IGA NephropathyNCT07757048
A Study of Treatment Patterns and Real-World Outcomes in IgA Nephropathy Patients in the United States
An observational study of IGA Nephropathy, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- IGA Nephropathy
- How many people
- 6,286 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2026to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with biopsy-confirmed IgAN in the US.
Who may be able to join
- IgAN Cohort:
- Renal biopsy confirming IgAN during the patient identification period.
- Age ≥18 at index. The index date was the date of first claim or biopsy.
- ≥182 days of continuous enrollment in medical and pharmacy claims before index date.
- ≥365 days of continuous enrollment in medical and pharmacy claims following (and including) index date.
- Treatment Escalation Cohort:
Show all 12Show fewer
- Renal biopsy confirming IgAN during the patient identification period.
- Age ≥18 at index.
- ≥182 days of continuous enrollment in medical and pharmacy claims before index date.
- ≥182 days of continuous enrollment in medical and pharmacy claims following (and including) index date.
- Evidence of treatment with a renin-angiotensin-aldosterone system inhibitor (RAASi) for > 3 months following IgAN diagnosis date.
- ≥1 urine protein creatinine ratio (UPCR) lab measurement following the index date.
Who cannot join
- IgAN Cohort:
- Presence of systemic lupus erythematosus (SLE), lupus nephritis (LN), IgA vasculitis (IgAV), chronic liver disease, and Minimal Change Disease (MCD) with IgA deposition at any time during the study period.
- Treatment Escalation Cohort:
- Presence of SLE, LN, IgAV, chronic liver disease, and MCD with IgA deposition at any time during the study period.
- Any evidence of kidney failure as defined by estimated glomerular filtration rate (eGFR) <15 ml/min/1.73 m², International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes for chronic kidney disease (CKD) stage 5, Current Procedural Terminology (CPT) codes for kidney transplant or dialysis prior to RAASi initiation.
- Received any corticosteroids/mycophenolate mofetil (MMF), sodium-glucose co-transporter 2 inhibitor (SGLT2i), or IgAN branded therapies prior to the end of the 90 days of RAASi treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Current Treatment Patterns and Real-World Outcomes of Patients With IgA Nephropathy in the United States
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.
- Conditions
- IGA Nephropathy
- Keywords
- IgA Nephropathy
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IgAN Cohort | Adult patients with biopsy-confirmed IgAN. | |
| Treatment Escalation Cohort | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Treated With any Therapy at any Time During the Study Period
Measured: 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
Measured: 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
Measured: 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
Measured: 365 days
Duration of Each Line of Therapy (LOT)
Measured: 365 days
For Each LOT, Number of Fills of Each Drug Class
Measured: 365 days
For Each LOT, Percentage of Patients that Discontinue First-line (1L), Second-line (2L), and Third-line (3L) of Therapy
Measured: 365 days
Among Patients Who Discontinue 1L, 2L, 3L Therapy, Time to Treatment Discontinuation
Measured: 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.
Measured: 365 days
Secondary outcomes (30)
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)
Measured: Baseline
Age at Index
Measured: 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).
Measured: 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)
Measured: Baseline
eGFR
Measured: Baseline
eGFR Slope
Measured: Baseline
Proteinuria
Proteinuria assessed using UPCR.
Measured: 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).
- Mesangial hypercellularity (M)
- M0 (present in ≤50% of glomeruli)
- M1 (present in >50% of glomeruli)
- Endocapillary hypercellularity (E)
- E0 (Absent)
- E1 (Present)
- Segmental glomerulosclerosis (S)
- S0 (Absent)
- S1 (Present)
- Tubular atrophy/interstitial fibrosis (T)
- T0 (0-25% of cortical area)
- T1 (26-50% of cortical area)
- T2 (>50% of cortical area)
- Cellular crescents (C)
- C0 (No crescents)
- C1 (present in <25% of glomeruli)
- C2 (present in ≥25% of glomeruli)
Measured: Baseline
Proportion of Patients Achieving Proteinuria <0.3 g/d
Measured: 365 days
Proportion of Patients Achieving Proteinuria <0.5g/d
Measured: 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.
