Atrasentan in Patients With Proteinuric Glomerular Diseases

Running, not enrolling · Phase 2

Conditions studied: IgA Nephropathy, Focal Segmental Glomerulosclerosis, Alport Syndrome, Diabetic Kidney Disease, Diabetic Nephropathy Type 2, Immunoglobulin A Nephropathy

In brief

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.

Key facts

Study ID

NCT04573920

Run by

Novartis Pharmaceuticals

People needed

103

Starts

2021-03-15

Expected to finish

2026-10-27

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• UPCR > 0.5 g/g
• Screening eGFR ≥ 30 mL/min/1.73 m2
• For patients enrolling in DKD Cohort:
• Diagnosis of type 2 diabetes mellitus
• UACR ≥ 0.5 g/g
• Screening eGFR ≥ 45 mL/min/1.73 m2
• Receiving a stable dose of SGLT2 inhibitor for at least 12 weeks
• Willing and able to provide informed consent and comply with all study requirements

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.

Where it is running

• Kidney Disease Medical Group — Glendale, California, United States
• Academic Medical Research Institute — Los Angeles, California, United States
• North America Research Institute — San Dimas, California, United States
• Stanford U School Of Medicine — Stanford, California, United States
• Colorado Kidney Care Nephrology — Denver, Colorado, United States
• Northwest Louisiana Nephrology Research — Shreveport, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Uni of Minnesota Hos and Clinics — Minneapolis, Minnesota, United States
• DaVita Clinical Research — Las Vegas, Nevada, United States
• Mountain Kidney And Hyper Associa — Asheville, North Carolina, United States
• Brookview Hills Research Assoc — Winston-Salem, North Carolina, United States
• Baylor Scott and White — Dallas, Texas, United States
• Prolato Clinical Research Center — Houston, Texas, United States
• Milwaukee Nephrologists SC — Wauwatosa, Wisconsin, United States
• Novartis Investigative Site — Gosford, New South Wales, Australia
• Novartis Investigative Site — Herston, Queensland, Australia
• Novartis Investigative Site — Clayton, Victoria, Australia
• Novartis Investigative Site — Reservoir, Victoria, Australia
• Novartis Investigative Site — St Albans, Victoria, Australia
• Novartis Investigative Site — St Leonards, Australia
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Cheonan, Chungcheongnam-do, South Korea
• Novartis Investigative Site — Anyang-si, Gyeonggi-do, South Korea
• Novartis Investigative Site — Seoul, Korea, South Korea
• Novartis Investigative Site — Seoul, South Korea

Full record on ClinicalTrials.gov

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