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Angiotensin Receptor Blocker

Sparsentan for Focal Segmental Glomerulosclerosis (DUPLEX Trial)

Phase 3
Waitlist Available
Research Sponsored by Travere Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biopsy-proven focal segmental glomerulosclerosis (FSGS) lesion(s) or documentation of a genetic mutation in a podocyte protein associated with FSGS
eGFR ≥30 mL/min/1.73 m2 at screening
Must not have
FSGS secondary to another condition
History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 6 to week 108
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the kidney-protecting potential of sparsentan vs. an angiotensin receptor blocker in patients with primary or genetic FSGS.

Who is the study for?
This trial is for individuals with primary or genetic FSGS, a kidney disease. Participants must be between 8-75 years old, weigh over 20 kg, and have certain levels of protein in their urine. Women who can bear children should agree to use reliable contraception methods. People with secondary FSGS, uncontrolled diabetes, significant liver disease, recent cancer (except some skin/cervical cancers), extreme obesity related to FSGS, drug abuse history or severe reactions to specific heart medications cannot join.
What is being tested?
The study compares the long-term kidney protection effects of Sparsentan against Irbesartan in patients with FSGS. It aims to see if Sparsentan is better at preserving kidney function over time compared to the current treatment option.
What are the potential side effects?
Potential side effects may include issues similar to other blood pressure medications like dizziness or lightheadedness due to lowered blood pressure. There could also be risks associated with long-term medication use such as changes in kidney function or potassium levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a confirmed diagnosis of FSGS through a biopsy or genetic test.
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My kidney function is adequate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My FSGS is caused by another health condition.
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I have not had cancer, except for certain skin cancers or cervical cancer, in the last 2 years.
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I am pregnant, planning to become pregnant, or am breastfeeding.
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My kidney disease is not caused by primary or genetic FSGS.
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I have a history of heart or major blood vessel diseases.
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I have a serious liver condition.
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I am extremely obese and it's linked to my FSGS condition.
Select...
My kidney disease has progressed to the point where I need dialysis or a transplant.
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I have type 1 diabetes, uncontrolled type 2 diabetes, or my blood sugar is often above 180 mg/dL.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 6 to week 108
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 6 to week 108 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Achieving FSGS Partial Remission Endpoint (FPRE)
Slope of Estimated Glomerular Filtration Rate (eGFR)
Secondary study objectives
Change From Baseline in eGFR to 4 Weeks Post-cessation of Randomized Treatment
Slope of eGFR Following the Initial Acute Effect of Randomized Treatment

Side effects data

From 2008 Phase 3 trial • 4128 Patients • NCT00095238
13%
CARDIAC FAILURE
13%
DIZZINESS
10%
OEDEMA PERIPHERAL
10%
HYPERTENSION
10%
HYPOTENSION
9%
DYSPNOEA
9%
BRONCHITIS
9%
NASOPHARYNGITIS
7%
CHEST PAIN
6%
HEADACHE
6%
DIARRHOEA
6%
INFLUENZA
6%
BACK PAIN
5%
ATRIAL FIBRILLATION
5%
ARTHRALGIA
5%
COUGH
5%
FATIGUE
4%
ANGINA UNSTABLE
4%
PNEUMONIA
3%
ANGINA PECTORIS
3%
CARDIAC FAILURE CONGESTIVE
3%
CEREBROVASCULAR ACCIDENT
3%
SUDDEN DEATH
2%
RENAL FAILURE
2%
MYOCARDIAL INFARCTION
2%
ACUTE MYOCARDIAL INFARCTION
2%
SYNCOPE
2%
ANAEMIA
2%
OSTEOARTHRITIS
1%
ARRHYTHMIA
1%
BRADYCARDIA
1%
ATRIAL FLUTTER
1%
MYOCARDIAL ISCHAEMIA
1%
ACUTE CORONARY SYNDROME
1%
CORONARY ARTERY DISEASE
1%
ATRIOVENTRICULAR BLOCK COMPLETE
1%
CHOLECYSTITIS
1%
CHOLELITHIASIS
1%
ISCHAEMIC STROKE
1%
TRANSIENT ISCHAEMIC ATTACK
1%
ABDOMINAL PAIN
1%
GASTROINTESTINAL HAEMORRHAGE
1%
CELLULITIS
1%
GASTROENTERITIS
1%
URINARY TRACT INFECTION
1%
RENAL FAILURE ACUTE
1%
DEHYDRATION
1%
HYPERKALAEMIA
1%
HYPOGLYCAEMIA
1%
DIABETES MELLITUS
1%
FALL
1%
HIP FRACTURE
1%
CARDIAC PACEMAKER MALFUNCTION
1%
PULMONARY OEDEMA
1%
PULMONARY EMBOLISM
1%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
1%
PROSTATE CANCER
1%
CATARACT
100%
80%
60%
40%
20%
0%
Study treatment Arm
IRBESARTAN
PLACEBO

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: sparsentan for double-blind and open-label extensionExperimental Treatment1 Intervention
Sparsentan will be administered as a single oral dose; an initial dose of 400 mg daily titrating up to a target dose of 800 mg, daily
Group II: IrbesartanActive Control1 Intervention
Irbesartan will be administered as a single oral dose; an initial dose of 150 mg daily titrating up to a target dose of 300 mg, daily

Find a Location

Who is running the clinical trial?

Travere Therapeutics, Inc.Lead Sponsor
22 Previous Clinical Trials
102,334 Total Patients Enrolled
Radko Komers, MD, PhDStudy DirectorTravere Therapeutics, Inc.
3 Previous Clinical Trials
521 Total Patients Enrolled
Priscila Preciado, MDStudy DirectorTravere Therapeutics, Inc.
2 Previous Clinical Trials
454 Total Patients Enrolled

Media Library

Irbesartan (Angiotensin Receptor Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT03493685 — Phase 3
Focal Segmental Glomerulosclerosis Research Study Groups: sparsentan for double-blind and open-label extension, Irbesartan
Focal Segmental Glomerulosclerosis Clinical Trial 2023: Irbesartan Highlights & Side Effects. Trial Name: NCT03493685 — Phase 3
Irbesartan (Angiotensin Receptor Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03493685 — Phase 3
~48 spots leftby Dec 2025
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