Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis
NCT ID: NCT07219121
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
20 participants
INTERVENTIONAL
2025-10-07
2027-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Eligible participants with a kidney transplant receiving stable standard of care (SOC) therapy, including standard immunosuppressive therapy (IST) to prevent graft rejection, will be enrolled to receive sparsentan treatment for 36 weeks. Participants will remain on standard IST for the duration of the study and will stop RAASi prior to initiating sparsentan treatment. The final dose of a RAASi should be taken on the day before the Day 1 visit.
Participants with a kidney transplant, at least one year prior to screening, with biopsy-proven IgAN will take 200 mg orally once daily (QD) for 2 weeks, then 400 mg QD through Week 36. Participants with a kidney transplant with FSGS histological pattern in the graft, or a biopsy finding of both IgAN and glomeruli with FSGS patterns will take 400 mg orally QD for 2 weeks, then 800 mg QD through Week 36.
Study visits will be conducted at Day 5 and Weeks 2, 4, 6, 12, 24, and 36 following Day 1. Following the 36 week treatment period, all participants will complete a 4 week off-sparsentan treatment follow-up period (ie, no study drug), during which time treatment will be at the discretion of the investigator. Participants will have a telephone visit at Week 40.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Drug: Sparsentan
A non-immunosuppressive single molecule with dual antagonism of ETAR and AT1R, has shown potent anti-proteinuric effect in patients with native kidney disease, including IgAN and FSGS.
Sparsentan
For participants with a kidney transplant with IgAN:
Day 1 through Week 2 visit, participants will take 200 mg once daily (QD) prior to the morning meal. At the Week 2 visit, participants will titrate up to 400 mg QD and take this dose through Week 36, if tolerated and determined to be safe by the Investigator.
For participants with a kidney transplant with FSGS, or a biopsy finding of both IgAN and glomeruli with FSGS patterns:
Day 1 through Week 2 visit, participants will take 400 mg QD prior to the morning meal. At the Week 2 visit, participants will titrate up to 800 mg QD and take this dose through Week 36, if tolerated and determined to be safe by the Investigator.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sparsentan
For participants with a kidney transplant with IgAN:
Day 1 through Week 2 visit, participants will take 200 mg once daily (QD) prior to the morning meal. At the Week 2 visit, participants will titrate up to 400 mg QD and take this dose through Week 36, if tolerated and determined to be safe by the Investigator.
For participants with a kidney transplant with FSGS, or a biopsy finding of both IgAN and glomeruli with FSGS patterns:
Day 1 through Week 2 visit, participants will take 400 mg QD prior to the morning meal. At the Week 2 visit, participants will titrate up to 800 mg QD and take this dose through Week 36, if tolerated and determined to be safe by the Investigator.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male and female aged ≥18 years
* Participants with a kidney transplant with biopsy-proven IgAN or FSGS histological pattern in the graft.
* A period of ≥12 months since kidney transplantation.
* UPCR ≥0.5 g/g and eGFR (CKD-EPI creatinine-based formula ≥30 mL/min/1.73 m2.
* Participants who can become pregnant, must agree to the use of 1 highly reliable method of contraception from 7 days prior to the first dose of study intervention until 30 days after the last dose of study intervention.
* Systolic BP ≤160 mmHg and ≥100 mmHg, and diastolic BP ≤100 mmHg and ≥60 mmHg at screening.
* For participants on an ACEI and/or ARB, and/or sodium glucose cotransporter-2 (SGLT2) inhibitor, the dosing regimen(s) is stable for ≥6 weeks prior to screening.
Exclusion Criteria
* Immunosuppressive therapy (IST) regimen for kidney transplant or other systemic chronic ISTs including enteric budesonide that is not stable for \>6 weeks prior to Day 1. Exceptions include routine changes in the dose of CNIs to meet target level.
* \<3 months after antirejection treatment and active rejection.
* Active bacterial, fungal or viral infection and/or active treatment of infection including BK virus (BKV), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B and C \<3 months prior to and during the screening period.
* Current treatment for surgical complications.
* History of heart failure (New York Heart Association \[NYHA\] Class II-IV).
* Jaundice, hepatitis, or known hepatobiliary disease.
* Malignancy within the past 2 years with the exception of adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin, with no evidence or recurrence.
* History of alcohol or illicit drug use disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition).
* History of serious side effects or allergic response to any angiotensin II antagonist or ERA.
* Participant requires any of the prohibited concomitant medications.
* Treatment with sparsentan \<12 weeks prior to screening.
* Participant has participated in a study of another investigational product \<28 days prior to screening or plans to participate in such a study during the course of this study.
* Hematocrit \<27%, hemoglobin \<90 g/L (9 g/dL), or potassium \>5.5 mmol/L (5.5 mEq/L).
* The participant is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.
* The participant, in the opinion of the Investigator, is unable to adhere to the requirements of the study, including the ability to swallow the study IMP whole.
* The participant, in the opinion of the Investigator, has a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Travere Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Radko Komers, MD, PhD
Role: STUDY_DIRECTOR
Travere Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Cornell Medical Center
New York, New York, United States
University of North Carolina Chapel Hill
Mooresville, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Dallas Nephrology Associates
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TVTX-RE021-426
Identifier Type: -
Identifier Source: org_study_id