Atrasentan in Patients With Proteinuric Glomerular Diseases (AFFINITY)

  • STATUS
    Recruiting
  • End date
    Feb 1, 2026
  • participants needed
    100
  • sponsor
    Chinook Therapeutics U.S., Inc.
Updated on 17 June 2022
diabetes
renal function
corticosteroids
type 2 diabetes mellitus
nephropathy
kidney function tests
immunosuppressants
type 2 diabetes
total protein
sglt2
atrasentan
ras inhibitor

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.

Description

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. Cohorts will consist of patients with:

  • IgA nephropathy (IgAN) with urine protein:creatinine ratio (UPCR) of 0.5 to less than 1.0 g/g
  • Focal segmental glomerulosclerosis (FSGS)
  • Alport syndrome
  • Diabetic kidney disease (DKD) on top of background care of a RAS inhibitor and SGLT2 inhibitor

Additional cohorts may be added as data is available.

Approximately 100 patients will be enrolled in the study. Approximately 20 patients will be enrolled in each cohort to receive 0.75 mg atrasentan QD for 52 weeks. The study will also evaluate efficacy and safety of 1.5 mg atrasentan QD in FSGS subjects who received 0.75 mg atrasentan and it was well tolerated.

Patients will be allowed to continue into treatment extension and receive oral atrasentan QD for up to an additional 84 weeks (total maximum treatment of 188 weeks),

The primary objective of the study is to evaluate the effect of atrasentan on proteinuria (for IgAN, FSGS, and Alport syndrome patients) or albuminuria (for DKD patients) levels. Exploratory objectives include evaluating the change in kidney function over time as measured by eGFR, safety and tolerability. To facilitate study participation over this time period, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered.

Details
Condition IgA Nephropathy, Focal Segmental Glomerulosclerosis, Alport Syndrome, Diabetic Kidney Disease, Diabetic Nephropathy Type 2, Immunoglobulin A Nephropathy
Treatment Atrasentan
Clinical Study IdentifierNCT04573920
SponsorChinook Therapeutics U.S., Inc.
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

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
Biopsy-proven IgA nephropathy
UPCR between 0.5 to less than 1.0 g/g
Screening eGFR ≥ 30 mL/min/1.73 m2
For patients enrolling in FSGS Cohort
Biopsy-proven FSGS or documented genetic mutation in a podocyte protein associated with FSGS
UPCR > 1.0 g/g
Screening eGFR ≥ 30 mL/min/1.73 m2
For patients enrolling in Alport syndrome Cohort
Subjects receiving systemic corticosteroids or other immunosuppressants must be on a stable dose for at least 12 weeks
BMI ≤ 40 kg/m2
Diagnosis of Alport syndrome by genetic testing
UPCR > 0.5 g/g
For patients enrolling in DKD Cohort
Diagnosis of type 2 diabetes mellitus
Screening eGFR ≥ 30 mL/min/1.73 m2
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
UACR ≥ 0.5 g/g
Screening eGFR ≥ 45 mL/min/1.73 m2

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
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
Clinical diagnosis of nephrotic syndrome
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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