NCT06952426 · Novartis Pharmaceuticals
A Mobile App-Based Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
No intervention
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
Other treatment
Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL.
OTHER
Iptacopan
Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL including those taking iptacopan.
OTHER
Atrasentan
Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL including those taking atrasentan.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2025 · Source of record for eligibility and locations