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Immunoglobulin A NephropathyPhase 3PROTECTNCT03762850

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

A Phase 3 study testing sparsentan, irbesartan and Dapagliflozin in people with Immunoglobulin A Nephropathy, run by Travere Therapeutics, Inc. at 162 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Immunoglobulin A Nephropathy
What is being tested?
sparsentan, irbesartan and Dapagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
406 participants
Where
162 sitesin 18 countries
Study dates
11 Dec 2018to 19 Aug 2026
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older at screening
  • Biopsy-proven primary IgAN
  • Proteinuria of ≥1 g/day at screening
  • eGFR ≥30 mL/min/1.73 m2 at screening
  • Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (maximum tolerated dose and at least one-half of the maximum labeled dose)
  • Systolic BP ≤150 mmHg and diastolic BP ≤100 mmHg at screening
  • Willing to undergo change in ACEI and/or ARB and anti-hypertensive medications
  • Agree to contraception

Who cannot join

  • IgAN secondary to another condition
  • Presence of cellular glomerular crescents in >25% of glomeruli on renal biopsy (if biopsy available within 6 months of screening)
  • Chronic kidney disease (CKD) in addition to IgAN
  • History of organ transplantation, with exception of corneal transplants
  • Require any prohibited medications
  • Treatment of systemic immunosuppressive medications (including corticosteroids) for >2 weeks within 3 months of screening
Show all 35Show fewer
  • History of heart failure or previous hospitalization for heart failure or unexplained dyspnea, orthopnea, paroxysmal nocturnal dyspnea, ascites, and/or peripheral edema
  • Clinically significant cerebrovascular disease or coronary artery disease within 6 months of screening
  • Jaundice, hepatitis, or known hepatobiliary disease or elevations of transaminases (ALT/AST) >2 times upper limit of normal at screening
  • History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years
  • Hematocrit value <27% (0.27 V/V) or hemoglobin value <9 g/dL (90 g/L) at Screening
  • Potassium >5.5 mEq/L (5.5 mmol/L) at Screening
  • History of alcohol of illicit drug use disorder
  • History of serious side effect or allergic response to any angiotensin II antagonist or endothelin receptor antagonist, including sparsentan or irbesartan, or has a hypersensitivity to any of the excipients in the study medications
  • For female: Pregnancy, or planning to become pregnant during the course of the study, or breastfeeding
  • Participation in a study of another investigational product within 28 days of screening
  • Key Inclusion Criteria for the Open-Label Extension Period based on assessments at the Week 110 visit:
  • Completed participation in the double-blind period, including the Week 114 visit
  • Did not permanently discontinue study medication during the double-blind period
  • Agree to contraception
  • Key Exclusion Criteria for the Open-Label Extension Period based on assessments at the Week 110 and Week 114 visits:
  • Progression to end-stage renal disease (ESRD) requiring renal replacement therapy (RRT)
  • Development of any criteria for discontinuation of study medication or discontinuation from the study, between Week 110 and Week 114
  • Patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 110 and Week 114
  • eGFR ≤20 mL/min/1.73 m2 at Week 110
  • Female patient is pregnant or breastfeeding
  • Key Inclusion Criteria for the OLE Sparsentan + SGLT2 Inhibitor Sub study:
  • 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
  • A urine protein excretion value of ≥0.3 g/day.
  • An eGFR of ≥25 mL/min/1.73m2
  • On a stable dose of sparsentan for ≥8 weeks in the open-label extension period that is the maximum tolerated dose.
  • Key Exclusion Criteria for the OLE Sparsentan + SGLT2 Inhibitor Sub study:
  • Progressed to ESRD requiring RRT
  • Initiated or changed dose of a systemic immunosuppressive medication (including systemic steroids) within 12 weeks
  • Taking an SGLT2 inhibitor within 12 weeks

Trial locations and contacts

162 sites in 18 countries.

