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Atrasentan in Patients With IgA Nephropathy (ALIGN)

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: NCT04573478
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 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.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Immunoglobulin A Nephropathy Drug: Atrasentan Drug: Placebo Phase 3

Detailed 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 ½ 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Atrasentan
Once daily oral administration of 0.75 mg atrasentan for 132 weeks
Drug: Atrasentan
Film-coated tablet
Other Names:
  • CHK-01
  • Atrasentan Hydrochloride
  • ABT-627

Placebo Comparator: Placebo
Once daily oral administration of placebo for 132 weeks
Drug: Placebo
Film-coated tablet




Primary Outcome Measures :
  1. Change in proteinuria [ Time Frame: Up to Week 24 or approximately 6 months ]
    The change in urine protein:creatinine ratio (UPCR) from baseline to Week 24


Secondary Outcome Measures :
  1. Change in eGFR [ Time Frame: Up to week 136 or approximately 2.6 years ]
    Change from baseline to end of study in eGFR

  2. Rate of change in eGFR [ Time Frame: Up to week 120 or approximately 2.3 years ]
    Rate of change in eGFR during 2 years on treatment at Week 12 through to Week 120

  3. Rate of change in eGFR [ Time Frame: Up to week 136 or approximately 2.6 years ]
    Rate of change in eGFR during the study from baseline to Week 136

  4. Percent of subjects with specified proteinuria/UPCR change [ Time Frame: Up to week 136 or approximately 2.6 years ]
    Percent of subjects achieving proteinuria < 1 g/day at Week 24 and 40% reduction in UPCR from baseline

  5. Percent of subjects experiencing specified eGFR decline or end stage kidney disease (ESKD) [ Time Frame: Up to week 136 or approximately 2.6 years ]
    Percent of subjects experiencing at least a 30% reduction in eGFR or reach ESKD during the study

  6. Percent of subjects experiencing specified eGFR decline or end stage kidney disease [ Time Frame: Up to week 136 or approximately 2.6 years ]
    Percent of subjects experiencing at least a 40% reduction in eGFR or reach ESKD during the study



Information from the National Library of Medicine

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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:

  • 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.

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): NCT04573478


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: NCT04573478    
Other Study ID Numbers: CHK01-01
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
Keywords provided by Chinook Therapeutics U.S., 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
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Atrasentan
Antineoplastic Agents
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action