Measured: 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
Measured: 365 days
Among Patients that Received Treatment, Duration of Treatment With Drugs in Each Drug Class of Interest, Categorized by Disease Management Goal Status
Measured: 365 days
Among Patients that Received Treatment, Number of LOTs Received, Categorized by Disease Management Goal Status
Measured: 365 days
Among Patients that Received Treatment, Proportion of Patients by Most Common Treatment Sequences, Categorized by Disease Management Goal Status
Measured: 365 days
Number of Steroid-related Adverse Events (AEs) per Patient per Year (PPPY)
Measured: 365 days
Proportion of Patients with ≥1 Steroid-related AE
Measured: 365 days
Proportion of Patients With ≥1 Steroid-related AE-related Outpatient, Inpatient, and Emergency Department Visit
Measured: 365 days
Number of Steroid-related AE-related Outpatient, Inpatient, and Emergency Department Visits
Measured: 365 days
Proportion of Patients With ≥1 ARB-related AE
Measured: 365 days
Number of ARB-related AEs PPPY
Measured: 365 days
Proportion of Patients With ≥1 ARB-related AE-related Outpatient, Inpatient, and Emergency Department Visit
Measured: 365 days
Number of ARB-related AE-related Outpatient, Inpatient, and Emergency Department Visits
Measured: 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
Measured: Baseline
Among Patients Treated With RAASi Therapy Who had Elevated and Non-elevated Proteinuria, Age at Index
Measured: Baseline
Among Patients Treated With RAASi Therapy Who had Elevated and Non-elevated Proteinuria, CCI Score
Measured: Baseline
Proportion of Patients With Elevated Proteinuria Who Moved onto a Subsequent LOT Following the RAASi Containing LOT
Proportion of patients with treatment escalation.
Measured: 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.
Measured: 182 days
Proportion of Patients by Each Post-escalation Treatment Sequence
Measured: 182 days
Time to Treatment Escalation for Patients With Elevated Proteinuria After Receiving Treatment With RAASi Therapy
Measured: 182 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start12 Mar 2026
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IGA NephropathyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757048
- Sponsor's protocol ID
- CLNP023AUS11
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Treatment Patterns and Real-World Outcomes of Patients With IgA Nephropathy in the United States
- ClinicalTrials.gov ID
- NCT07757048
- Acronym / sponsor ID
- CLNP023AUS11
- Conditions
- IGA Nephropathy
- Keywords
- IgA Nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,286 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IgAN Cohort | – | –Adult patients with biopsy-confirmed IgAN. |
| Treatment Escalation Cohort | – | –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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with biopsy-confirmed IgAN in the US.
Key inclusion criteria (12 listed)
- Renal biopsy confirming IgAN during the patient identification period.
- Age ≥18 at index. The index date was the date of first claim or biopsy.
- ≥182 days of continuous enrollment in medical and pharmacy claims before index date.
- ≥365 days of continuous enrollment in medical and pharmacy claims following (and including) index date.
- Renal biopsy confirming IgAN during the patient identification period.
Key exclusion criteria (6 listed)
- Presence of systemic lupus erythematosus (SLE), lupus nephritis (LN), IgA vasculitis (IgAV), chronic liver disease, and Minimal Change Disease (MCD) with IgA deposition at any time during the study period.
- Presence of SLE, LN, IgAV, chronic liver disease, and MCD with IgA deposition at any time during the study period.
- Any evidence of kidney failure as defined by estimated glomerular filtration rate (eGFR) <15 ml/min/1.73 m², International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes for chronic kidney disease (CKD) stage 5, Current Procedural Terminology (CPT) codes for kidney transplant or dialysis prior to RAASi initiation.
- Received any corticosteroids/mycophenolate mofetil (MMF), sodium-glucose co-transporter 2 inhibitor (SGLT2i), or IgAN branded therapies prior to the end of the 90 days of RAASi treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 365 days
Drug classes of interest include: * RAASi * Corticosteroids/glucocorticoids/MMF * SGLT2i * Targeted release budesonide * Sparsentan * Atrasentan * Iptacopan * Sibeprenlimab
Among Patients that Received Treatment, Number of Fills of the Drugs in Drug Classes of Interest
Time frame: 365 days
Drug classes of interest include: * RAASi * Corticosteroids/glucocorticoids/MMF * SGLT2i * Targeted release budesonide * Sparsentan * Atrasentan * Iptacopan * Sibeprenlimab
Among Patients that Received Treatment, Duration of Treatment With Drugs in Drug Classes of Interest
Time frame: 365 days
Drug classes of interest include: * RAASi * Corticosteroids/glucocorticoids/MMF * SGLT2i * Targeted release budesonide * Sparsentan * Atrasentan * Iptacopan * Sibeprenlimab
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
Time frame: 365 days
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.
30 secondary outcomes
Proportion of Patients by Demographics, Clinical, and Laboratory Characteristics
Time frame: Baseline
Age at Index
Time frame: Baseline
Charlson Comorbidity Index (CCI) Score
Time frame: Baseline
Proportion of Patients by Chronic Kidney Disease (CKD) Stage
Time frame: Baseline
eGFR
Time frame: Baseline
eGFR Slope
Time frame: Baseline
Proteinuria
Time frame: Baseline
Mesangial Hypercellularity, Endocapillary Hypercellularity, Segmental Glomerulosclerosis, Tubular Atrophy/Interstitial Fibrosis, Crescents (MEST-C) Score
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
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
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
Time frame: 182 days
Proportion of Patients Who Escalated to Another Drug, by Class of Drug
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IGA Nephropathy, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Treated With any Therapy at any Time During the Study Period (time frame: 365 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.