Georgia Nephrology Research Institute | Lawrenceville, GA
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The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function.
Full description
The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function. Cohorts will consist of patients with:
Additional cohorts may be added as data is available.
Approximately 100 patients will be enrolled in the study. Approximately 20 patients will be enrolled in each cohort to receive 0.75 mg atrasentan QD for 52 weeks. The study will also evaluate efficacy and safety of 1.5 mg atrasentan QD in FSGS subjects who received 0.75 mg atrasentan and it was well tolerated.
Patients will be allowed to continue into treatment extension and receive oral atrasentan QD for up to an additional 84 weeks (total maximum treatment of 188 weeks),
The primary objective of the study is to evaluate the effect of atrasentan on proteinuria (for IgAN, FSGS, and Alport syndrome patients) or albuminuria (for DKD patients) levels. Exploratory objectives include evaluating the change in kidney function over time as measured by eGFR, safety and tolerability. To facilitate study participation over this time period, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered.
Enrollment
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Inclusion criteria
Age 18 years and older for patients in the IgAN, FSGS, and Alport Syndrome cohorts
Age 18-70 years for patients in the DKD cohort
Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks.
For patients enrolling in IgAN Cohort:
For patients enrolling in FSGS Cohort:
For patients enrolling in Alport syndrome Cohort:
For patients enrolling in DKD Cohort:
Willing and able to provide informed consent and comply with all study requirements
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
103 participants in 2 patient groups
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Central trial contact
Chinook Therapeutics
Data sourced from clinicaltrials.gov
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