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Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy (ASSIST)

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ClinicalTrials.gov Identifier: NCT05834738
Recruitment Status : Recruiting
First Posted : April 28, 2023
Last Update Posted : August 21, 2023
Sponsor:
Information provided by (Responsible Party):
Chinook Therapeutics, Inc.

Study Description
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Brief Summary:
The ASSIST study is a phase 2, double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of atrasentan vs. placebo in subjects with IgA nephropathy (IgAN) while on background standard of care therapy and an SGLT2 inhibitor (SGLT2i).

Condition or disease Intervention/treatment Phase
IgA Nephropathy Immunoglobulin A Nephropathy Drug: Atrasentan Drug: Placebo Phase 2

Detailed Description:

Approximately 52 patients with biopsy-proven IgAN on a background SGLT2i and a maximally tolerated and stable dose of a renin-angiotensin system (RAS) inhibitor [such as angiotensin converting enzyme inhibitor (ACEi) or angiotensin-receptor antagonist (ARB)] as part of standard of care, will be randomized to either sequence AB or sequence BA in which they will receive 0.75 mg atrasentan once daily during one period (period A), complete a 12-week washout period, and then receive matching placebo during the other period (period B) as determined by the randomization schema.

Subjects who are not on background SGLT2i therapy must be willing to undergo a run-in period of 8 weeks with an SGLT2i.

The primary objective of the study is to evaluate the efficacy of atrasentan vs. placebo while on background therapy with SGLT2i.

Subjects will have safety and efficacy assessments for 1 year (52 weeks).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy on Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i)
Actual Study Start Date : July 20, 2023
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sequence AB
Once daily oral administration of 0.75 mg atrasentan for 12 weeks (Period A) followed by once daily oral administration of placebo for 24 weeks (Period B)
 Drug: Atrasentan
Period A (12 Weeks) - Film-coated tablet, Washout Period: 12 weeks, Period B (24 Weeks) - Placebo
Other Names:
  • CHK-01
  • Atrasentan Hydrochloride
  • ABT-627

Drug: Placebo
Placebo
Experimental: Sequence BA
Once daily oral administration of placebo for 12 weeks (Period B) followed by once daily oral administration of 0.75 mg atrasentan for 24 weeks (Period A)
 Drug: Atrasentan
Period B (12 Weeks) - Placebo, Washout Period: 12 weeks, Period A (24 Weeks) - Film-coated tablet
Other Names:
  • CHK-01
  • Atrasentan Hydrochloride
  • ABT-627

Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change in proteinuria [ Time Frame: Up to 12 weeks or approximately 3 months ]
    The change in urine protein: creatinine ratio (UPCR) from baseline to Week 12


Secondary Outcome Measures :
  1. Change in proteinuria at 24 weeks of treatment [ Time Frame: 24 weeks or approximately 6 months ]
    The change in UPCR from baseline to Week 24


Eligibility Criteria
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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:

  • Subjects aged 18 and older at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
  • Biopsy-proven IgA nephropathy.
  • Receiving a maximally tolerated and stable dose of RAS inhibitor therapy (ACEi or ARB) for at least 12 weeks prior to screening. Investigator discretion should be used in determining maximally tolerated and stable dose.
  • eGFR of at least 30 mL/min/1.73 m2 at screening based on the CKD-EPI equation.
  • Willing to agree to highly effective forms of contraception, as specified in the protocol, throughout the study and for up to 1 month afterward. In WOCBP, use of hormonal contraceptive agents must have been started at least 1 month prior to baseline.
  • Willing and able to provide informed consent and comply with all study requirements.

  • Inclusion Criteria for SGLT2i stable subjects

    • Receiving a stable dose of an SGLT2i for at least 8 weeks prior to screening
    • Must have a 24-hour urine protein of >0.5 grams/day.

  • Inclusion Criteria for Run-In Subjects

    • Must have a 24-hour total urine protein of >0.85 grams/day at screening
    • Willing to participate in an 8-week run-in period with an SGLT2i (per Investigator choice)

  • Additional Inclusion Criteria for Run-in Subjects at the end of Run-In

    • Must have completed the 8-week run-in period on a stable and well tolerated dose of an SGLT2i
    • Must have a 24-hour total urine protein of >0.5 grams/day confirmed at the Week -1 Visit
    • Must have an eGFR of ≥ 30 mL/min/1.73 m2 based on the CKD-EPI equation at the Week -1 Visit
  • Receiving treatment with SGLT2i at a stable dose for at least 8 weeks prior to screening.

Exclusion Criteria:

  • Current diagnosis with another chronic kidney disease, including diabetic kidney disease.
  • History of kidney transplantation or other organ transplantation.
  • 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.
  • Known 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 prior history of blood transfusion for anemia within the past 3 months.
  • Malignancy within the past 5 years. Exceptions to this criteria include nonmelanoma skin cancer and curatively treated cervical carcinoma in situ.
  • For women, pregnancy, breast feeding, or intent to become pregnant during the study. and at least 1 month afterward.
  • For men, intent to father a child or donate sperm during the study.
  • Have received any investigational agent or approved treatment for IgAN (other than a RAS inhibitor) including SGLT2i (except for subjects in the SGLT2i stable stratum) within 1 month (or 5 half-lives of the agent, whichever is longer) prior to Screening. If the investigational agent is a cytotoxic or immunosuppressive agent then this washout period is 6 months.
Contacts and Locations
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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): NCT05834738


Contacts
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Contact: Chinook Therapeutics 2064857051 clinicaltrials@chinooktx.com

Locations
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United States, North Carolina
University of North Carolina at Chapel Hill - Nephrology and Hypertension Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Anne Froment    919-966-4131    anne_froment@med.unc.edu   
Principal Investigator: Amy Mottl         
Sponsors and Collaborators
Chinook Therapeutics, Inc.
Investigators
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Study Director: Charlotte Jones-Burton, MD, MS SVP, Product Development & Strategy
More Information
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Responsible Party: Chinook Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05834738    
Other Study ID Numbers: CHK01-03
First Posted: April 28, 2023    Key Record Dates
Last Update Posted: August 21, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chinook Therapeutics, Inc.:
Kidney Diseases
Kidney Disease, Chronic
Urologic Diseases
Glomerulonephritis
 Glomerular Disease
Glomerulonephritis, IGA
Glomerulopathy
Immunoglobulin Disease
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Glomerulonephritis
 Nephritis
Autoimmune Diseases
Immune System Diseases
Atrasentan
Antineoplastic Agents
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action