Atrasentan in Patients With Proteinuric Glomerular Diseases (AFFINITY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04573920|
Recruitment Status : Not yet recruiting
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|IgA Nephropathy Focal Segmental Glomerulosclerosis Alport Syndrome Diabetic Kidney Disease Diabetic Nephropathy Type 2 Immunoglobulin A Nephropathy||Drug: Atrasentan||Phase 2|
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. Four initial cohorts will consist of patients with:
- IgA nephropathy (IgAN) with urine protein:creatinine ratio (UPCR) of 0.5 to less than 1.0 g/g
- Focal segmental glomerulosclerosis (FSGS)
- Alport syndrome
- Diabetic kidney disease (DKD) on top of background care of a RAS inhibitor and SGLT2 inhibitor
Additional cohorts may be added as data is available.
Approximately 20 patients will be enrolled in each cohort (approximately 80 patients total) to receive 0.75 mg atrasentan for 52 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular Diseases|
|Estimated Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2023|
Once daily oral administration of 0.75 mg atrasentan for 52 weeks.
- Change in proteinuria for IgAN, FSGS, and Alport syndrome patients [ Time Frame: Up to Week 12 or approximately 3 months ]The change in urine protein:creatinine ratio (UPCR) from baseline to Week 12
- Change in albuminuria for DKD patients [ Time Frame: Up to Week 12 or approximately 3 months ]The change in urine albumin:creatinine ratio (UACR) from baseline to Week 12
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04573920
|Contact: Chinook Therapeutics||(206) firstname.lastname@example.org|
|Study Director:||Alan Glicklich, M.D.||Chief Medical Officer|