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
|Condition or disease||Intervention/treatment||Phase|
|IgA Nephropathy Immunoglobulin A Nephropathy||Drug: Atrasentan Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Once daily oral administration of 0.75 mg atrasentan for 132 weeks
Placebo Comparator: Placebo
Once daily oral administration of placebo for 132 weeks
- 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
- Change in eGFR [ Time Frame: Up to week 136 or approximately 2.6 years ]Change from baseline to end of study in eGFR
- 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
- 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
- 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
- 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
- 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
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
|Contact: Chinook Therapeutics||(206) email@example.com|
|Study Director:||Alan Glicklich, M.D.||Chief Medical Officer|