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Clinical Trials in the UK / NCT04573920
Active, not recruiting Phase 2

Atrasentan in Patients With Proteinuric Glomerular Diseases

NCT04573920 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2021-03-15
Last updated
2026-06-01

Condition(s) studied

IgA NephropathyFocal Segmental GlomerulosclerosisAlport SyndromeDiabetic Kidney DiseaseDiabetic Nephropathy Type 2Immunoglobulin A Nephropathy

Investigational drug(s) / intervention(s)

Atrasentan

Atrasentan: Film-coated tablet

Study summary

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (33)

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

More Novartis Pharmaceuticals trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04573920 on ClinicalTrials.gov ↗ ← All trials in the UK