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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04573920
Recruitment Status : Active, not recruiting
First Posted : October 5, 2020
Last Update Posted : May 23, 2024
Sponsor:
Information provided by (Responsible Party):
Chinook Therapeutics, Inc. ( Chinook Therapeutics U.S., Inc. )

Tracking Information
First Submitted Date  ICMJE September 28, 2020
First Posted Date  ICMJE October 5, 2020
Last Update Posted Date May 23, 2024
Actual Study Start Date  ICMJE February 1, 2021
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2024)
  • Change in proteinuria for IgAN, FSGS, and Alport syndrome patients receiving 0.75 mg atrasentan QD [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to Week 30 or approximately 7.5 months ]
    The change in urine protein:creatinine ratio (UPCR) from baseline to Week 30
Original Primary Outcome Measures  ICMJE
 (submitted: September 28, 2020)
  • 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
  • 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atrasentan in Patients With Proteinuric Glomerular Diseases
Official Title  ICMJE A Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular Diseases
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.
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. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • IgA Nephropathy
  • Focal Segmental Glomerulosclerosis
  • Alport Syndrome
  • Diabetic Kidney Disease
  • Diabetic Nephropathy Type 2
  • Immunoglobulin A Nephropathy
Intervention  ICMJE Drug: Atrasentan
Film-coated tablet
Other Names:
  • CHK-01
  • Atrasentan Hydrochloride
  • ABT-627
Study Arms  ICMJE
  • Experimental: Atrasentan 0.75 mg
    Once daily oral administration of 0.75 mg atrasentan
    Intervention: Drug: Atrasentan
  • Experimental: Atrasentan 1.5 mg
    Once daily oral administration 1.5 mg atrasentan (FSGS cohorts only)
    Intervention: Drug: Atrasentan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 1, 2024)
103
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2020)
80
Estimated Study Completion Date  ICMJE July 28, 2026
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Italy,   Korea, Republic of,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04573920
Other Study ID Numbers  ICMJE CHK01-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Chinook Therapeutics, Inc. ( Chinook Therapeutics U.S., Inc. )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Chinook Therapeutics U.S., Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Chinook Therapeutics, Inc.
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP