What is sparsentan studying for immunoglobulin A nephropathy (IgAN)?

Sparsentan is being studied to understand its safety and how it affects kidney function in patients with IgAN, including those newly diagnosed and those with recurrent disease after kidney transplantation. The research aims to evaluate sparsentan's potential to protect the kidneys over time. This study is sponsored by the University of Leicester.

Who may be eligible for this immunoglobulin A nephropathy clinical trial?

Adults aged 18 years and older with biopsy-confirmed IgAN may be eligible. Both newly diagnosed patients without recent ACEI or ARB therapy and patients with recurrent IgAN after kidney transplantation can participate. Participants must meet blood pressure requirements and not be pregnant or breastfeeding. Please review eligibility criteria for more details.

Is there any cost to participate in this immunoglobulin A nephropathy clinical trial?

Study-related care, including sparsentan and all trial visits, is provided at no cost. Personal expenses such as travel may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID04663204

Safety and Effectiveness of Sparsentan in Adults with New or Recurrent Immunoglobulin A Nephropathy

Led by University of Leicester · Updated on 2026-06-03

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and activity of sparsentan for treating adult patients with biopsy-confirmed immunoglobulin A nephropathy IgAN, including newly diagnosed patients who have not received prior ACEI or ARB therapy Cohort A and patients with recurrent IgAN after kidney transplantation Cohort B. This open-label, multi-center trial aims to explore sparsentans potential to protect kidney function over an extended period. In Cohort A, patients will start sparsentan at 200 mg daily, increasing to a target dose of 400 mg daily after two weeks if tolerated, with dose adjustments allowed to maintain the highest tolerable dose. Treatment will continue for 110 weeks, followed by a 4-week off-treatment follow-up. Cohort B patients will be randomly assigned to receive sparsentan plus standard care for 48 weeks or standard care alone for 24 weeks before adding sparsentan for the remaining 24 weeks, then followed by a 4-week follow-up. Additional antihypertensive treatments are allowed except for ACEIs, ARBs, aldosterone blockers, or aliskiren. Participants will undergo assessments including urine protein excretion, estimated and measured glomerular filtration rate GFR, kidney biopsy analysis using the Oxford Classification, MRI for kidney and heart function, bioimpedance for body water, and quality of life evaluations. Safety will be monitored through adverse events, lab tests, and vital signs. The primary outcome is urine proteincreatinine ratio at Week 36, with secondary outcomes assessing kidney function, proteinuria changes, and safety over up to 114 weeks.

CONDITIONS

Brief Title

A Study of the Safety and Activity of Sparsentan for the Treatment of Patients With Immunoglobulin A Nephropathy

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Willing and able to provide signed informed consent
Able to understand written and spoken English
Male or female aged 18 years or older
Diagnosed with biopsy-proven immunoglobulin A nephropathy within the last 6 months (Cohort A) or diagnosis of recurrent IgAN from kidney transplant biopsy within last 6 months (Cohort B)
Urine total protein value of at least 0.5 g/day (Cohort A) or UPCR at least 50 mg/mmol (Cohort B)
Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2 (Cohort A) or at least 25 mL/min/1.73 m2 (Cohort B)
No prior treatment with ACE inhibitors or angiotensin receptor blockers for IgAN within the last 12 months (Cohort A)
Stable standard of care immunosuppressive therapy including tacrolimus for kidney transplant patients (Cohort B)
Systolic blood pressure between 100 and 150 mmHg and diastolic blood pressure between 60 and 100 mmHg
Women of childbearing potential must agree to use highly reliable contraception methods from 7 days before first dose until 90 days after last dose
Negative pregnancy tests at screening visits for women of childbearing potential

You will not qualify if you...

IgAN secondary to other conditions such as systemic lupus erythematosus or liver cirrhosis
Rapidly progressive glomerulonephritis or rapid decline in kidney function
History of type 1 diabetes, uncontrolled type 2 diabetes, or high blood glucose at screening
Prior organ transplantation except corneal transplants
Use of prohibited medications including ACE inhibitors, ARBs, aldosterone blockers, or aliskiren
Recent or ongoing immunosuppressive treatment beyond allowed limits
History of heart failure or recent serious cardiovascular events
Significant liver disease or elevated liver enzymes
Recent malignancy except certain treated skin or cervical cancers
Low blood counts or high potassium levels at screening
History of alcohol or drug use disorder
Allergic reaction or hypersensitivity to sparsentan or similar drugs
Pregnancy, breastfeeding, or plans to become pregnant during the trial
Participation in another investigational drug trial within 28 days prior to screening
Any medical conditions or lab abnormalities that may interfere with safe participation or evaluation of sparsentan

Research Team

Justyna Szklarzewicz

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