What side effects are associated with this type of intervention?

Common treatments for Immunoglobulin A Nephropathy (IgAN) include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), corticosteroids, and immunosuppressive agents. ACE inhibitors and ARBs can cause side effects such as hyperkalemia, hypotension, and renal dysfunction. Corticosteroids are associated with weight gain, hypertension, hyperglycemia, and increased risk of infections. Immunosuppressive agents like cyclophosphamide can lead to bone marrow suppression, increased infection risk, and potential bladder toxicity. Endothelin Receptor Antagonists, like Atrasentan, may cause fluid retention, edema, and potential heart failure exacerbation.

What prior FDA approvals exist?

The FDA has approved several treatments for Immunoglobulin A Nephropathy (IgAN), primarily focusing on managing symptoms and slowing disease progression. These include angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) to reduce proteinuria and control blood pressure. While Atrasentan, an endothelin receptor antagonist, is currently being studied in clinical trials for its efficacy in treating IgAN, there are no specific FDA-approved endothelin receptor antagonists for IgAN as of now. Other treatments under investigation include immunosuppressive therapies and novel agents targeting different pathways involved in the disease.

What other types of research exist?

Promising novel alternatives to Atrasentan for IgA Nephropathy patients include: 1) Sparsentan, a dual endothelin receptor and angiotensin II receptor antagonist, which has shown positive results in clinical trials. 2) Nefecon, a targeted-release formulation of budesonide, which has demonstrated efficacy in reducing proteinuria in IgAN patients. 3) Rituximab, a monoclonal antibody targeting CD20, which has been explored for its potential benefits in IgAN. Patients should discuss these options with their healthcare provider to determine the most appropriate treatment based on their individual condition.

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Endothelin Receptor Antagonist

Atrasentan for IgA Nephropathy (ALIGN Trial)

Phase 3

Waitlist Available

Research Sponsored by Chinook Therapeutics, 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

Must not have

Current diagnosis with another chronic kidney disease, including diabetic kidney disease

History of kidney transplantation or other organ transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2.6 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called atrasentan to help people with a kidney disease called IgA nephropathy. It aims to protect their kidneys by reducing protein in their urine. The study will compare atrasentan to another treatment over a few years. Atrasentan has been studied for its effects on reducing protein in urine and protecting kidney function in patients with diabetic 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function test shows an eGFR of 30 or higher.

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My kidney function test shows an eGFR of 30 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a chronic kidney disease, such as diabetic kidney disease.

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I have had a kidney or other organ transplant.

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I have not used immunosuppressants like steroids for more than 2 weeks in the last 3 months.

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I have a history of heart failure or was hospitalized for fluid buildup.

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My hemoglobin is below 9 g/dL or I've had a blood transfusion for anemia in the last 3 months.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study and for 1 month after.

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I do not plan to father a child or donate sperm during the study.

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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Other study objectives

Change in proteinuria (UPCR)

Side effects data

From 2018 Phase 2 trial • 20 Patients • NCT02118714

20%

OEDEMA PERIPHERAL

20%

NASOPHARYNGITIS

10%

DIABETIC KETOACIDOSIS

10%

DIARRHOEA

10%

HEADACHE

10%

NON-CARDIAC CHEST PAIN

10%

DYSPNOEA

POSTOPERATIVE RESPIRATORY FAILURE

ANAEMIA

HAEMORRHAGIC ANAEMIA

ANGINA PECTORIS

EUSTACHIAN TUBE DYSFUNCTION

CHEST INJURY

RESPIRATORY DISTRESS

RESPIRATORY FAILURE

AORTIC DISSECTION

TINEA CRURIS

FLUID OVERLOAD

ORTHOSTATIC HYPERTENSION

TOOTH DISORDER

TOOTH INFECTION

HYPOGLYCAEMIA

HYPOKALAEMIA

NAUSEA

VOMITING

LOCALISED INFECTION

LEFT VENTRICULAR HYPERTROPHY

GASTRITIS

BRONCHITIS

POST PROCEDURAL INFLAMMATION

DIABETES MELLITUS

BACK PAIN

UPPER GASTROINTESTINAL HAEMORRHAGE

HYPERTRIGLYCERIDAEMIA

PAIN IN EXTREMITY

BLOOD CREATININE INCREASED

PNEUMONIA

TOOTH FRACTURE

BLOOD PRESSURE INCREASED

WEIGHT INCREASED

PERIPHERAL ARTERIAL OCCLUSIVE DISEASE

WHITE BLOOD CELL COUNT INCREASED

HYPOMAGNESAEMIA

FLANK PAIN

CARDIOGENIC SHOCK

OSTEOMYELITIS

DELIRIUM TREMENS

DEPRESSION

PANIC ATTACK

ACUTE KIDNEY INJURY

HAEMATURIA

POLLAKIURIA

PULMONARY OEDEMA

DENTAL PROSTHESIS USER

AORTIC ANEURYSM

HAEMATOMA

HYPERTENSION

HYPERTENSIVE CRISIS

100%

80%

60%

40%

20%

Study treatment Arm

Atrasentan

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 9Eligibility criteria met

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.