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), glucocorticoids, and mycophenolate mofetil (MMF). ACE inhibitors and ARBs are generally well-tolerated but can cause side effects such as hyperkalemia, hypotension, and renal function deterioration. Glucocorticoids can lead to serious adverse events, including infections, weight gain, hypertension, and osteoporosis, especially at high doses. MMF may cause gastrointestinal disturbances, leukopenia, and increased risk of infections. Atrasentan, an endothelin receptor antagonist, is being studied for its efficacy and safety in proteinuric glomerular diseases, and similar agents may cause fluid retention, nasal congestion, and potential liver function abnormalities.

What prior FDA approvals exist?

The FDA has approved several treatments for Immunoglobulin A (IgA) Nephropathy, primarily focusing on reducing proteinuria and slowing disease progression. These include angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), which are commonly used to manage proteinuria and hypertension in IgA nephropathy patients. Additionally, immunosuppressive therapies such as corticosteroids are used in more severe cases. The AFFINITY Study is investigating atrasentan, an endothelin receptor antagonist, which represents a novel approach in targeting proteinuric glomerular diseases, including IgA nephropathy.

What other types of research exist?

Promising novel alternatives to Atrasentan for treating Immunoglobulin A Nephropathy include Rituximab, which has been studied for its efficacy in various glomerular diseases, and intravenous immunoglobulins (IVIG), which have been used in combination with Rituximab for transplant glomerulopathy. Both therapies target the immune system and have shown potential in managing proteinuric glomerular diseases.

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Endothelin Receptor Antagonist

Atrasentan for Kidney Disease (AFFINITY Trial)

Phase 2

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

Age 18-70 years for patients in the DKD cohort

Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks.

Timeline

Screening 30 days

Treatment 4 months

Follow Up 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a pill called atrasentan that may help people with certain kidney diseases by reducing harmful protein levels in their urine. It targets patients whose kidney function is getting worse despite standard treatments. The goal is to see if this medication can protect their kidneys.

Who is the study for?

This trial is for adults with certain kidney diseases (like IgA Nephropathy, FSGS, Alport Syndrome) who have protein in their urine and are at risk of worsening kidney function. Participants must meet specific criteria including age limits (18+ or 18-70 depending on the condition), a confirmed diagnosis through biopsy, stable blood filtration rates, and be on steady doses of certain diabetes or blood pressure medications.

What is being tested?

The AFFINITY Study is testing Atrasentan's effectiveness and safety in patients with different types of proteinuric glomerular diseases. It's an open-label phase 2 study which means everyone knows they're getting Atrasentan and it’s early in the drug testing process to see if it works well.

What are the potential side effects?

While not specified here, drugs like Atrasentan could potentially cause fluid retention leading to swelling, heart problems or weight gain; nasal congestion; low red blood cell count (anemia); fatigue; and possibly impact liver function.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 70 years old.

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I have been on a stable dose of RAS inhibitor therapy for at least 12 weeks.

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Your body mass index (BMI) is less than or equal to 40 kg/m2.

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I have been diagnosed with type 2 diabetes.

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I have been on a steady dose of an SGLT2 inhibitor for 3 months.

Timeline

Screening ~ 30 days1 visit

Treatment ~ 4 months0 visits

Follow Up ~ 1 month2 visits

Screening ~ 30 days

Treatment ~ 4 months

Follow Up ~1 month

This trial's timeline: 30 days for screening, 4 months for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in albuminuria for DKD patients

Change in proteinuria for FSGS patients at 1.5 mg dose

Change in proteinuria for IgAN, FSGS, and Alport syndrome patients receiving 0.75 mg atrasentan QD

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Atrasentan 1.5 mgExperimental Treatment1 Intervention

Once daily oral administration 1.5 mg atrasentan (FSGS cohorts only)

Group II: Atrasentan 0.75 mgExperimental Treatment1 Intervention

Once daily oral administration of 0.75 mg atrasentan

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atrasentan

2011

Completed Phase 3

~420

0 / 6Eligibility 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 angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), which work by reducing proteinuria and controlling blood pressure, thereby slowing the progression of kidney damage. Atrasentan, an endothelin receptor antagonist, is being studied for its potential to further reduce proteinuria by blocking the effects of endothelin-1, a molecule that contributes to kidney inflammation and fibrosis. These treatments are vital for IgAN patients as they help preserve kidney function and delay the onset of end-stage kidney disease.