Received, Categorized by Disease Management Goal Status
Time frame: 365 days
Among Patients that Received Treatment, Proportion of Patients by Most Common Treatment Sequences, Categorized by Disease Management Goal Status
Time frame: 365 days
Number of Steroid-related Adverse Events (AEs) per Patient per Year (PPPY)
Time frame: 365 days
Proportion of Patients with ≥1 Steroid-related AE
Time frame: 365 days
Proportion of Patients With ≥1 Steroid-related AE-related Outpatient, Inpatient, and Emergency Department Visit
Time frame: 365 days
Number of Steroid-related AE-related Outpatient, Inpatient, and Emergency Department Visits
Time frame: 365 days
Proportion of Patients With ≥1 ARB-related AE
Time frame: 365 days
Number of ARB-related AEs PPPY
Time frame: 365 days
Proportion of Patients With ≥1 ARB-related AE-related Outpatient, Inpatient, and Emergency Department Visit
Time frame: 365 days
Number of ARB-related AE-related Outpatient, Inpatient, and Emergency Department Visits
Time frame: 365 days
Among Patients Treated With RAASi Therapy Who had Elevated and Non-elevated Proteinuria, Proportion of Patients by Demographics and Clinical Characteristics
Demographics and clinical characteristics include: * Age group * Sex * Race * Ethnicity * Insurance type * Comorbidities
Time frame: Baseline
Among Patients Treated With RAASi Therapy Who had Elevated and Non-elevated Proteinuria, Age at Index
Time frame: Baseline
Among Patients Treated With RAASi Therapy Who had Elevated and Non-elevated Proteinuria, CCI Score
Time frame: Baseline
Proportion of Patients With Elevated Proteinuria Who Moved onto a Subsequent LOT Following the RAASi Containing LOT
Proportion of patients with treatment escalation.
Time frame: 182 days
Proportion of Patients Who Escalated to Another Drug, by Class of Drug
Drug classes include SGLT2is, immunosuppressants (corticosteroids and MMF), and IgAN branded therapy.
Time frame: 182 days
Proportion of Patients by Each Post-escalation Treatment Sequence
Time frame: 182 days
Time to Treatment Escalation for Patients With Elevated Proteinuria After Receiving Treatment With RAASi Therapy
Time frame: 182 days
Plan to share: No
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Ran from Mar 2026 to primary completion in Jul 2026, 3 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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