Education and Training
Atrasentan in Patients With IgA Nephropathy
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Atrasentan
- drug: Placebo
Eligibility
Inclusion Criteria:
Double-Blind period:
- 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 m^2 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.
- All fertile men and WOCBP who engage in heterosexual intercourse must be willing to
abide with highly effective forms of contraception, as specified in the protocol,
throughout the study and for 1 month afterward. In WOCBP, use of contraceptive agents
must have been started at least 1 month prior to Baseline.
Open-Label Period:
- Willing and able to provide informed consent and comply with all OL extension study
visits and study procedures.
- Completed treatment through Week 132 and completed the Week 136 visit.
- All fertile men and WOCBP who engage in heterosexual intercourse must be willing to
abide with highly effective forms of contraception, as specified in the protocol,
throughout the study and for 1 month afterward. In WOCBP, use of contraceptive agents
must have been continued after completing the double-blind portion of the study.
Exclusion Criteria:
Double-blind period:
- Concurrent diagnosis of another cause of chronic kidney disease including diabetic
kidney disease or another primary glomerulopathy.
- Clinical diagnosis of nephrotic syndrome.
- BNP value of > 200 pg/mL at Screening.
- Platelet count <80,000 per μL at Screening.
- History of organ transplantation (subjects with history of corneal transplant are not
excluded).
- Use of systemic immunosuppressant medications.
- Hemoglobin below 9 g/dL at Screening or prior history of blood transfusion for anemia
within 3 months of Screening.
Open-label period:
- eGFR < 25 mL/min/1.73m^2 or evidence of rapidly decreasing eGFR, including unrecovered
acute kidney injury or expected to require renal replacement therapy within 3 months
- BNP value of > 200 pg/mL at OL Screening.
- Platelet count < 80,000 per μL at OL Screening.
- Hemoglobin below 9 g/dL at OL screening or prior history of blood transfusion for
anemia within 3 months of OL Screening.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Shiktj Dave
650-723-2240
Not Recruiting