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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.
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
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 below
Select...
My kidney function test shows an eGFR of 30 or higher.
Select...
I have been on a stable dose of RAS inhibitor therapy for at least 12 weeks or cannot tolerate it.
Select...
My kidney function test shows an eGFR of 30 or higher.
Select...
I have been on a stable dose of SGLT2i and RAS inhibitor for at least 12 weeks.

ALIGN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2.6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2.6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in proteinuria
Secondary outcome measures
Change in eGFR
Percent of subjects meeting the first composite endpoint
Percent of subjects meeting the second composite endpoint
Other outcome measures
Change in proteinuria (UPCR)

Side effects data

From 2018 Phase 2 trial • 20 Patients • NCT02118714
20%
OEDEMA PERIPHERAL
20%
NASOPHARYNGITIS
10%
HEADACHE
10%
DIABETIC KETOACIDOSIS
10%
DIARRHOEA
10%
NON-CARDIAC CHEST PAIN
10%
DYSPNOEA
5%
BLOOD CREATININE INCREASED
5%
ORTHOSTATIC HYPERTENSION
5%
HAEMORRHAGIC ANAEMIA
5%
AORTIC DISSECTION
5%
HYPOKALAEMIA
5%
HYPOMAGNESAEMIA
5%
TINEA CRURIS
5%
DIABETES MELLITUS
5%
GASTRITIS
5%
TOOTH FRACTURE
5%
POST PROCEDURAL INFLAMMATION
5%
BRONCHITIS
5%
PNEUMONIA
5%
TOOTH INFECTION
5%
LEFT VENTRICULAR HYPERTROPHY
5%
ANGINA PECTORIS
5%
NAUSEA
5%
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
5%
TOOTH DISORDER
5%
BLOOD PRESSURE INCREASED
5%
RESPIRATORY DISTRESS
5%
ANAEMIA
5%
WHITE BLOOD CELL COUNT INCREASED
5%
FLUID OVERLOAD
5%
PAIN IN EXTREMITY
5%
POSTOPERATIVE RESPIRATORY FAILURE
5%
LOCALISED INFECTION
5%
BACK PAIN
5%
RESPIRATORY FAILURE
5%
CHEST INJURY
5%
EUSTACHIAN TUBE DYSFUNCTION
5%
UPPER GASTROINTESTINAL HAEMORRHAGE
5%
HYPERTRIGLYCERIDAEMIA
5%
VOMITING
5%
WEIGHT INCREASED
5%
HYPOGLYCAEMIA
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
Once daily oral administration of 0.75 mg atrasentan for 132 weeks
Group II: PlaceboPlacebo Group1 Intervention
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

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
Shuping Yang, MDStudy DirectorChinook Therapeutics U.S., Inc.
Alan Glicklich, M.D.Study DirectorChief Medical Officer
2 Previous Clinical Trials
203 Total Patients Enrolled
1 Trials studying Immunoglobulin A Nephropathy
100 Patients Enrolled for Immunoglobulin A Nephropathy

Media Library

Atrasentan (Endothelin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04573478 — Phase 3
Immunoglobulin A Nephropathy Research Study Groups: Atrasentan, Placebo
Immunoglobulin A Nephropathy Clinical Trial 2023: Atrasentan Highlights & Side Effects. Trial Name: NCT04573478 — Phase 3
Atrasentan (Endothelin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04573478 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Atrasentan a common medication in other research trials?

"There are two ongoing studies of atrasentan, one of which is in phase 3. The majority of research on atrasentan is conducted in St. Leonards, New South Wales; however, there are a total of 158 locations worldwide where research on atrasentan is being conducted."

Answered by AI

Have procedures like this been done before?

"Since 2020, Atrasentan has been the focus of various clinical trials. After the first trial in 2020-- which was conducted by Chinook Therapeutics U.S., Inc. and included 380 participants-- Phase 3 approval was given. As of now, there are 2 active trials involving Atrasentan being carried out in 43 cities and 17 countries."

Answered by AI

Has Atrasentan undergone testing by the Food and Drug Administration?

"Atrasentan has undergone Phase 3 clinical trials, which is the highest level of support for efficacy and safety."

Answered by AI

Are there any slots still available for potential participants in this clinical trial?

"This trial, which was first posted on December 11th 2020 and last edited on August 17th 2022, is actively recruiting participants according to clinicaltrials.gov."

Answered by AI
~89 spots leftby Mar 2025