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NCT03762850 Clinical Trial

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

Immunoglobulin A Nephropathy Clinical Trial

— PROTECT  

Official title:
A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03762850
Other study ID # 021IGAN17001
Secondary ID 2017-004605-41
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 11, 2018
Est. completion date July 2026

Study information
Verified date February 2023
Source Travere Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the long-term (approximately 2 years) nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with immunoglobulin A nephropathy (IgAN).

Description:

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• sparsentan
Target dose of 400 mg daily
• irbesartan
Target dose of 300 mg daily
• Dapagliflozin
Target dose of 10 mg daily
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Sponsors (1)
Lead Sponsor Collaborator
Travere Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Croatia,  Czechia,  Estonia,  France,  Germany,  Hong Kong,  Italy,  Korea, Republic of,  Lithuania,  New Zealand,  Poland,  Portugal,  Spain,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Urine protein/creatinine ratio (UP/C) at Week 36 The primary efficacy endpoint is the change from baseline (Day 1) in the UP/C based on a 24-hour urine sample at Week 36. After the last patient randomized has undergone the Week 36 visit
Secondary eGFR over a 52-week period The rate of change in estimated glomerular filtration rate (eGFR) over a 52-week period following the initial acute effect of randomized therapy (the initial acute effect of randomized therapy is defined as the first 6 weeks of randomized treatment with study medication; thus, the analysis is from 6 weeks postrandomization to 58 weeks postrandomization eGFR chronic slope at 1 year.) Week 58 postrandomization
Secondary eGFR over a 104-week period The rate of change in estimated glomerular filtration rate (eGFR) over a 104-week period following initial acute effect of randomized therapy (the initial acute effect of randomized therapy is defined as the first 6 weeks of randomized treatment with study medication; thus, the analysis is from 6 weeks postrandomization to 110 weeks postrandomization eGFR chronic slope at 2 years.) Week 110 postrandomization
Secondary eGFR over a 110-week period The rate of change in eGFR over a 110-week (approximately 2 years) period following the initiation of randomized therapy (thus, the analysis is from Day 1 to 110 weeks postrandomization eGFR total slope at 2 years). Week 110 postrandomization
See also
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Enrolling by invitation NCT05132621 - The Genital Tract Microflora in Women With Systemic Lupus Erythematosus (SLE) and Immunoglobulin A (IgA) Nephropathy.
Recruiting NCT05856760 - A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN Phase 2
Recruiting NCT04662723 - Multicentre Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy. Phase 4
Recruiting NCT06291376 - Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN) Phase 3
Completed NCT02384317 - Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade Phase 2
Recruiting NCT05732402 - An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney Diseases Phase 1/Phase 2
Active, not recruiting NCT05248646 - Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN) Phase 3
Completed NCT01838239 - Development of a Metabolic Assessment Tool for Chronic Kidney Disease N/A
Recruiting NCT05852938 - A Study of BION-1301 in Adults With IgA Nephropathy Phase 3
Recruiting NCT05834738 - Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy Phase 2
Completed NCT04287985 - Safety and Efficacy Study of VIS649 for IgA Nephropathy Phase 2
Recruiting NCT05097989 - Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) Phase 2
Completed NCT05200871 - Humanistic Burden of (FSGS) Focal Segmental Glomerulosclerosis and IgAN (Immunoglobulin A Nephropathy)
Terminated NCT05162066 - Study to Evaluate the Safety, Tolerability of BCX9930 in Participants With Either Complement 3 Glomerulopathy (C3G), Immunoglobulin A Nephropathy (IgAN), or Primary Membranous Nephropathy (PMN) Phase 2
Active, not recruiting NCT04573920 - Atrasentan in Patients With Proteinuric Glomerular Diseases Phase 2
Withdrawn NCT02605525 - Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy Phase 2
Recruiting NCT04564339 - Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) Phase 2
Active, not recruiting NCT04573478 - Atrasentan in Patients With IgA Nephropathy Phase 3
Active, not recruiting NCT04663204 - A Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropathy Phase 2

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