162 sites in 18 countries

United States40 sites
  • Travere Investigational Site

    Birmingham, Alabama, 35233

  • Travere Investigational Site

    Boston, Massachusetts, 02215

  • Travere Investigational Site

    Cleveland, Ohio, 44106

  • Travere Investigational Site

    Columbia, South Carolina, 29203

  • Travere Investigational Site

    Columbus, Ohio, 43210

  • Travere Investigational Site

    Coral Springs, Florida, 33071

  • Travere Investigational Site

    Denver, Colorado, 80230

  • Travere Investigational Site

    El Paso, Texas, 79935

  • Travere Investigational Site

    Fort Worth, Texas, 76104

  • Travere Investigational Site

    Fresh Meadows, New York, 11365

  • Travere Investigational Site

    Glendale, California, 91206

  • Travere Investigational Site

    Hinsdale, Illinois, 60521

  • Travere Investigational Site

    Hollywood, Florida, 33021

  • Travere Investigational Site

    Homewood, Alabama, 35209

  • Travere Investigational Site

    Houston, Texas, 77054

  • Travere Investigational Site

    Kansas City, Kansas, 66160

  • Travere Investigational Site

    Lawrenceville, Georgia, 30046

  • Travere Investigational Site

    Lewisville, Texas, 75057

  • Travere Investigational Site

    Louisville, Kentucky, 40202

  • Travere Investigational Site

    Marshfield, Wisconsin, 54449

  • Travere Investigational Site

    Miami, Florida, 33136

  • Travere Investigational Site

    Miami, Florida, 33186

  • Travere Investigational Site

    Minneapolis, Minnesota, 55404

  • Travere Investigational Site

    Montebello, California, 90640

  • Travere Investigational Site

    Muncie, Indiana, 47303

  • Travere Investigational Site

    Nampa, Idaho, 83687

  • Travere Investigational Site

    New York, New York, 10032

  • Travere Investigational Site

    Northridge, California, 91324

  • Travere Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Travere Investigational Site

