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
Condition(s) studied
IgA NephropathyFocal Segmental GlomerulosclerosisAlport SyndromeDiabetic Kidney DiseaseDiabetic Nephropathy Type 2Immunoglobulin A Nephropathy
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
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)
- Change in proteinuria for IgAN, FSGS, and Alport syndrome patients receiving 0.75 mg atrasentan QD — Up to Week 12 or approximately 3 months
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 12 - Change in albuminuria for DKD patients — Up to Week 12 or approximately 3 months
The change in urine albumin:creatinine ratio (UACR) from baseline to Week 12 - Change in proteinuria for FSGS patients at 1.5 mg dose — Up to Week 24 or approximately 6 months
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 24 - Change in proteinuria for FSGS patients at 1.5 mg dose — Up to Week 30 or approximately 7.5 months
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 30
Trial sites (33)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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