Atrasentan in Patients With Proteinuric Glomerular Diseases

Korábbi kezelés

• Except for FSGS patients, use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months.
• History of heart failure or a previous hospital admission for fluid overload.
• Recently received an investigational agent.

Más betegség

• Current diagnosis of another cause of chronic kidney disease or another primary glomerulopathy.
• History of kidney transplantation or other organ transplantation.
• Clinically significant history of liver disease as assessed by the Investigator.
• 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.
• Clinically significant unstable or uncontrolled medical condition as assessed by the Investigator.

Laborértékek

• Hemoglobin below 9 g/dL as measured by the Investigator or blood transfusion for anemia within the past 3 months.

Egyéb

• Blood pressure above 150 mmHg systolic or 95 mmHg diastolic as evaluated by the Investigator.
• 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.

• 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