Have you been diagnosed with IgA nephropathy?
The ASSIST study is a phase 2, randomized, placebo-controlled, cross-over study of atrasentan* in adults with IgA nephropathy (IgAN).
The ASSIST study is a clinical trial that will test an investigational drug named atrasentan, which is being developed for the treatment of IgAN, along with an SGLT2 inhibitor (SGLT2i) **. IgAN is the most common immune-mediated disease affecting the kidneys. One-third of all people with IgAN develop ESKD (End-stage kidney disease).
No treatments are fully effective in preventing disease progression and so combination therapy will likely be important. The goal of the study is to evaluate the safety and tolerance of atrasentan along with an SGLT2i in reducing proteinuria and slowing down kidney disease progression.
Approximately 52 adults will take part in the study. The study will be conducted worldwide. Participation in the study lasts one year. Participants who qualify may be reimbursed for their time and travel costs for taking part in the clinical study.
This study will have 2 treatment parts:
Study Treatment Part 1 and Study Treatment Part 2. The researchers will randomly (like the flip of a coin) assign who takes atrasentan and who takes the placebo during Part 1. This is done so that the study treatments are assigned fairly.
After the Study Treatment Part 1, you will stop taking study treatment for 12 weeks. This is called a washout period. This is done so that the first study treatment can leave your body before you take your second study treatment. This helps the researchers understand if effects they see during each treatment part of this study are related to the study treatment. During this time, you will continue to take an SGLT2i. In Part 2, you will take the study treatment that you did not take in Part 1.
You may qualify to participate in this study if you are 18 years or older and:
- Have been diagnosed with IgAN by kidney biopsy
- Receiving a maximum tolerated and stable ACEi or ARB ≥ 12 weeks prior to screening
- Have an eGFR ≥ 30 mL/min/1.73 m2 at screening
- For patients already on a stable SGLT2i
- Receiving SGLT2i at stable dose ≥ 8 weeks prior to screening
- 24-hour total urine protein > 0.5 g/d at screening
- For patients never having taken an SGLT2i
- 24-hour total urine protein > 0.85 g/d at screening
- Complete 8-week run-in period on a stable and well-tolerated dose of an SGLT2i
- Fertile men and women of childbearing potential must be willing to abide with highly effective forms of contraception.
To learn more information about the ASSIST Study, visit https://clinicaltrials.gov/ct2/show/NCT05834738