    Reno, Nevada, 89511

  • Travere Investigational Site

    Salt Lake City, Utah, 84115

  • Travere Investigational Site

    Salt Lake City, Utah, 84132

  • Travere Investigational Site

    San Antonio, Texas, 78207

  • Travere Investigational Site

    San Diego, California, 92103-6204

  • Travere Investigational Site

    San Diego, California, 92103

  • Travere Investigational Site

    Springfield, Massachusetts, 01104

  • Travere Investigational Site

    Stanford, California, 94205

  • Travere Investigational Site

    Tacoma, Washington, 98405

  • Travere Investigational Site

    Winter Park, Florida, 32789

  • Travere Investigational Site

    Worcester, Massachusetts, 01608

Other trials in United States

United Kingdom20 sites
  • Travere Investigational Site

    Birmingham, West Midlands, B9 5SS

  • Travere Investigational Site

    Brighton, East Sussex, BN2 5BE

  • Travere Investigational Site

    Cambridge, Cambridgeshire, CB2 0QQ

  • Travere Investigational Site

    Cardiff, West Glamorgan, CF14 4XW

  • Travere Investigational Site

    Carshalton, Surrey, SM5 1AA

  • Travere Investigational Site

    Derby, Derbyshire, DE22 3DT

  • Travere Investigational Site

    Edinburgh, Scotland, EH16 4SA

  • Travere Investigational Site

    Glasgow, Strathclyde, G11 6NT

  • Travere Investigational Site

    Leicester, Leicestershire, LE5 4PW

  • Travere Investigational Site

    Liverpool, L9 7AL

  • Travere Investigational Site

    London, Greater London, E1 4AT

  • Travere Investigational Site

    London, Greater London, SE1 9RT

  • Travere Investigational Site

    London, E1 1FR

  • Travere Investigational Site

    London, SE5 9RS

  • Travere Investigational Site

    Manchester, Greater Manchester, M13 9WL

  • Travere Investigational Site

    Middlesbrough, Cleveland, TS4 3BW

  • Travere Investigational Site

    Preston, Lancashire, PR2 9HT

  • Travere Investigational Site

    Reading, Berkshire, RG1 5AN

  • Travere Investigational Site

    Salford, Greater Manchester, M6 8HD

  • Travere Investigational Site

    Stoke-on-Trent, Staffordshire, ST4 6QG

Other trials in United Kingdom

Spain13 sites
  • Travere Investigational Site

    Barcelona, 08003

  • Travere Investigational Site

    Barcelona, 08025

  • Travere Investigational Site

    Barcelona, 08035

  • Travere Investigational Site

    Barcelona, 08036

  • Travere Investigational Site

    Madrid, 28007

  • Travere Investigational Site

    Madrid, 28040

  • Travere Investigational Site

    Madrid, 28041

  • Travere Investigational Site

    Palma de Mallorca, Balearic Islands, 07120

  • Travere Investigational Site

    Sagunto, Valencia, 46520

  • Travere Investigational Site

    Seville, 41009

  • Travere Investigational Site

    Valencia, 46014

  • Travere Investigational Site

    Valencia, 46017

  • Travere Investigational Site

    Zaragoza, 50009

Other trials in Spain

Australia10 sites
  • Travere Investigational Site

    Adelaide, South Australia, 5000

  • Travere Investigational Site

    Birtinya, Queensland, 4575

  • Travere Investigational Site

    Concord, New South Wales, 2139

  • Travere Investigational Site

    Gosford, New South Wales, 2250

  • Travere Investigational Site

    Kingswood, New South Wales, 2747

  • Travere Investigational Site

    Nedlands, Western Australia, 6009

  • Travere Investigational Site

    New Lambton Heights, New South Wales, 2305

  • Travere Investigational Site

    Randwick, New South Wales, 2031

  • Travere Investigational Site

    Reservoir, Victoria, 3073

  • Travere Investigational Site

    St Leonards, New South Wales, 2065

Other trials in Australia

Germany10 sites
  • Travere Investigational Site

    Aachen, North Rhine-Westphalia, 52074

  • Travere Investigational Site

    Berlin, 10117

  • Travere Investigational Site

    Düsseldorf, North Rhine-Westphalia, 40210

  • Travere Investigational Site

    Hanover, Lower Saxony, 30625

  • Travere Investigational Site

    Jena, Thuringia, 07747

  • Travere Investigational Site

    Kaiserslautern, Rheinland Palatinate, 67655

  • Travere Investigational Site

    Kiel, Schleswig-Holstein, 23538

  • Travere Investigational Site

    Kiel, Schleswig-Holstein, 24105

  • Travere Investigational Site

    Trier, Rheinland Palatinate, 54292

  • Travere Investigational Site

    Villingen-Schwenningen, Baden-Wurttemberg, 78052

Other trials in Germany

Italy10 sites
  • Travere Investigational Site

    Bari, 70124

  • Travere Investigational Site

    Catania, 95123

  • Travere Investigational Site

    Catanzaro, 88100

  • Travere Investigational Site

    Lecco, 23900

  • Travere Investigational Site

    Milan, Lombardy, 20162

  • Travere Investigational Site

    Modena, 41124

  • Travere Investigational Site

    Pavia, 27100

  • Travere Investigational Site

    Ranica, Bergamo, 24020

