Atrasentan in Patients With Proteinuric Glomerular Diseases
AFFINITY
A Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular Diseases
1 other identifier
interventional
103
6 countries
33
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2021
Longer than P75 for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedStudy Start
First participant enrolled
March 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2026
ExpectedAugust 11, 2025
August 1, 2025
3.3 years
September 28, 2020
August 8, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Change in proteinuria for IgAN, FSGS, and Alport syndrome patients receiving 0.75 mg atrasentan QD
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 12
Up to Week 12 or approximately 3 months
Change in albuminuria for DKD patients
The change in urine albumin:creatinine ratio (UACR) from baseline to Week 12
Up to Week 12 or approximately 3 months
Change in proteinuria for FSGS patients at 1.5 mg dose
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 24
Up to Week 24 or approximately 6 months
Change in proteinuria for FSGS patients at 1.5 mg dose
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 30
Up to Week 30 or approximately 7.5 months
Study Arms (2)
Atrasentan 0.75 mg
EXPERIMENTALOnce daily oral administration of 0.75 mg atrasentan
Atrasentan 1.5 mg
EXPERIMENTALOnce daily oral administration 1.5 mg atrasentan (FSGS cohorts only)
Interventions
Film-coated tablet
Eligibility Criteria
You may qualify if:
- 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:
- Biopsy-proven IgA nephropathy
- UPCR between 0.5 to less than 1.0 g/g
- Screening eGFR ≥ 30 mL/min/1.73 m2
- For patients enrolling in FSGS Cohort:
- Biopsy-proven FSGS or documented genetic mutation in a podocyte protein associated with FSGS
- UPCR \> 1.0 g/g
- Screening eGFR ≥ 30 mL/min/1.73 m2
- Subjects receiving systemic corticosteroids or other immunosuppressants must be on a stable dose for at least 12 weeks.
- BMI ≤ 40 kg/m2
- For patients enrolling in Alport syndrome Cohort:
- Diagnosis of Alport syndrome by genetic testing
- +8 more criteria
You may not qualify if:
- Current diagnosis of another cause of chronic kidney disease or another primary glomerulopathy.
- History of kidney transplantation or other organ transplantation.
- Except for FSGS patients, use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months.
- Blood pressure above 150 mmHg systolic or 95 mmHg diastolic as evaluated by the Investigator.
- History of heart failure or a previous hospital admission for fluid overload.
- Clinically significant history of liver disease as assessed by the Investigator.
- Hemoglobin below 9 g/dL as measured by the Investigator or blood transfusion for anemia within the past 3 months.
- Clinical diagnosis of nephrotic syndrome
- Malignancy within the past 5 years. Exception to the criteria include nonmelanoma skin cancer and curatively treated cervical carcinoma in situ.
- For women, pregnant, breastfeeding, or intent to become pregnant during the study.
- For men, intent to father a child or donate sperm during the study.
- Recently received an investigational agent.
- Clinically significant unstable or uncontrolled medical condition as assessed by the Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Kidney Disease Medical Group
Glendale, California, 91206, United States
Academic Medical Research Institute
Los Angeles, California, 90022, United States
North America Research Institute
San Dimas, California, 91773, United States
Stanford U School Of Medicine
Stanford, California, 94305, United States
Colorado Kidney Care
Denver, Colorado, 80230, United States
Northwest Louisiana Nephrology Research
Shreveport, Louisiana, 71101-4440, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Uni of Minnesota Hos and Clinics
Minneapolis, Minnesota, 55455, United States
DaVita Clinical Research
Las Vegas, Nevada, 89146, United States
Mountain Kidney And Hyper Associa
Asheville, North Carolina, 28801, United States
Brookview Hills Research Assoc
Winston-Salem, North Carolina, 27103, United States
Baylor Scott and White
Dallas, Texas, 75246, United States
Prolato Clinical Research Center
Houston, Texas, 77054, United States
Milwaukee Nephrologists SC
Wauwatosa, Wisconsin, 53226, United States
Novartis Investigative Site
Gosford, New South Wales, 2250, Australia
Novartis Investigative Site
Herston, Queensland, 4029, Australia
Novartis Investigative Site
Clayton, Victoria, 3168, Australia
Novartis Investigative Site
Reservoir, Victoria, 3073, Australia
Novartis Investigative Site
St Albans, Victoria, 3021, Australia
Novartis Investigative Site
St Leonards, 2065, Australia
Novartis Investigative Site
Roma, RM, 00165, Italy
Novartis Investigative Site
Cheonan, Chungcheongnam-do, 330-721, South Korea
Novartis Investigative Site
Anyang-si, Gyeonggi-do, 14068, South Korea
Novartis Investigative Site
Seoul, 02841, South Korea
Novartis Investigative Site
Seoul, 03722, South Korea
Novartis Investigative Site
Seoul, 134 727, South Korea
Novartis Investigative Site
Barcelona, Catalonia, 08035, Spain
Novartis Investigative Site
Port de Sagunt, Valencia, 46520, Spain
Novartis Investigative Site
Lugo, 27004, Spain
Novartis Investigative Site
Madrid, 28009, Spain
Novartis Investigative Site
Majadahonda, 28222, Spain
Novartis Investigative Site
Sheffield, South Yorkshire, S10 2JF, United Kingdom
Novartis Investigative Site
London, E1 1BB, United Kingdom
Related Publications (3)
Rheault MN. Treatment Approaches for Alport Syndrome. J Am Soc Nephrol. 2025 Sep 12;37(1):172-9. doi: 10.1681/ASN.0000000897. Online ahead of print.
PMID: 40938675DERIVEDLin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available.
PMID: 39899371DERIVEDObadina M, Wilson S, Derebail VK, Little J. Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations. Kidney360. 2023 Jul 1;4(7):997-1005. doi: 10.34067/KID.0000000000000162. Epub 2023 May 31.
PMID: 37254256DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2020
First Posted
October 5, 2020
Study Start
March 15, 2021
Primary Completion
July 2, 2024
Study Completion (Estimated)
October 27, 2026
Last Updated
August 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share