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Endothelin Receptor Antagonist
Atrasentan for IgA Nephropathy (ALIGN Trial)
Phase 3
Waitlist Available
Research Sponsored by Chinook Therapeutics U.S., Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
eGFR of at least 30 mL/min/1.73 m2 at Screening based on the CKD-EPI equation.
eGFR of at least 30 mL/min/1.73 m2 at Screening based on the CKD-EPI equation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2.6 years
Awards & highlights
ALIGN Trial Summary
This trial is testing if atrasentan is better than placebo at slowing down kidney function loss in people with IgA nephropathy.
Who is the study for?
This trial is for adults with IgA Nephropathy, a kidney disease, who have a certain level of kidney function and are on stable doses of specific blood pressure medications. They must not be pregnant or planning to become so during the study. People with high blood pressure, severe anemia, recent cancer (except some skin cancers), other chronic kidney diseases, or those who've had organ transplants can't join.Check my eligibility
What is being tested?
The ALIGN Study is testing Atrasentan against a placebo in patients at risk of worsening kidney function due to IgA Nephropathy. It's a phase 3 trial where participants won't know if they're getting the actual drug or a dummy pill (placebo). The goal is to see if Atrasentan is effective and safe.See study design
What are the potential side effects?
While the side effects for this specific trial aren't listed here, Atrasentan may commonly cause fluid retention leading to swelling in legs and weight gain; it might also affect heart health by causing congestive heart failure.
ALIGN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function test shows an eGFR of 30 or higher.
Select...
My kidney function test shows an eGFR of 30 or higher.
ALIGN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2.6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2.6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Double-blind period: Change in proteinuria
Open-label period: Number of Subjects With Adverse Events of Special Interest (AESI) Including Events of Fluid Overload
Open-label period: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome measures
Double-blind period: Change in eGFR
Double-blind period: Number of Subjects With AESI Including Events of Fluid Overload
Double-blind period: Number of Subjects With TEAEs
+5 moreOther outcome measures
Change in proteinuria (UPCR)
Side effects data
From 2018 Phase 2 trial • 20 Patients • NCT0211871420%
OEDEMA PERIPHERAL
20%
NASOPHARYNGITIS
10%
DIARRHOEA
10%
HEADACHE
10%
NON-CARDIAC CHEST PAIN
10%
DIABETIC KETOACIDOSIS
10%
DYSPNOEA
5%
VOMITING
5%
TOOTH DISORDER
5%
POST PROCEDURAL INFLAMMATION
5%
DIABETES MELLITUS
5%
HYPERTRIGLYCERIDAEMIA
5%
TINEA CRURIS
5%
HAEMORRHAGIC ANAEMIA
5%
TOOTH INFECTION
5%
CHEST INJURY
5%
WEIGHT INCREASED
5%
BLOOD PRESSURE INCREASED
5%
WHITE BLOOD CELL COUNT INCREASED
5%
PAIN IN EXTREMITY
5%
LEFT VENTRICULAR HYPERTROPHY
5%
HYPOKALAEMIA
5%
GASTRITIS
5%
UPPER GASTROINTESTINAL HAEMORRHAGE
5%
BLOOD CREATININE INCREASED
5%
HYPOGLYCAEMIA
5%
NAUSEA
5%
PNEUMONIA
5%
TOOTH FRACTURE
5%
ORTHOSTATIC HYPERTENSION
5%
RESPIRATORY FAILURE
5%
FLUID OVERLOAD
5%
ANGINA PECTORIS
5%
LOCALISED INFECTION
5%
HYPOMAGNESAEMIA
5%
BACK PAIN
5%
ANAEMIA
5%
POSTOPERATIVE RESPIRATORY FAILURE
5%
EUSTACHIAN TUBE DYSFUNCTION
5%
BRONCHITIS
5%
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
5%
RESPIRATORY DISTRESS
5%
AORTIC DISSECTION
5%
FLANK PAIN
5%
CARDIOGENIC SHOCK
5%
OSTEOMYELITIS
5%
DELIRIUM TREMENS
5%
DEPRESSION
5%
PANIC ATTACK
5%
ACUTE KIDNEY INJURY
5%
HAEMATURIA
5%
POLLAKIURIA
5%
PULMONARY OEDEMA
5%
DENTAL PROSTHESIS USER
5%
AORTIC ANEURYSM
5%
HAEMATOMA
5%
HYPERTENSION
5%
HYPERTENSIVE CRISIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atrasentan
ALIGN Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AtrasentanExperimental Treatment1 Intervention
Double-blind Period: Once daily oral administration of 0.75 mg atrasentan for 132 weeks.
Open-label Extension Period: Once daily oral administration of 0.75 mg atrasentan for 48 weeks after completion of 132 weeks on atrasentan or placebo.
Group II: PlaceboPlacebo Group1 Intervention
Double-blind Period: Once daily oral administration of placebo for 132 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atrasentan
2011
Completed Phase 3
~420
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Immunoglobulin A Nephropathy (IgAN) include endothelin receptor antagonists like atrasentan, ACE inhibitors, and ARBs. Atrasentan works by blocking the endothelin-1 receptor, which reduces proteinuria and inflammation in the kidneys.
ACE inhibitors and ARBs lower blood pressure and reduce proteinuria by inhibiting the renin-angiotensin-aldosterone system, which decreases glomerular pressure and protein leakage. These mechanisms are crucial for IgAN patients as they help to slow the progression of kidney damage, reduce the risk of end-stage kidney disease, and improve overall kidney function.
Find a Location
Who is running the clinical trial?
Chinook Therapeutics U.S., Inc.Lead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Immunoglobulin A Nephropathy
100 Patients Enrolled for Immunoglobulin A Nephropathy
Novartis PharmaceuticalsStudy DirectorNovartis Pharmaceuticals
2,166 Previous Clinical Trials
4,013,977 Total Patients Enrolled
1 Trials studying Immunoglobulin A Nephropathy
52 Patients Enrolled for Immunoglobulin A Nephropathy
Shuping Yang, MDStudy DirectorChinook Therapeutics U.S., Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a significant history of liver problems.I have had cancer in the last 5 years, but not skin cancer or treated cervical cancer.You have more than 1 gram of protein in your urine per day, as measured by a 24-hour urine collection test.I haven't taken any experimental or approved IgAN treatments, except RAS inhibitors, recently.My kidney function test shows an eGFR of 30 or higher.I have been on a stable dose of RAS inhibitor therapy for at least 12 weeks or cannot tolerate it.You have more than 1 gram of protein in your urine in a day.I have been on a stable dose of RAS inhibitor therapy for at least 12 weeks or cannot tolerate it.I have a history of heart failure or was hospitalized for fluid buildup.I am not pregnant, breastfeeding, nor planning to become pregnant during the study and for 1 month after.My kidney function test shows an eGFR of 30 or higher.Your blood pressure is higher than 150 over 95.My hemoglobin is below 9 g/dL or I've had a blood transfusion for anemia in the last 3 months.I do not plan to father a child or donate sperm during the study.You have been diagnosed with IgA nephropathy through a kidney biopsy.I have a chronic kidney disease, such as diabetic kidney disease.I have had a kidney or other organ transplant.I have not used immunosuppressants like steroids for more than 2 weeks in the last 3 months.You are willing and able to provide informed consent and comply with all study requirements.I have been on a stable dose of SGLT2i and RAS inhibitor for at least 12 weeks.You have been diagnosed with IgA nephropathy through a kidney biopsy.I have been on a stable dose of SGLT2i and RAS inhibitor for at least 12 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Atrasentan
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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