  • Travere Investigational Site

    Roma, 00168

  • Travere Investigational Site

    Torino, 10126

Other trials in Italy

South Korea10 sites
  • Travere Investigational Site

    Anyang-si, 14068

  • Travere Investigational Site

    Busan, 47392

  • Travere Investigational Site

    Incheon, 21565

  • Travere Investigational Site

    Seongnam-si, Gyeonggi-do, 13620

  • Travere Investigational Site

    Seoul, 02841

  • Travere Investigational Site

    Seoul, 03080

  • Travere Investigational Site

    Seoul, 06273

  • Travere Investigational Site

    Seoul, 110-746

  • Travere Investigational Site

    Seoul, 120-752

  • Travere Investigational Site

    Seoul, 135-710

Other trials in South Korea

France8 sites
  • Travere Investigational Site

    Clermont-Ferrand, Puy De Dome, 63003

  • Travere Investigational Site

    Créteil, 94010

  • Travere Investigational Site

    Grenoble, Isere, 38043

  • Travere Investigational Site

    Marseille, Bouches-du-Rhone, 13005

  • Travere Investigational Site

    Montpellier, Herault, 34295

  • Travere Investigational Site

    Paris, Paris, 75015

  • Travere Investigational Site

    Paris, 75475

  • Travere Investigational Site

    Saint-Priest-en-Jarez, Pays de la Loire Region, 42270

Other trials in France

Belgium6 sites
  • Travere Investigational Site

    Bonheiden, 2820

  • Travere Investigational Site

    Bruges, 8310

  • Travere Investigational Site

    Ghent, 9000

  • Travere Investigational Site

    Kortrijk, 8500

  • Travere Investigational Site

    Liège, 4000

  • Travere Investigational Site

    Roeselare, 8800

Other trials in Belgium

Poland6 sites
  • Travere Investigational Site

    Krakow, 31-559

  • Travere Investigational Site

    Lodz, 93-347

  • Travere Investigational Site

    Olsztyn, 10-124

  • Travere Investigational Site

    Olsztyn, 10-561

  • Travere Investigational Site

    Warsaw, 04-749

  • Travere Investigational Site

    Wroclaw, 50-566

Other trials in Poland

Portugal6 sites
  • Travere Investigational Site

    Coimbra, 3000-075

  • Travere Investigational Site

    Lisbon, 1069-166

  • Travere Investigational Site

    Lisbon, 1649-035

  • Travere Investigational Site

    Loures, 2674-514

  • Travere Investigational Site

    Setúbal, 2910-446

  • Travere Investigational Site

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Hong Kong5 sites
  • Travere Investigational Site

    Hong Kong

  • Travere Investigational Site

    Kwun Tong, Kowloon

  • Travere Investigational Site

    Lai Chi Kok, Kowloon

  • Travere Investigational Site

    Shatin, New Territories

  • Travere Investigational Site

    Tsuen Wan, New Territories

Other trials in Hong Kong

Taiwan5 sites
  • Travere Investigational Site

    Hualien City, 970

  • Travere Investigational Site

    Kaohsiung City, 807

  • Travere Investigational Site

    Kaohsiung City, 81362

  • Travere Investigational Site

    New Taipei City, 220

  • Travere Investigational Site

    Taichung, 40705

Other trials in Taiwan

New Zealand4 sites
  • Travere Investigational Site

    Grafton, Auckland, 1142

  • Travere Investigational Site

    Hamilton, 3200

  • Travere Investigational Site

    Hastings, 4120

  • Travere Investigational Site

    New Plymouth, 4310

Other trials in New Zealand

Estonia3 sites
  • Travere Investigational Site

    Tallinn, 10617

  • Travere Investigational Site

    Tallinn, 13419

  • Travere Investigational Site

    Tartu, 50406

Other trials in Estonia

Croatia2 sites
  • Travere Investigational Site

    Osijek, 31000

  • Travere Investigational Site

    Zagreb, 10000

Other trials in Croatia

Czechia2 sites
  • Travere Investigational Site

    Prague, 10034

  • Travere Investigational Site

    Prague, 12808

Other trials in Czechia

Lithuania2 sites
  • Travere Investigational Site

    Kaunas, LT-50009

  • Travere Investigational Site

    Vilnius, LT-08661

Other trials in Lithuania

About this study

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

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).

Read the detailed description

This is a 114-week,randomized, multicenter, double-blind, parallel-group, active-control study with an open-label extension period of up to 156 weeks, for a total duration of up to 270 weeks in patients with IgAN who have persistent overt proteinuria and remain at high risk of disease progression despite being on a stable dose (or doses) of an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) that is (are) a maximum tolerated dose that is at least one half of the maximum labeled dose (MLD) (according to approved labeling. Approximately 380 patients aged ≥18 years will be enrolled in the study globally. The investigational drug (sparsentan) is a dual acting angiotensin receptor blocker and endothelin receptor antagonist. The active control is irbesartan.

