BridgeMD
Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)
EU CTIS ID: 2023-505495-30-00
What this study is testing
The efficacy objective of the study is to determine the effect of sparsentan on proteinuria and preservation of renal function, as compared to an angiotensin receptor blocker (ARB), in patients with immunoglobulin A nephropathy (IgAN). The safety objective of the study is to assess the safety and tolerability of sparsentan by double-blind monitoring of safety endpoints. The open-label objective of the study is to assess the long-term efficacy, safety, and tolerability of open-label treatment with sparsentan in patients with IgAN.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Double-Blind Period: Male or female, aged ≥18 years.
- Open-Label Extension Period: The patient did not permanently discontinue study medication during the double-blind period.
- Open-Label Extension Period: WOCBP, beginning at menarche, must agree to the use of 1 highly reliable (ie, can achieve a failure rate of <1% per year) method of contraception from 7 days prior to the first dose of study medication until 90 days after the last dose of study medication (including open-label sparsentan). One additional barrier method must also be used during sexual activity, such as a diaphragm or diaphragm with spermicide (preferred), or male partner's use of male condom or male condom with spermicide (preferred), from the Week 114 visit until 90 days after the last dose of study medication.
- Sparsentan + SGLT2 Inhibitor Sub-study: Based on assessments at a regularly scheduled open-label extension visit, a patient must meet all of the following criteria to be eligible for the Sub-study: The patient is participating in the open-label extension and is willing and able to provide signed informed consent for participation in the open-label extension period Sub-study.
- Sparsentan + SGLT2 Inhibitor Sub-study: The patient has a urine protein excretion value of ≥0.3 g/day.
- Sparsentan + SGLT2 Inhibitor Sub-study: The patient has an eGFR of ≥25 mL/min/1.73m2.
You likely can't join if
- Double-Blind Period: IgAN secondary to another condition.
- Double-Blind Period: History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years.
- Double-Blind Period: A screening hematocrit value <27% (0.27 Volume/Volume) or hemoglobin value <9 g/dL (90 g/L).
- Double-Blind Period: A screening potassium value of >5.5 mEq/L (5.5 mmol/L).
- Double-Blind Period: Female patient is pregnant, breastfeeding or planning to conceive during the study.
- Double-Blind Period: Participation in a study of another investigational product within 28 days prior to screening.
See the full eligibility criteria
Who can join
- Double-Blind Period: Male or female, aged ≥18 years.
- Open-Label Extension Period: The patient did not permanently discontinue study medication during the double-blind period.
- Open-Label Extension Period: WOCBP, beginning at menarche, must agree to the use of 1 highly reliable (ie, can achieve a failure rate of <1% per year) method of contraception from 7 days prior to the first dose of study medication until 90 days after the last dose of study medication (including open-label sparsentan). One additional barrier method must also be used during sexual activity, such as a diaphragm or diaphragm with spermicide (preferred), or male partner's use of male condom or male condom with spermicide (preferred), from the Week 114 visit until 90 days after the last dose of study medication.
- Sparsentan + SGLT2 Inhibitor Sub-study: Based on assessments at a regularly scheduled open-label extension visit, a patient must meet all of the following criteria to be eligible for the Sub-study: The patient is participating in the open-label extension and is willing and able to provide signed informed consent for participation in the open-label extension period Sub-study.
- Sparsentan + SGLT2 Inhibitor Sub-study: The patient has a urine protein excretion value of ≥0.3 g/day.
- Sparsentan + SGLT2 Inhibitor Sub-study: The patient has an eGFR of ≥25 mL/min/1.73m2.
- Sparsentan + SGLT2 Inhibitor Sub-study: The patient is on a stable dose of sparsentan for ≥8 weeks in the open-label extension period that is the maximum tolerated dose.
- Sparsentan + SGLT2 Inhibitor Sub-study: The patient has ≥12 weeks of the study remaining.
- Sparsentan + SGLT2 Inhibitor Sub-study: The patient fulfils local requirements, recommendations and does not have contraindications for on-label prescription of dapagliflozin.
