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Angiotensin II Receptor Blocker and Endothelin Receptor Antagonist
Sparsentan for IgA Nephropathy (SPARTACUS Trial)
Phase 2
Recruiting
Research Sponsored by Travere Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged ≥18 years at the time of signing the informed consent.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
SPARTACUS Trial Summary
This trial will study how a drug called sparsentan affects people with IgAN who are at risk of kidney failure. It will last 28 weeks.
Who is the study for?
Adults over 18 with IgA Nephropathy (IgAN), a kidney disease, can join this trial if they've had a biopsy confirming their condition. They must have been on stable doses of specific blood pressure medications (ACEI/ARB) and SGLT2 inhibitors for at least 12 weeks. Their urine test should show protein levels above a certain threshold, and their kidneys must be functioning above a set level. People who've had organ transplants (except corneal), severe heart or liver issues, secondary IgAN, or recent high-dose steroids cannot participate.Check my eligibility
What is being tested?
The study is testing the safety and effects of Sparsentan in combination with SGLT2 inhibitors in people with IgAN at risk of progressing to kidney failure despite current treatments. It's an open-label Phase 2 trial lasting for about half a year where all participants will receive the same treatment without any comparison group.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include those commonly associated with new medications such as headaches, nausea, high blood pressure changes due to Sparsentan's action on blood vessels, and possible interactions with existing medications.
SPARTACUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
SPARTACUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in urine albumin-creatinine ratio (UA/C) at Week 24
Secondary outcome measures
30% and 50% reduction from baseline in UA/C at Week 24
Blood pressure (BP) at each visit
Estimated glomerular filtration rate (eGFR) at each visit
+2 moreSPARTACUS Trial Design
1Treatment groups
Experimental Treatment
Group I: sparsentanExperimental Treatment1 Intervention
Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.
Find a Location
Who is running the clinical trial?
Travere Therapeutics, Inc.Lead Sponsor
20 Previous Clinical Trials
177,576 Total Patients Enrolled
Priscila Preciado, MDStudy DirectorTravere Therapeutics, Inc.
2 Previous Clinical Trials
751 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My IgA nephropathy is caused by another condition or I have IgA vasculitis.You have been diagnosed with IgA nephropathy through a biopsy in the past.I have not taken high doses of prednisone or any immunosuppressants in the last 12 weeks.I have been taking the same dose of an SGLT2 inhibitor for at least 12 weeks.I have been on a stable dose of heart medication for at least 12 weeks.I have not had any organ transplants except for a corneal transplant.I have a history of heart, liver, or significant cardiovascular disease.The amount of protein in your urine is higher than a certain level.Your eGFR kidney function test result is at least 25 mL/min/1.73m2.
Research Study Groups:
This trial has the following groups:- Group 1: sparsentan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has sparsentan obtained governmental authorization to be prescribed?
"Considering the absence of efficacy data and presence of safety data, sparsentan was assessed as a 2 on our team's rating scale from 1 to 3."
Answered by AI
Are there any remaining openings in this experiment that individuals can fill?
"As per the clinicaltrials.gov listing, recruitment for this particular study has ceased as of May 3rd 2023. There are still 48 other trials that are presently searching for candidates however."
Answered by AI
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