The purpose of the study is to evaluate the potential benefit of sparsentan on kidney function by analyzing change in proteinuria (protein in urine) and estimated glomerular filtration rate (eGFR) as compared to current standard treatment.

Patients enrolled in the PROTECT study (Protocol 021IGAN17001) will be those at high risk of progressing to renal failure. They will be randomly assigned in a 1:1 ratio to either sparsentan or irbesartan, as the active control (current standard treatment) at the Day 1 (Randomization) visit. Study medication (sparsentan and irbesartan) will be administered as a single oral morning dose.

The primary analysis is change in proteinuria (urine protein/creatinine ratio) from baseline at Week 36 in sparsentan-treated patients as compared to irbesartan-treated patients.

Primary completion date represents the anticipated completion date of the double-blind portion of the study. Study completion date represents the anticipated completion date of the open-label extension portion of the study.

Patients participating in the open-label extension period may be evaluated for eligibility to participate in a randomized, open-label, controlled Sub study evaluating the safety and efficacy of an SGLT2 inhibitor in addition to stable sparsentan treatment (OLE Sub study). The SGLT2 inhibitor, dapagliflozin will be provided as "study medication" for the OLE Sub study. Following completion of the visit 12 weeks after the OLE baseline visit, eligible patients may receive open-label dapagliflozin for at least 12 weeks but up to 24 additional weeks, or through the end of the open-label extension period, whichever is shortest. Approximately 60 patients from the open-label extension period will be enrolled into the OLE Sub study.

Being tested
sparsentan, irbesartan, Dapagliflozin
Medical subject headings
Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sparsentanDrug

    Also called RE-021

    Target dose of 400 mg daily

  • irbesartanDrug

    Also called Irbesartan Tablets USP

    Target dose of 300 mg daily

  • DapagliflozinDrug

    Target dose of 10 mg daily

Study groups in NCT03762850
Study groupRoleWhat they receive
sparsentanExperimentalDouble-blind: Sparsentan will be administered daily as a 200-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 200 mg after 2 weeks will increase their dose to 400- mg and continue treatment to Week 110.
Receives: Drug: sparsentan
irbesartanActive comparatorDouble-blind: Irbesartan will be administered daily as a 150-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg and continue treatment to Week 110.
Receives: Drug: irbesartan
dapagliflozin + sparsentan (Sub study)ExperimentalOLE Sub study: Dapagliflozin will be administered daily as a 5-mg oral tablet, in addition to 400-mg of Sparsentan, for a period of 12 weeks.
Receives: Drug: sparsentan; Drug: Dapagliflozin
sparsentan (Sub Study)ExperimentalOLE Sub study: Sparsentan will be administered daily as a dose of 400-mg for a period of 12 weeks.
Receives: Drug: sparsentan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36

    24-hour urine sample was collected for analysis of UP/C via a mixed-model repeated-measures (MMRM) analysis. Missing responses were imputed prior to analysis using multiple imputation. Change from Baseline during the double-blind period in UP/C on the log scale was the dependent variable. Log Baseline UP/C was included as a covariate along with fixed effects for randomized treatment, time (ie, nominal visit in weeks), randomized treatment-by-time interaction, and randomization strata with participants as random effect. Estimates in log scale were back transformed. Baseline was defined as the last non-missing observation on or prior to the start of the dosing. Using Rubin's approach, estimated treatment effects are combined across all imputations to obtain overall estimates.

