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Atrasentan for IgA Nephropathy (ALIGN Trial)
ALIGN Trial Summary
This trial is testing if atrasentan is better than placebo at slowing down kidney function loss in people with IgA nephropathy.
ALIGN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowALIGN Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 20 Patients • NCT02118714ALIGN Trial Design
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Who is running the clinical trial?
Media Library
- I have a significant history of liver problems.I have had cancer in the last 5 years, but not skin cancer or treated cervical cancer.You have more than 1 gram of protein in your urine per day, as measured by a 24-hour urine collection test.I haven't taken any experimental or approved IgAN treatments, except RAS inhibitors, recently.My kidney function test shows an eGFR of 30 or higher.I have been on a stable dose of RAS inhibitor therapy for at least 12 weeks or cannot tolerate it.You have more than 1 gram of protein in your urine in a day.I have been on a stable dose of RAS inhibitor therapy for at least 12 weeks or cannot tolerate it.I have a history of heart failure or was hospitalized for fluid buildup.I am not pregnant, breastfeeding, nor planning to become pregnant during the study and for 1 month after.My kidney function test shows an eGFR of 30 or higher.Your blood pressure is higher than 150 over 95.My hemoglobin is below 9 g/dL or I've had a blood transfusion for anemia in the last 3 months.I do not plan to father a child or donate sperm during the study.You have been diagnosed with IgA nephropathy through a kidney biopsy.I have a chronic kidney disease, such as diabetic kidney disease.I have had a kidney or other organ transplant.I have not used immunosuppressants like steroids for more than 2 weeks in the last 3 months.You are willing and able to provide informed consent and comply with all study requirements.I have been on a stable dose of SGLT2i and RAS inhibitor for at least 12 weeks.You have been diagnosed with IgA nephropathy through a kidney biopsy.I have been on a stable dose of SGLT2i and RAS inhibitor for at least 12 weeks.
- Group 1: Atrasentan
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is Atrasentan a common medication in other research trials?
"There are two ongoing studies of atrasentan, one of which is in phase 3. The majority of research on atrasentan is conducted in St. Leonards, New South Wales; however, there are a total of 158 locations worldwide where research on atrasentan is being conducted."
Have procedures like this been done before?
"Since 2020, Atrasentan has been the focus of various clinical trials. After the first trial in 2020-- which was conducted by Chinook Therapeutics U.S., Inc. and included 380 participants-- Phase 3 approval was given. As of now, there are 2 active trials involving Atrasentan being carried out in 43 cities and 17 countries."
Has Atrasentan undergone testing by the Food and Drug Administration?
"Atrasentan has undergone Phase 3 clinical trials, which is the highest level of support for efficacy and safety."
Are there any slots still available for potential participants in this clinical trial?
"This trial, which was first posted on December 11th 2020 and last edited on August 17th 2022, is actively recruiting participants according to clinicaltrials.gov."
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