Atrasentan in Patients With IgA Nephropathy

About

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase III

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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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