    Measured: Baseline (Day 1) and at Week 36

Secondary outcomes (2)
  1. Total Slope of Estimated Glomerular Filtration Rate (eGFR) Over a 110-week Period

    The rate of change in eGFR from Day 1 to Week 110 (ie, over 110 weeks) was analyzed via a mixed-model random coefficients analysis. Missing responses were imputed prior to analysis using multiple imputation. Fixed effects for randomized treatment, Baseline eGFR, time (in weeks), randomized treatment-by-time interaction, and randomization strata were included. In addition, the model also included a random intercept and random slope for each participant. Using Rubin's approach, the estimated treatment effects are combined across all imputations to obtain the overall estimates.

    Measured: From Day 1 to Week 110

  2. Annualized Slope of eGFR Following the Initial Acute Effect of Randomized Treatment (Chronic Slope)

    The rate of change in eGFR from Week 6 to Week 110 (ie, over 104 weeks following the initial acute effect of randomized therapy) was analyzed via a mixed-model random coefficients analysis. Missing responses were imputed prior to analysis using multiple imputation. Fixed effects for randomized treatment, Baseline eGFR, time (in weeks), randomized treatment-by-time interaction, and randomization strata were included. In addition, the model also included a random intercept and random slope for each participant. Using Rubin's approach, the estimated treatment effects are combined across all imputations to obtain the overall estimates.

    Measured: From Week 6 to Week 110 post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2018
  2. Study start11 Dec 2018
  3. Primary completion7 Aug 2023
  4. Study completion19 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03762850
Sponsor's protocol ID
021IGAN17001
Other IDs
2023-505495-30-00, 2017-004605-41, 2017, 2023
Acronym
PROTECT
Status last verified
Sep 2026
First submitted
27 Nov 2018
Last updated
14 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Requests for clinical trial data, including language stating its intended use, should be directed to datarequest@travere.com. If approved, the requested information will be provided to the requestor after signing a data access agreement. Requests can be made following completion of the study and full publication of the study data in a peer reviewed journal for up to 36 months following its publication. Travere reserves the right to decline or recommend modifications to a request if it does not comply with the data sharing policy or if it is determined that the request is made by a biased source.

Publications

  • Heerspink HJL, Rovin BH, Komers R, Hendry B, Mercer A, Preciado P, Murphy E, Tesar V. Association between Complete Proteinuria Remission and Kidney Function in the Phase 3 PROTECT Trial of Sparsentan in IgA Nephropathy. Clin J Am Soc Nephrol. 2026 Apr 1;21(4):578-592. doi: 10.2215/CJN.0000000961. Epub 2025 Dec 22.

    PubMed 41428405
  • Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

    PubMed 38299639
  • Rovin BH, Barratt J, Heerspink HJL, Alpers CE, Bieler S, Chae DW, Diva UA, Floege J, Gesualdo L, Inrig JK, Kohan DE, Komers R, Kooienga LA, Lafayette R, Maes B, Malecki R, Mercer A, Noronha IL, Oh SW, Peh CA, Praga M, Preciado P, Radhakrishnan J, Rheault MN, Rote WE, Tang SCW, Tesar V, Trachtman H, Trimarchi H, Tumlin JA, Wong MG, Perkovic V; DUPRO steering committee and PROTECT Investigators. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial. Lancet. 2023 Dec 2;402(10417):2077-2090. doi: 10.1016/S0140-6736(23)02302-4. Epub 2023 Nov 3.

    PubMed 37931634
  • Obadina M, Wilson S, Derebail VK, Little J. Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations. Kidney360. 2023 Jul 1;4(7):997-1005. doi: 10.34067/KID.0000000000000162. Epub 2023 May 31.

    PubMed 37254256
  • Heerspink HJL, Radhakrishnan J, Alpers CE, Barratt J, Bieler S, Diva U, Inrig J, Komers R, Mercer A, Noronha IL, Rheault MN, Rote W, Rovin B, Trachtman H, Trimarchi H, Wong MG, Perkovic V; PROTECT Investigators. Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. Lancet. 2023 May 13;401(10388):1584-1594. doi: 10.1016/S0140-6736(23)00569-X. Epub 2023 Apr 1.

    PubMed 37015244

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