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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6 to week 108
Awards & highlights

DUPLEX 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.Check my eligibility
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.See study design
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.

DUPLEX Trial Eligibility Criteria

Inclusion Criteria

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

DUPLEX Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients achieving a urine protein/creatinine (UP/C) ≤1.5 g/g and a >40% reduction
Slope of estimated glomerular filtration rate (eGFR)
Secondary outcome measures
Change in eGFR from baseline
Non-US countries: Percent change in eGFR
Slope of eGFR

Side effects data

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

DUPLEX 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 morning 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 morning 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
20 Previous Clinical Trials
177,265 Total Patients Enrolled
Priscila Preciado, MDStudy DirectorTravere Therapeutics, Inc.
2 Previous Clinical Trials
440 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

Frequently Asked Questions

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

Are there any short or long-term risks associated with sparsentan?

"There is clinical evidence to support the safety of sparsentan, as this drug has undergone Phase 3 trials."

Answered by AI

To whom is this trial available?

"This study is recruiting 371 patients with focal segmental glomerulosclerosis (FSGS) from around the world. Candidates must meet the following criteria: Be male or female, aged 8 to 75 years old (18 to 75 if outside of the US or UK), weigh at least 20 kg, have biopsy-proven FSGS lesions or documentation of a genetic mutation in a podocyte protein associated with FSGS, have urine protein/creatinine (UP/C) ≥1.5 g/g (170 mg/mmol), and have an eGFR ≥30 mL/min/1.73"

Answered by AI

Is this trial happening at a lot of different hospitals in Canada?

"To make travelling more convenient for potential participants, this trial is running at 79 sites. While some of these locations are in Upland, Sherman and Camp Hill, there are also other centres nearer to where you live."

Answered by AI

Could you please share what other scientific research has looked at sparsentan?

"sparsentan was first trialed in 2012 at BakerIDI Heart and Diabetes Institute. Out of the 48 total completed studies, 9 are still recruiting patients. The majority of these trials are based in Upland, Pennsylvania."

Answered by AI

Are there any available slots for participants in this research?

"Presently, this trial is not enrolling patients. It was last updated on October 27th, 2022 and was initially posted April 17th, 2018. If you are seeking other studies, there are 15 trials actively recruiting participants with focal segmental glomerulosclerosis (FSGS) and 9 for sparsentan."

Answered by AI

Are octogenarians being recruited for this experiment?

"Children as young as 8 and adults up to the age of 75 are eligible for this study, provided they meet the other inclusion criteria. There are 13 studies specifically designed for patients under 18 years old and 18 trials focused on those over 65."

Answered by AI

How many individuals are participating in this experiment?

"This particular trial is not currently looking for patients. However, if you're still interested in participating in a study, there are 15 other trials enrolling patients with focal segmental glomerulosclerosis and 9 studies involving sparsentan that are also seeking participants."

Answered by AI

What is sparsentan indicated to treat?

"Patients who have not adequately responded to monotherapy are often treated with sparsentan. Additionally, sparsentan may be effective for treating treatment-naive patients, those with hypertensive disease, and patients who are likely to require multiple antihypertensive drugs."

Answered by AI

What are the goals of this research?

"The primary outcome of this study, as defined by the sponsor Travere Therapeutics Inc., will be measured over a 36-week period and is slope of estimated glomerular filtration rate (eGFR). Additionally, this trial will secondary outcomes including Non-US countries: Percent change in eGFR at Week 108, Slope of eGFR from 6 weeks post randomization to Week 108, and Percentage Change in eGFR from 6 weeks post randomization to Week 108."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)
2018. "Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03493685.
~53 spots leftby Apr 2025
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