Atrasentan in Patients With Proteinuric Glomerular Diseases

Trial ID or NCT#

NCT04573920

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular Diseases

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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: 1. Biopsy-proven IgA nephropathy 2. UPCR between 0.5 to less than 1.0 g/g 3. Screening eGFR ≥ 30 mL/min/1.73 m2 - For patients enrolling in FSGS Cohort: 1. Biopsy-proven FSGS or documented genetic mutation in a podocyte protein associated with FSGS 2. UPCR > 1.0 g/g 3. Screening eGFR ≥ 30 mL/min/1.73 m2 4. Subjects receiving systemic corticosteroids or other immunosuppressants must be on a stable dose for at least 12 weeks. 5. BMI ≤ 40 kg/m2 - For patients enrolling in Alport syndrome Cohort: 1. Diagnosis of Alport syndrome by genetic testing 2. UPCR > 0.5 g/g 3. Screening eGFR ≥ 30 mL/min/1.73 m2 - For patients enrolling in DKD Cohort: 1. Diagnosis of type 2 diabetes mellitus 2. UACR ≥ 0.5 g/g 3. Screening eGFR ≥ 45 mL/min/1.73 m2 4. 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
Exclusion Criteria:
  1. - 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.
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Investigator(s)

Richard Lafayette
Richard Lafayette
Nephrologist
Professor of Medicine (Nephrology)

Contact us to find out if this trial is right for you.

Contact

Shiktj Dave
650-723-2240

View on ClinicalTrials.gov