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Endothelin Receptor Antagonist
Atrasentan for IgA Nephropathy (ASSIST Trial)
Phase 2
Recruiting
Research Sponsored by Chinook Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects aged 18 and older at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures
eGFR of at least 30 mL/min/1.73 m2 at screening based on the CKD-EPI equation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks or approximately 6 months
Awards & highlights
ASSIST Trial Summary
This trial will study how safe & effective atrasentan is for people with IgA nephropathy who are taking an SGLT2 inhibitor.
Who is the study for?
Adults with IgA Nephropathy who have significant protein in their urine can join this trial. They must be on stable doses of specific kidney medications and agree to use effective contraception. Excluded are those with heart failure, other chronic kidney diseases, recent cancer (except certain skin or cervical cancers), blood pressure issues, severe liver disease, organ transplants, or recent immunosuppressant use.Check my eligibility
What is being tested?
The ASSIST study is testing Atrasentan against a placebo in patients with IgA Nephropathy already taking standard care and an SGLT2 inhibitor. It's a phase 2 trial where participants will switch between the drug and placebo at different times without knowing which one they're taking.See study design
What are the potential side effects?
Possible side effects of Atrasentan may include fluid retention leading to swelling or weight gain, nasal congestion, heart problems like irregular heartbeat or chest pain, and gastrointestinal symptoms such as nausea.
ASSIST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years or older and have signed the consent form.
Select...
My kidney function is adequate, with an eGFR of at least 30.
ASSIST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks or approximately 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks or approximately 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in proteinuria
Secondary outcome measures
Change in proteinuria at 24 weeks of treatment
ASSIST Trial Design
2Treatment groups
Experimental Treatment
Group I: Sequence BAExperimental Treatment2 Interventions
Once daily oral administration of placebo for 12 weeks (Period B) followed by once daily oral administration of 0.75 mg atrasentan for 24 weeks (Period A)
Group II: Sequence ABExperimental Treatment2 Interventions
Once daily oral administration of 0.75 mg atrasentan for 12 weeks (Period A) followed by once daily oral administration of placebo for 24 weeks (Period B)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atrasentan
2011
Completed Phase 3
~420
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Chinook Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
576 Total Patients Enrolled
1 Trials studying Immunoglobulin A Nephropathy
292 Patients Enrolled for Immunoglobulin A Nephropathy
Yasmin Brahmbhatt, MD, FASNStudy DirectorMedical Director, Clinical Development
Yasmin Brahmbhatt, MD, FAFNStudy DirectorMedical Director, Clinical Development
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a chronic kidney condition, such as diabetic kidney disease.I have been on a stable, high dose of blood pressure medication for at least 12 weeks.Your kidney function, measured by eGFR, must be at least 30 mL/min/1.73 m2 before the study starts.I have not taken immunosuppressants like steroids for more than 2 weeks in the last 3 months.My hemoglobin is below 9 g/dL or I've had a blood transfusion for anemia in the last 3 months.You need to have more than 0.5 grams of protein in your urine in a day.Your urine has to have more than 0.5 grams of protein in a day, as confirmed during the Week -1 visit.I have been on a stable dose of SGLT2 inhibitors for at least 8 weeks.I have been on a stable dose of SGLT2 inhibitors for 8 weeks without issues.I haven't taken any experimental or approved IgAN treatments, except RAS inhibitors, recently.I have been on a stable dose of an SGLT2 inhibitor for at least 8 weeks.I have had cancer in the last 5 years, but not skin cancer or treated cervical cancer.You need to have more than 0.85 grams of protein in your urine in a day.I have a history of heart failure or was hospitalized for fluid buildup.I do not plan to father a child or donate sperm during the study.I am 18 years or older and have signed the consent form.I am willing to try a specific diabetes medication for 8 weeks.Your blood pressure is higher than 150 over 95.I have a significant history of liver problems.My kidney function is adequate, with an eGFR of at least 30.You have been diagnosed with IgA nephropathy through a biopsy.I have had a kidney or other organ transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Sequence AB
- Group 2: Sequence BA
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Sequence BA been granted authorization by the FDA yet?
"Sequence BA received a score of 2 because there is evidence for its safety, but no data yet exists to demonstrate efficacy."
Answered by AI
Is this trial currently enlisting participants?
"Affirmative. Clinicaltrials.gov attests that this clinical trial posted on July 20th, 2023 is currently seeking participants. 52 test subjects are needed from 1 medical facility."
Answered by AI
How extensive is the recruitment for this clinical research project?
"Affirmative, the clinicaltrials.gov platform attests that this medical study is actively seeking participants. It was initially uploaded on July 20th of 2023 and later amended in August 17th of the same year. The trial needs to recruit 52 patients from one site."
Answered by AI
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