Immunoglobulin A NephropathyNCT06952426
A Mobile App-Based Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US
An observational study of Immunoglobulin A Nephropathy, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall health-related quality of life (HRQoL) experienced by Immunoglobulin A nephropathy (IgAN) patients and their caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunoglobulin A Nephropathy
- What is being tested?
- Other treatment, Iptacopan and Atrasentan
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2025to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will involve patients who has received Immunoglobulin A nephropathy diagnosis in US.
Who may be able to join
- Diagnosis of IgAN, regardless of symptom or treatment history
- Adult aged 18 or older; adult caregiver to an adult patient aged 18 or older; or adult caregiver to a pediatric patient under 18 years of age
- US-based with a proficient understanding of and ability to read the English language
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
United States1 site, 1 recruiting
- Recruiting
Novartis Investigational site
Boston, Massachusetts, 02108
About this study
Official title: A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US
The study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall health-related quality of life (HRQoL) experienced by Immunoglobulin A nephropathy (IgAN) patients and their caregivers.
Read the detailed description
This will be a prospective, observational study. Data will be collected using the Folia Health platform. Participation in the study will occur through use of the Folia mobile platform, where study participants will be directed to a study-specific platform environment to review and sign the consent form and enroll. Each participant will complete an initial 6-month study data collection period which includes home reported outcomes (HRO) tracking along with study specific components including a baseline survey, monthly check-in prompts, and endline study evaluation survey. After the 6-month period, participants can continue to use Folia to track their HROs for their own personal use. With their consent, the data they enter after the initial 6-month period may be reviewed for ongoing data integrations with Novartis APPRISE data platform for up to 2 years.
- Conditions
- Immunoglobulin A Nephropathy
- Being tested
- No intervention, Other treatment, Iptacopan, Atrasentan
- Keywords
- IgAN, HRQoL, Iptacopan, atrasentan, Immunoglobulin A 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.
No interventionOther
Participants and their caregivers will report home reported outcomes (HRO) data on symptom burden to understand symptom variability and health-related quality of life (HRQoL).
Other treatmentOther
Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL.
IptacopanOther
Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL including those taking iptacopan.
AtrasentanOther
Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL including those taking atrasentan.
| Study group | Role | What they receive |
|---|---|---|
| Immunoglobulin A nephropathy (IgAN)-Iptacopan | IgAN patients taking iptacopan and their caregivers Receives: Other: Iptacopan | |
| IgAN-atrasentan | IgAN patients taking atrasentan and their caregivers Receives: Other: Atrasentan | |
| IgAN-other treatment | IgAN patients taking other specific treatment and their caregivers Receives: Other: Other treatment | |
| IgAN-no treatment | IgAN patients taking none treatment and their caregivers Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with IgAN specific symptoms
To assess and gain a comprehensive understanding of the patient-reported burden of Immunoglobulin A nephropathy (IgAN) using home-reported outcome (HRO) symptom tracking data. Patients will select from a list of suggested symptoms. The 10 symptoms most frequently reported will be presented and analyzed.
Measured: monthly up to month 6
Average self-reported severity of each of these top 10 symptoms
To assess and gain a comprehensive understanding of the patient-reported burden of IgAN using HRO symptom tracking data.
Measured: monthly up to month 6
Variability in self-reported severity of each of these top 10 symptoms
To assess and gain a comprehensive understanding of the patient-reported burden of IgAN using HRO symptom tracking data.
Measured: monthly up to month 6
Secondary outcomes (12)
Average temporal frequency of treatment administration, for each IgAN-specific treatment
To characterize IgAN treatment utilization patterns.
Measured: monthly up to month 6
Number of participants by reason for skipping treatment
To identify participant reported reasons for skipping treatment.
Measured: monthly up to month 6
Differences in symptom occurrence for participants in each treatment group
Symptom occurrence (number of participants who report it) between patients in each treatment group will be presented.
Measured: monthly up to month 6
Differences in symptom severity for participants in each treatment group
Symptom severity between patients in each treatment group will be presented. Severity is measured on a 1-5 severity scale with higher numbers indicating more severe symptoms.
Measured: monthly up to month 6
Differences in symptom frequency for participants in each treatment group
To compare symptom frequency (instances of a symptom's occurrences divided by the total number of tracks) patients in each treatment group will be presented.
Measured: monthly up to month 6
Change in average symptom occurrence from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period
Change in symptom occurrence from pre- to post-iptacopan and/or atrasentan utilization, among patients receiving iptacopan and/or atrasentan.
Measured: monthly up to month 6
Change in average symptom severity from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period
Change in symptom severity from pre- to post-iptacopan and/or atrasentan utilization, among patients receiving iptacopan and/or atrasentan.
Measured: monthly up to month 6
Change in average symptom frequency from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period
Change in symptom frequency from pre- to post-iptacopan and/or atrasentan utilization, among patients receiving iptacopan and/or atrasentan.
Measured: monthly up to month 6
Number of participants in each treatment group who are classified as having a high vs moderate vs low flare burden
To compare proportion of patients classified as high, moderate, or low flare burden between patients in each treatment group.
Measured: monthly up to month 6
Change over time in monthly check-in responses assessing health-related quality of life (HRQoL), for participants in each treatment group
To compare change in monthly HRQoL between patients in each treatment group. HRQoL will be assessed qualitatively through survey questions at monthly timepoints (no PRO scale), and participants will report on missed work or school, satisfaction with treatment plan, and frequency and characteristics of patient-defined difficult days.
