Atrasentan in Patients With IgA Nephropathy (ALIGN)
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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 |
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Recruitment Status :
Recruiting
First Posted : October 5, 2020
Last Update Posted : April 9, 2021
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| 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 |
| 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 |
| Actual Study Start Date : | December 11, 2020 |
| Estimated Primary Completion Date : | December 1, 2023 |
| Estimated Study Completion Date : | December 1, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Atrasentan
Once daily oral administration of 0.75 mg atrasentan for 132 weeks
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Drug: Atrasentan
Film-coated tablet
Other Names:
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Placebo Comparator: Placebo
Once daily oral administration of placebo for 132 weeks
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Drug: Placebo
Film-coated tablet |
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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) 485-7051 | clinicaltrials@chinooktx.com |
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| Study Director: | Alan Glicklich, M.D. | Chief Medical Officer |
| 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: | April 9, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Kidney Diseases Kidney Disease, Chronic Urologic Diseases Glomerulonephritis |
Glomerular Disease Glomerulonephritis, IGA Glomerulopathy Immunoglobulin Disease |
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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 |