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Atrasentan in Patients With Proteinuric Glomerular Diseases
Atrasentan in Patients With Proteinuric Glomerular Diseases

NCT04573920

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
  • + 3 more on CT.gov