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Atrasentan in Patients With IgA Nephropathy
Not Recruiting
Trial ID: NCT04573478
Purpose
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.
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
Stanford Investigator(s)
Richard Lafayette
Professor of Medicine (Nephrology)
Eligibility
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.
- Total urine protein ≥1 g/day as measured via 24-hour urine collection by central
laboratory at Screening.
- eGFR of at least 30 mL/min/1.73 m2 at Screening based on the CKD-EPI equation.
- Willing and able to provide informed consent and comply with all study requirements.
- SGLT2i Stable Stratum Only - Receiving a stable dose of an SGLT2i (per Investigator
choice) in addition to a maximally tolerated and optimized dose of a RAS inhibitor
that has been stable for at least 12 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.
Intervention(s):
drug: Atrasentan
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Shiktj Dave
650-723-2240