Atrasentan in Patients With IgA Nephropathy

  • STATUS
    Recruiting
  • End date
    Dec 1, 2025
  • participants needed
    320
  • sponsor
    Chinook Therapeutics U.S., Inc.
Updated on 22 August 2021
renal function
nephropathy

Summary

The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function.

Description

Approximately 320 patients with biopsy-proven IgAN will be randomized to receive 0.75 mg atrasentan or placebo daily for 132 weeks. Subjects receive a maximally tolerated and stable dose of a RAS (renin-angiotensin system) inhibitor (such as angiotensin converting enzyme inhibitor (ACEi) or angiotensin-receptor antagonist (ARB)) as part of standard of care. An exception will be made for subjects who are unable to tolerate RAS inhibitor therapy.

The primary objective of the study is to evaluate the effect of atrasentan versus placebo on proteinuria as measured by UPCR. Secondary and tertiary objectives include evaluating the change in kidney function over time as measured by eGFR, safety and tolerability, as well as quality of life.

Subjects will have assessments of safety and efficacy over 2 years. 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.

Subjects who complete the study may be eligible to enroll in an extension study to receive open-label treatment with atrasentan under a separate protocol.

Details
Condition IgA nephropathy, Glomerulonephritis, Autoimmune disease
Treatment Placebo, Atrasentan
Clinical Study IdentifierNCT04573478
SponsorChinook Therapeutics U.S., Inc.
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Biopsy-proven IgA nephropathy
Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks. Exceptions from this requirement will be made for subjects who are unable to tolerate RAS inhibitor therapy
Urine protein creatinine ratio 1 g/g
eGFR of at least 30 mL/min/1.73 m2
Willing and able to provide informed consent and comply with all study requirements

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
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. Exceptions to this criteria include nonmelanoma skin cancer and curatively treated cervical carcinoma in situ
For women, pregnant, breast feeding, 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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