Diabetic Kidney Disease Clinical Trial
— AFFINITYOfficial title:
A Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular Diseases
Verified date | May 2024 |
Source | Chinook Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 103 |
Est. completion date | July 28, 2026 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Monash Health- Monash Medical Centre | Clayton | Victoria |
Australia | Renal Research | Gosford | New South Wales |
Australia | Royal Brisbane and Women's Hospital | Herston | Queensland |
Australia | Melbourne Renal Research Group | Reservoir | Victoria |
Australia | Sunshine Hospital | St Albans | Victoria |
Australia | Royal North Shore Hospital | St. Leonards | New South Wales |
Italy | Fondazione Salvatore Maugeri IRCCS | Pavia | Lombardy |
Italy | Ospedale Pediatrico Bambino Gesu | Rome | Lazio |
Korea, Republic of | SoonChunHyang University Hospital Cheonan | Cheonan-si | Chungcheongnam-do |
Korea, Republic of | Kyung Hee University Hospital at Gangdong | Gangdong | |
Korea, Republic of | Hallym University Sacred Heart Hospital | Gyeonggi-do | |
Korea, Republic of | Korea University Anam Hospital | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University | Seoul | |
Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
Spain | Hospital Ribera Polusa | Lugo | Galicia |
Spain | Hospital General Universitario Gregorio Maranon | Madrid | |
Spain | Hospital Universitario Puerta del Hierro Majadahonda | Majadahonda | Madrid |
Spain | Hospital de Sagunto | Sagunto | Valencia |
United Kingdom | Royal Hospital London | London | England |
United Kingdom | Sheffield Teaching Hospitals NHS | Sheffield | |
United States | Mountain Kidney and Hypertension Associates | Asheville | North Carolina |
United States | Fides Clinical Research - North Atlanta Kidney Specialist | Atlanta | Georgia |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | Renal Disease Research Institute, LLC | Dallas | Texas |
United States | Colorado Kidney Care, P.C. | Denver | Colorado |
United States | Kidney Disease Medical Group | Glendale | California |
United States | NANI Research, LLC | Hinsdale | Illinois |
United States | Prolato Clinical Research Center | Houston | Texas |
United States | Apogee Clinical Research, LLC | Huntsville | Alabama |
United States | DaVita Clinical Research | Las Vegas | Nevada |
United States | Academic Medical Research Institute | Los Angeles | California |
United States | University of Minnesota Health Clinical Research Unit- A UMPhysicians Clinic | Minneapolis | Minnesota |
United States | San Antonio Kidney Disease Center Physicians Group, P.L.L.C | San Antonio | Texas |
United States | North America Research Institute | San Dimas | California |
United States | Northwest Louisiana Nephrology | Shreveport | Louisiana |
United States | Stanford University | Stanford | California |
United States | Elixia Tampa, LLC | Temple Terrace | Florida |
United States | Brookview Hills Research Associates, LLC | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Chinook Therapeutics U.S., Inc. |
United States, Australia, Italy, Korea, Republic of, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in proteinuria for IgAN, FSGS, and Alport syndrome patients receiving 0.75 mg atrasentan QD | The change in urine protein:creatinine ratio (UPCR) from baseline to Week 12 | Up to Week 12 or approximately 3 months | |
Primary | Change in albuminuria for DKD patients | The change in urine albumin:creatinine ratio (UACR) from baseline to Week 12 | Up to Week 12 or approximately 3 months | |
Primary | Change in proteinuria for FSGS patients at 1.5 mg dose | The change in urine protein:creatinine ratio (UPCR) from baseline to Week 24 | Up to Week 24 or approximately 6 months | |
Primary | Change in proteinuria for FSGS patients at 1.5 mg dose | The change in urine protein:creatinine ratio (UPCR) from baseline to Week 30 | Up to Week 30 or approximately 7.5 months |
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