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Atrasentan in Patients With Proteinuric Glomerular Diseases (AFFINITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04573920
Recruitment Status : Not yet recruiting
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Chinook Therapeutics U.S., Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Focal Segmental Glomerulosclerosis Alport Syndrome Diabetic Kidney Disease Diabetic Nephropathy Type 2 Immunoglobulin A Nephropathy Drug: Atrasentan Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular Diseases
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2023


Arm Intervention/treatment
Experimental: Atrasentan
Once daily oral administration of 0.75 mg atrasentan for 52 weeks.
Drug: Atrasentan
Film-coated tablet
Other Names:
  • CHK-01
  • Atrasentan Hydrochloride
  • ABT-627




Primary Outcome Measures :
  1. Change in proteinuria for IgAN, FSGS, and Alport syndrome patients [ Time Frame: Up to Week 12 or approximately 3 months ]
    The change in urine protein:creatinine ratio (UPCR) from baseline to Week 12

  2. Change in albuminuria for DKD patients [ Time Frame: Up to Week 12 or approximately 3 months ]
    The change in urine albumin:creatinine ratio (UACR) from baseline to Week 12



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years and older
  • Screening eGFR ≥ 30 mL/min/1.73 m2
  • 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
  • For patients enrolling in FSGS Cohort:

    1. Biopsy-proven FSGS or documented genetic mutation in a podocyte protein associated with FSGS
    2. UPCR ≥ 1.5 g/g
    3. Subjects receiving systemic corticosteroids or calcineurin inhibitors must be on a stable dose for at least 12 weeks.
    4. 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
  • For patients enrolling in DKD Cohort:

    1. Diagnosis of type 2 diabetes mellitus
    2. UACR ≥ 0.5 g/g
    3. 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04573920


Contacts
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Contact: Chinook Therapeutics (206) 485-7051 clinicaltrials@chinooktx.com

Sponsors and Collaborators
Chinook Therapeutics U.S., Inc.
Investigators
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Study Director: Alan Glicklich, M.D. Chief Medical Officer
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Responsible Party: Chinook Therapeutics U.S., Inc.
ClinicalTrials.gov Identifier: NCT04573920    
Other Study ID Numbers: CHK01-02
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Glomerulonephritis, IGA
Glomerulosclerosis, Focal Segmental
Nephritis, Hereditary
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Urogenital Abnormalities
Congenital Abnormalities
Collagen Diseases
Connective Tissue Diseases
Atrasentan
Antineoplastic Agents
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action