Atrasentan in Patients With IgA Nephropathy (NCT04573478) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Atrasentan in Patients With IgA Nephropathy
United States, Argentina, Australia404 participantsStarted 2020-12-11
Plain-language summary
The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Double-Blind period:
* Biopsy-proven IgA nephropathy.
* Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks. Exceptions from this requirement will be made for subjects who are unable to tolerate RAS inhibitor therapy.
* Total urine protein ≥1 g/day as measured via 24-hour urine collection by central laboratory at Screening.
* eGFR of at least 30 mL/min/1.73 m\^2 at Screening based on the CKD-EPI equation.
* Willing and able to provide informed consent and comply with all study requirements.
* SGLT2i Stable Stratum Only - Receiving a stable dose of an SGLT2i (per Investigator choice) in addition to a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to Screening.
* All fertile men and WOCBP who engage in heterosexual intercourse must be willing to abide with highly effective forms of contraception, as specified in the protocol, throughout the study and for 1 month afterward. In WOCBP, use of contraceptive agents must have been started at least 1 month prior to Baseline.
Open-Label Period:
* Willing and able to provide informed consent and comply with all OL extension study visits and study procedures.
* Completed treatment through Week 132 and completed the Week 136 visit.
* All fertile men and WOCBP who engage in heterosexual intercourse must be willing to abide with highly effective forms of contraception, as specified in the pro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Double-blind period: Change in proteinuria
Timeframe: Up to Week 36 or approximately 9 months
2
Open-label period: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From open-label baseline up to end of treatment visit, up to 48 weeks
3
Open-label period: Number of Subjects With Adverse Events of Special Interest (AESI) Including Events of Fluid Overload
Timeframe: From open-label baseline up to end of treatment visit, up to 48 weeks
4
Substudy period: Number of subjects with TEAEs
Timeframe: From substudy baseline to end of treatment, up to 48 weeks
5
Substudy period: Number of subjects with AESI
Timeframe: From substudy baseline to end of treatment, up to 48 weeks