At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Sparsentan (drug), Sparsentan (drug), Sparsentan (drug)
- How long the study runs
- Study runs about 68 months (dates as stated)
- About the drug or intervention
- Sparsentan — drug: Population 1: 800 mg Sparsentan (oral suspension) · Sparsentan — drug: Population 2: 400 mg Sparsentan (oral suspension) · Sparsentan — drug: Population 3: 400 mg Sparsentan (tablets)
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at whether a medicine called sparsentan can help children and teenagers with kidney conditions that cause protein to leak into their urine (proteinuria). It covers several kidney diseases: focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), immunoglobulin A nephropathy (IgAN), IgA vasculitis and Alport syndrome. The study is funded by Travere Therapeutics, Inc.
Who can take part
- Children under 18, with different minimum ages for each group: at least 1 year for FSGS or MCD, at least 2 years for IgAN, IgA vasculitis or Alport syndrome, and at least 8 years (and weighing at least 40 kg) for one IgAN group
- Kidneys still working reasonably well, based on a blood test called eGFR (estimated glomerular filtration rate) of 30 or above
- Blood pressure within a normal range for the child's sex and height
- A certain level of protein in the urine, which differs by group: highest for FSGS/MCD, lower for IgAN/IgA vasculitis/Alport syndrome, and in between for the older IgAN group
- For most groups, the diagnosis confirmed by a kidney biopsy (a small sample of kidney tissue) or, in some cases, by genetic testing
- For the older IgAN group: already taking certain blood-pressure-type medicines (ACE inhibitors or ARBs) for at least 12 weeks before screening
Who may not be able to
- Weighing less than 7.3 kg
- Kidney disease caused by infections, medicines or cancer, or IgA deposits caused by another condition
- A recent flare-up or new treatment (such as steroids or other immunosuppressive medicines) within 6 months before screening, or immunosuppressive medicines not on a steady dose for at least 1 month
- Certain heart problems, including heart failure or significant heart valve disease
- Liver problems such as jaundice or hepatitis, or certain high liver blood test results
- Cancer within the past 2 years
- Certain blood test results that are too low (haemoglobin or haematocrit) or too high (potassium)
- Allergy to sparsentan or similar medicines
- Pregnancy, breastfeeding, or (for girls who can become pregnant) not agreeing to use reliable contraception during the study
- An organ transplant (except corneal transplants), or having taken sparsentan before
- Taking part in another medicine study within 28 days before screening, or planning to during this study
- For the older IgAN group: being unable to swallow tablets whole
What taking part involves
- • Taking the study medicine sparsentan — how it is taken and the dose is not stated — ask the trial team
- • For the older IgAN group, continuing existing ACE inhibitor (ACEI) or ARB treatment
Time commitment: Not stated — ask the trial team about how long the study lasts, how many visits are needed, and what tests or procedures are involved.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 1 Year to 17 Years
- Who
- All
- Number of participants
- 67
- Started
- 2021-08-12
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for focal segmental glomerulosclerosis
- • Phase2 - 67 participants
- • To evaluate the safety, efficacy and tolerability of sparsentan oral suspension and tablets, and assess changes in proteinuria after once-daily dosing over 108 weeks
Who can take part?
- • Ages 1 Year to 17 Years
- • Diagnosed with focal segmental glomerulosclerosis
Where?
- • Bristol - University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital for Children
- • Glasgow - NHS Greater Glasgow and Clyde, Royal Hospital for Children
- • Liverpool - Alder Hey Children's NHS Foundation Trust
- • London - Great Ormond Street Hospital for Children NHS Foundation Trust
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
To evaluate the safety, efficacy and tolerability of sparsentan oral suspension and tablets, and assess changes in proteinuria after once-daily dosing over 108 weeks.
More detail
This is a multicenter, open-label, 112-week study of sparsentan in approximately 67 pediatric subjects aged ≥1 year to \<18 years with selected proteinuric glomerular diseases, divided into 3 populations, defined as follows: * Population 1: Subjects with selected proteinuric glomerular diseases associated with Focal Segmental Glomerulosclerosis (FSGS) and Minimal Change Disease (MCD) histological patterns * Population 2: Subjects with kidney biopsy-confirmed immunoglobulin A nephropathy (IgAN), immunoglobulin A vasculitis (IgAV), or Alport syndrome (AS) * Population 3: Subjects with kidney biopsy-confirmed IgAN The study will evaluate long-term safety, tolerability, and efficacy with pharmacokinetic (PK) evaluations at Day 1 (Baseline), Day 2 (Visit 4), and Week 12 (Visit 9) in Population 1 and Population 2. In Population 3, PK values will be evaluated at Day 1 (Baseline) and at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96. For Population 1 and Population 2, subjects will be enrolled in 3 cohorts based on age ranges. For Population 3, subjects will be enrolled in one cohort. Study Enrollment: * Population 1: FSGS and/or MCD (30 subjects total) 1. Cohort 1 (6 subjects): ≥8 years to \<18 years 2. Cohort 2 (18 subjects): ≥3 years to \<8 years 3. Cohort 3 (6 subjects): ≥1 year to \<3 years * Population 2: IgAN, IgAV, or AS (27 subjects total) 1. Cohort 1 (9 subjects): ≥8 years to \<18 years 2. Cohort 2 (12 subjects): ≥5 years to \<8 years 3. Cohort 3 (6 subjects): ≥2 years to \<5 years * Population 3: IgAN (10 subjects total) 1. 10 subjects: ≥8 years to \<18 years
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 1 Year - 17 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ kidney biopsy
- ✓ any of the prohibited concomitant medications as defined in the study protocol
- ✓ to begin pregnancy testing and initiate contraceptive use
What the study is looking for
- ✓Inclusion Criteria for All Subjects (All Three Populations):
- ✓A subject must meet all of the following criteria to be eligible for participation in this study:
- ✓The subject has an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening.
- ✓The subject has a mean seated blood pressure between the 5th and 95th percentile for sex and height.
- ✓Inclusion Criteria for Population 1:
See the full criteria
Where Is This Study? (5 UK sites)
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital for Children
Bristol BS2 8BJ, United Kingdom
NHS Greater Glasgow and Clyde, Royal Hospital for Children
Glasgow G51 4TF, United Kingdom
Alder Hey Children's NHS Foundation Trust
Liverpool L12 2AP, United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
London WC1N3JH, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700Manchester University NHS Foundation Trust
Manchester M13 9WL, United Kingdom
How to Get in Touch
Travere Call Center
Sponsor contactCONTACT
