Atrasentan in Patients With Proteinuric Glomerular Diseases

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    80
  • sponsor
    Chinook Therapeutics U.S., Inc.
Updated on 12 September 2021
diabetes
renal function
corticosteroids
type 2 diabetes mellitus
nephropathy
kidney function tests
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. Four initial 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 20 patients will be enrolled in each cohort (approximately 80 patients total) to receive 0.75 mg atrasentan for 52 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 Diabetic Nephropathy, Nephropathy, Focal glomerulosclerosis, IgA nephropathy, Glomerulonephritis, Autoimmune disease, Collagen disease, Alport's Syndrome, Nephritis, Collagen Vascular Diseases, Kidney Disease (Pediatric), Diabetic Nephropathy Type 2, Kidney Disease, Diabetic Kidney Disease, Focal Segmental Glomerulosclerosis
Treatment Atrasentan
Clinical Study IdentifierNCT04573920
SponsorChinook Therapeutics U.S., Inc.
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years and older for patients in the IgAN, FSGS, and Alport syndrome cohort
Screening eGFR 30 mL/min/1.73 m2
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
For patients enrolling in FSGS Cohort
Biopsy-proven FSGS or documented genetic mutation in a podocyte protein associated with FSGS
UPCR > 1.5 g/g
Subjects receiving systemic corticosteroids or calcineurin inhibitors must be on a stable dose for at least 12 weeks
BMI 40 kg/m2
Screening eGFR 30 mL/min/1.73 m2
For patients enrolling in Alport syndrome Cohort
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
UACR 0.5 g/g
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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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