- Double-Blind Period: Biopsy-proven IgAN.
- Double-Blind Period: Urine protein excretion value ≥1.0 g/day at screening.
- Double-Blind Period: eGFR value of ≥30 mL/min/1.73 m2 at screening.
- Double-Blind Period: The patient has been on a stable dose of ACEI and/or ARB therapy for at least 12 weeks prior to screening.
- Double-Blind Period: At screening, systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤100 mmHg.
- Double-Blind Period: Women of childbearing potential (WOCBP) must agree to the use of two forms of contraception.
- Open-Label Extension Period: Based on assessments at the Week 110 and Week 114 visit, a patient must meet all of the following criteria to be eligible for the open-label extension period. The patient completed participation in the double-blind period, including the Week 114 visit.
- Open-Label Extension Period: The patient is willing and able to provide signed informed consent for participation in the open-label extension period.
What rules you out
- Double-Blind Period: IgAN secondary to another condition.
- Double-Blind Period: History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years.
- Double-Blind Period: A screening hematocrit value <27% (0.27 Volume/Volume) or hemoglobin value <9 g/dL (90 g/L).
- Double-Blind Period: A screening potassium value of >5.5 mEq/L (5.5 mmol/L).
- Double-Blind Period: Female patient is pregnant, breastfeeding or planning to conceive during the study.
- Double-Blind Period: Participation in a study of another investigational product within 28 days prior to screening.
- Open-Label Extension Period: Based on assessments at the Week 110 and Week 114 visits, a patient who meets any of the following criteria will be excluded from the open-label extension period: The patient has progressed to end-stage renal disease (ESRD) requiring renal replacement therapy (RRT).
- Open-Label Extension Period: The patient developed any criteria for discontinuation of study medication or discontinuation from the study, respectively, between Week 110 and Week 114.
- Open-Label Extension Period: The patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 110 and Week 114.
- Open-Label Extension Period: The patient has an eGFR value of ≤20 mL/min/1.73 m2 at Week 110.
- Open-Label Extension Period: The patient has a potassium value of >5.5 mEq/L (5.5 mmol/L).
- Double-Blind Period: Cellular glomerular crescents present in >25% of glomeruli on renal biopsy within 6 months prior to screening.
- Open-Label Extension Period: The female patient is pregnant or is breastfeeding.
- Sparsentan + SGLT2 inhibitor Sub-study: Based on assessments at an open-label extension visit, a patient who meets any of the following criteria will be excluded from participation in the open-label extension period Sub-study: The patient has progressed to ESRD requiring RRT.
- Sparsentan + SGLT2 inhibitor Sub-study: The patient has initiated or changed dose of a systemic immunosuppressive medication (including systemic steroids) within 12 weeks.
- Sparsentan + SGLT2 inhibitor Sub-study: The patient has been taking an SGLT2 inhibitor within 12 weeks.
- Sparsentan + SGLT2 inhibitor Sub-study: The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the Sub-study.
- Double-Blind Period: The patient has a chronic kidney disease in addition to IgAN.
- Double-Blind Period: Any organ transplantation, with the exception of corneal transplants.
- Double-Blind Period: Treatment with any of the prohibited concomitant medications.
- Double-Blind Period: Treatment with any systemic immunosuppressive medications (including corticosteroids) for >2 weeks within 3 months prior to screening
- Double-Blind Period: Documented history of heart failure and/or previous hospitalization for heart failure or unexplained dyspnea, orthopnea, paroxysmal nocturnal dyspnea, ascites, and/or peripheral edema.
- Double-Blind Period: Clinically significant cerebrovascular disease and/or coronary artery disease.
- Double-Blind Period: Jaundice, hepatitis, or known hepatobiliary disease (excluding asymptomatic cholelithiasis), or transaminase levels >2 times the upper limit of the normal range at screening.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Hong Kong
- Taiwan
- New Zealand
- Korea, Republic of
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Hong Kong; Taiwan; New Zealand; Korea, Republic of; Australia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.