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Endothelin Receptor Antagonist

Atrasentan for Kidney Disease (AFFINITY Trial)

Phase 2
Recruiting
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 months
Awards & highlights

AFFINITY Trial Summary

This trial is studying how well atrasentan works in treating patients with proteinuric glomerular disease.

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.Check my eligibility
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.See study design
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.

AFFINITY Trial 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.

AFFINITY Trial Timeline

Screening ~ 30 days
Treatment ~ 4 months
Follow Up ~1 months
This trial's timeline: 30 days for screening, 4 months for treatment, and 1 months 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 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%
NASOPHARYNGITIS
20%
OEDEMA PERIPHERAL
10%
HEADACHE
10%
NON-CARDIAC CHEST PAIN
10%
DIABETIC KETOACIDOSIS
10%
DIARRHOEA
10%
DYSPNOEA
5%
BLOOD CREATININE INCREASED
5%
ORTHOSTATIC HYPERTENSION
5%
AORTIC DISSECTION
5%
HYPOKALAEMIA
5%
HYPOMAGNESAEMIA
5%
DIABETES MELLITUS
5%
GASTRITIS
5%
UPPER GASTROINTESTINAL HAEMORRHAGE
5%
FLUID OVERLOAD
5%
BACK PAIN
5%
EUSTACHIAN TUBE DYSFUNCTION
5%
CHEST INJURY
5%
WEIGHT INCREASED
5%
TOOTH FRACTURE
5%
HYPERTRIGLYCERIDAEMIA
5%
ANAEMIA
5%
LOCALISED INFECTION
5%
TINEA CRURIS
5%
PNEUMONIA
5%
BLOOD PRESSURE INCREASED
5%
WHITE BLOOD CELL COUNT INCREASED
5%
PAIN IN EXTREMITY
5%
POSTOPERATIVE RESPIRATORY FAILURE
5%
RESPIRATORY DISTRESS
5%
TOOTH DISORDER
5%
HYPOGLYCAEMIA
5%
NAUSEA
5%
LEFT VENTRICULAR HYPERTROPHY
5%
POST PROCEDURAL INFLAMMATION
5%
TOOTH INFECTION
5%
BRONCHITIS
5%
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
5%
RESPIRATORY FAILURE
5%
HAEMORRHAGIC ANAEMIA
5%
ANGINA PECTORIS
5%
VOMITING
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

AFFINITY 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

Find a Location

Who is running the clinical trial?

Chinook Therapeutics U.S., Inc.Lead Sponsor
1 Previous Clinical Trials
380 Total Patients Enrolled
1 Trials studying Immunoglobulin A Nephropathy
380 Patients Enrolled for Immunoglobulin A Nephropathy
Charlotte Jones-Burton, M.D.Study DirectorSenior Vice President, Product Development and Strategy
2 Previous Clinical Trials
139 Total Patients Enrolled
Alan Glicklich, M.D.Study DirectorChief Medical Officer
2 Previous Clinical Trials
483 Total Patients Enrolled
1 Trials studying Immunoglobulin A Nephropathy
380 Patients Enrolled for Immunoglobulin A Nephropathy

Media Library

Atrasentan (Endothelin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04573920 — Phase 2
Immunoglobulin A Nephropathy Research Study Groups: Atrasentan 0.75 mg, Atrasentan 1.5 mg
Immunoglobulin A Nephropathy Clinical Trial 2023: Atrasentan Highlights & Side Effects. Trial Name: NCT04573920 — Phase 2
Atrasentan (Endothelin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04573920 — Phase 2
Immunoglobulin A Nephropathy Patient Testimony for trial: Trial Name: NCT04573920 — Phase 2

Frequently Asked Questions

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

Has a similar trial been conducted before?

"In 2020, Atrasentan was firstly investigated by Chinook Therapeutics U.S., Inc.. Subsequent to this initial trial of 380 participants, it attained its Phase 3 endorsement. Nowadays there are two in-progress trials for Atrasentan taking place across 17 countries and 43 cities."

Answered by AI

How many geographic areas are encompassing this clinical trial?

"This research is being conducted in 18 distinct clinics. Locations include Temple Terrace, Winston-Salem and El Paso to mention a few. To lessen the strain of potential travel expenses, it may be beneficial to choose a medical centre closest to your home if you decide to partake."

Answered by AI

Has Atrasentan been granted acceptance by the Federal Drug Administration?

"Early clinical data suggests that Atrasentan is safe, leading our team at Power to rate it as a 2 on the safety scale. While there has been some evaluation of its security, no studies have yet evaluated its efficacy."

Answered by AI

How many participants have been accepted into this medical trial so far?

"In order for the Chinook Therapeutics U.S., Inc.-sponsored trial to commence, 100 eligible patients must first be recruited from designated medical centres such as Elixia Tampa, LLC in Temple Terrace, Florida and Brookview Hills Research Associates, LLC in Winston-Salem, North carolina."

Answered by AI

Are there currently any openings in this clinical research program?

"The information hosted on clinicaltrials.gov confirms that this study is actively seeking participants as of July 25th 2022, having first been posted on February 1st 2021."

Answered by AI

Are there any precedential trials involving Atrasentan?

"Currently, two trials for Atrasentan are in progress. One is already on Phase 3; the other trial sites span 158 locations around St Leonards, New South Wales."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
Texas
California
Other
How old are they?
18 - 65
What site did they apply to?
Comprehensive Research Institute
North America Research Institute
University of Minnesota Health Clinical Research Unit- A UMPhysicians Clinic
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

My conditions getting worse. I'm getting pretty good relief taking Lyrica.
PatientReceived no prior treatments
I'm seeking relief from the pain of neuropathy! I am doing everything to lower my A1c and nothing us working I loose a bit of weight but I get stuck there, I exercise eat right and nothing works.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. University of Minnesota Health Clinical Research Unit- A UMPhysicians Clinic: < 48 hours
Average response time
  • < 2 Days
~24 spots leftby Mar 2025