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Atrasentan in Patients With Proteinuric Glomerular Diseases
Atrasentan in Patients With Proteinuric Glomerular Diseases
Active Not RecruitingPhase 2
Sponsor: Novartis Pharmaceuticals
Conditions: IgA Nephropathy, Focal Segmental Glomerulosclerosis, Alport Syndrome, Diabetic Kidney Disease, Diabetic Nephropathy Type 2
Interventions: Atrasentan
Countries: United States, Australia, Italy, South Korea, Spain, United Kingdom
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.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * 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: * 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.
Locations (33)
- Glendale, California, United States
- Los Angeles, California, United States
- San Dimas, California, United States
- Stanford, California, United States
- Denver, Colorado, United States
- Shreveport, Louisiana, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Las Vegas, Nevada, United States
- Asheville, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Wauwatosa, Wisconsin, United States
- Gosford, New South Wales, Australia
- Herston, Queensland, Australia
- Clayton, Victoria, Australia
- Reservoir, Victoria, Australia
- St Albans, Victoria, Australia
- St Leonards, Australia
- Roma, RM, Italy
- Cheonan, Chungcheongnam-do, South Korea
- Anyang-si, Gyeonggi-do, South Korea
- Seoul, Korea, South Korea
- Seoul, South Korea
- Seoul, South Korea
- Port de Sagunt, Valencia, Spain
- Barcelona, Spain
- Lugo, Spain
- Madrid, Spain
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