Measured: monthly up to month 6
Patient-reported outcome (PRO) scores for participants in each treatment group - FACIT-F
To compare change in monthly PRO scores between patients in each treatment group. The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT ranges from 0 to 52, with 0 being the worst possible score and 52 the best.
Measured: monthly up to month 6
Patient-reported outcome (PRO) scores for participants in each treatment group - EQ-5D-5L
To compare change in monthly PRO scores between patients in each treatment group.
The EQ-5D-5L consists of 2 items - a descriptive system and a visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale numbered 0 to 100 with 100 meaning the best possible health.
Measured: monthly up to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start4 Mar 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin A 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952426
- Sponsor's protocol ID
- CLNP023AUS02
- Status last verified
- Jun 2025
- First submitted
- 26 Feb 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US
- ClinicalTrials.gov ID
- NCT06952426
- Acronym / sponsor ID
- CLNP023AUS02
- Conditions
- Immunoglobulin A Nephropathy
- Keywords
- IgAN, HRQoL, Iptacopan, atrasentan, Immunoglobulin A nephropathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 Apr 2025 (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 study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall health-related quality of life (HRQoL) experienced by Immunoglobulin A nephropathy (IgAN) patients and their caregivers.
Detailed description
This will be a prospective, observational study. Data will be collected using the Folia Health platform. Participation in the study will occur through use of the Folia mobile platform, where study participants will be directed to a study-specific platform environment to review and sign the consent form and enroll. Each participant will complete an initial 6-month study data collection period which includes home reported outcomes (HRO) tracking along with study specific components including a baseline survey, monthly check-in prompts, and endline study evaluation survey. After the 6-month period, participants can continue to use Folia to track their HROs for their own personal use. With their consent, the data they enter after the initial 6-month period may be reviewed for ongoing data integrations with Novartis APPRISE data platform for up to 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Immunoglobulin A nephropathy (IgAN)-Iptacopan | – | Other: IptacopanIgAN patients taking iptacopan and their caregivers |
| IgAN-atrasentan | – | Other: AtrasentanIgAN patients taking atrasentan and their caregivers |
| IgAN-other treatment | – | Other: Other treatmentIgAN patients taking other specific treatment and their caregivers |
| IgAN-no treatment | – | Other: No interventionIgAN patients taking none treatment and their caregivers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will involve patients who has received Immunoglobulin A nephropathy diagnosis in US.
Key inclusion criteria (3 listed)
- Diagnosis of IgAN, regardless of symptom or treatment history
- Adult aged 18 or older; adult caregiver to an adult patient aged 18 or older; or adult caregiver to a pediatric patient under 18 years of age
- US-based with a proficient understanding of and ability to read the English language
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionParticipants and their caregivers will report home reported outcomes (HRO) data on symptom burden to understand symptom variability and health-related quality of life (HRQoL). | Other | IgAN-no treatment |
| Other treatmentParticipants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL. | Other | IgAN-other treatment |
| IptacopanParticipants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL including those taking iptacopan. | Other | Immunoglobulin A nephropathy (IgAN)-Iptacopan |
| AtrasentanParticipants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL including those taking atrasentan. | Other | IgAN-atrasentan |
Primary outcome
Number of participants with IgAN specific symptoms
Time frame: monthly up to month 6
To assess and gain a comprehensive understanding of the patient-reported burden of Immunoglobulin A nephropathy (IgAN) using home-reported outcome (HRO) symptom tracking data. Patients will select from a list of suggested symptoms. The 10 symptoms most frequently reported will be presented and analyzed.
Average self-reported severity of each of these top 10 symptoms
Time frame: monthly up to month 6
To assess and gain a comprehensive understanding of the patient-reported burden of IgAN using HRO symptom tracking data.
Variability in self-reported severity of each of these top 10 symptoms
Time frame: monthly up to month 6
To assess and gain a comprehensive understanding of the patient-reported burden of IgAN using HRO symptom tracking data.
12 secondary outcomes
Average temporal frequency of treatment administration, for each IgAN-specific treatment
Time frame: monthly up to month 6
Number of participants by reason for skipping treatment
Time frame: monthly up to month 6
Differences in symptom occurrence for participants in each treatment group
Time frame: monthly up to month 6
Differences in symptom severity for participants in each treatment group
Time frame: monthly up to month 6
Differences in symptom frequency for participants in each treatment group
Time frame: monthly up to month 6
Change in average symptom occurrence from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period
Time frame: monthly up to month 6
Change in average symptom severity from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period
Time frame: monthly up to month 6
Change in average symptom frequency from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period
Time frame: monthly up to month 6
Number of participants in each treatment group who are classified as having a high vs moderate vs low flare burden
Time frame: monthly up to month 6
Change over time in monthly check-in responses assessing health-related quality of life (HRQoL), for participants in each treatment group
Time frame: monthly up to month 6
Patient-reported outcome (PRO) scores for participants in each treatment group - FACIT-F
Time frame: monthly up to month 6
Patient-reported outcome (PRO) scores for participants in each treatment group - EQ-5D-5L
Time frame: monthly up to month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- 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.
Novartis Pharmaceuticals contact
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 Immunoglobulin A 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with IgAN specific symptoms (time frame: monthly up to month 6). The study lists 3 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 17 Jun 2025.