A Multicentered, Single-group Phase 2, Exploratory, Open-label Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in the Treatment of Adult Participants With IgAN

This is a 28-week, open-label, multicenter, single-group Phase 2 exploratory study to determine the safety and effect of sparsentan in participants with IgAN who are at risk of disease progression to kidney failure despite being on both stable RAASi and SGLT2 inhibitor treatment for at least 12 weeks prior to study entry

Start Date19 May 2023

Sponsor / Collaborator

Travere Therapeutics, Inc.

NCT05630612 / RecruitingPhase 2IIT

Effects of Simultaneous ETA & AT1 Receptor Antagonism on Endothelial Function & Vascular Stiffness in ANCA-associated Vasculitis (SPARsentan in VASCulitis - SPARVASC)

ANCA-associated vasculitis is an autoimmune disease that causes damage to blood vessels. This leads to organ damage with the number of organs affected and the severity of damage varying significantly between patients.
Vasculitis patients also have a very high risk of heart attacks and strokes, called cardiovascular disease. A chemical called 'endothelin', produced by the blood vessels, causes vessels to stiffen and raises blood pressure and this associates with cardiovascular risk.
The investigators have previously shown that by blocking the effects of endothelin you reduce vessel stiffness, lower blood pressure and improve vessel function. However, these studies only blocked endothelin for a few hours. Now, the investigators would like to see if it is possible to maintain these benefits by blocking endothelin for longer.
Sparsentan is a tablet that blocks endothelin and lowers blood pressure. The investigators plan to give sparsentan to patients with vasculitis for 6 weeks. To determine if any beneficial effects of sparsentan are due to blood pressure lowering the investigators will give another group of vasculitis patients a tablet called irbesartan which lowers blood pressure but does not block endothelin. The investigators will compare the results between the two groups.

Start Date08 Dec 2022

Sponsor / Collaborator

The University of Edinburgh

[+1]

EUCTR2021-000621-27-SE / Unknown statusPhase 2

A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK

Start Date07 Sep 2022

Sponsor / Collaborator

Travere Therapeutics, Inc.

100 Clinical Results associated with Sparsentan

100 Translational Medicine associated with Sparsentan

100 Patents (Medical) associated with Sparsentan

Literatures (Medical) associated with Sparsentan

01 Jan 2024·Journal of the American Society of Nephrology : JASN

Treatment of IgA Nephropathy: A Rapidly Evolving Field

Article

Author: Fervenza, Fernando C ; El Karoui, Khalil ; De Vriese, An S

The pivotal event in the pathophysiology of IgA nephropathy is the binding of circulating IgA-containing immune complexes to mesangial cells, with secondary glomerular and tubulointerstitial inflammation and fibrosis. The paramount difficulty in the management of IgA nephropathy is the heterogeneity in its clinical presentation and prognosis, requiring an individualized treatment approach. Goal-directed supportive care remains the bedrock of therapy for all patients, regardless of risk of progression. Sodium–glucose transporter 2 inhibitors and sparsentan should be integral to contemporary supportive care, particularly in patients with chronic kidney damage. Pending the development of reliable biomarkers, it remains a challenge to identify patients prone to progression due to active disease and most likely to derive a net benefit from immunosuppression. The use of clinical parameters, including the degree of proteinuria, the presence of persistent microscopic hematuria, and the rate of eGFR loss, combined with the mesangial hypercellularity, endocapillary hypercellularity, segmental glomerulosclerosis, tubular atrophy/interstitial fibrosis, crescents score, is currently the best approach. Systemic glucocorticoids are indicated in high-risk patients, but the beneficial effects wane after withdrawal and come at the price of substantial treatment-associated toxicity. Therapies with direct effect on disease pathogenesis are increasingly becoming available. While targeted-release budesonide has garnered the most attention, anti–B-cell strategies and selective complement inhibition will most likely prove their added value. We propose a comprehensive approach that tackles the different targets in the pathophysiology of IgA nephropathy according to their relevance in the individual patient.

01 Jan 2024·Nature reviews. Nephrology

Renoprotective effects of sparsentan: clinical trial evidence in IgA nephropathy and FSGS

Article

Author: Wang, Monica

01 Jan 2024·Revue medicale suisse

Article

Author: De Seigneux, Sophie ; Masson, Gregoire ; Jaques, David ; Nachit, Marine ; Haidar, Fadi ; Saudan, Patrick

Molecules such as sparsentan and budesonide look promising to treat proteinuric IGA nephropathy. SLGT2 inhibitors have a prominent place in nephroprotection and could be used in the treatment of acute kidney injury due to heart failure as well. High volume hemodiafiltration compared to hemodialysis improves survival in dialysis patients. Lessening dialysate temperature does not improve hemodynamic stability during the dialysis session. Sodium bicarbonate does not seem to protect renal function in renal transplant patients. SGLT2 inhibitors may have a beneficial effect in these patients in terms of nephroprotection.

119

News (Medical) associated with Sparsentan

28 May 2024

·www.fiercepharma.com

Novartis rides IgAN trioka to 2 trial wins in rare kidney diseases

Novartis is developing three drugs against the kidney disease IgAN. In recent days, the company shared updates on two of them. Novartis is eyeing an FDA filing for a second drug in immunoglobulin A nephropathy (IgAN), as the Swiss pharma goes all-in on the rare autoimmune kidney disease from three different angles. Novartis plans to submit atrasentan to the FDA by the end of June for a potential accelerated approval in IgAN based on positive data from the phase 3 ALIGN trial. In the study, atrasentan led to a significant 36.1% relative reduction in proteinuria compared with placebo after 36 weeks of treatment, according to results presented at the European Renal Association Congress. Atrasentan could be a potential competitor to Travere Therapeutics’ rival drug Filspari (sparsentan). But as analysts from William Blair and Leerink Partners suggested, the Novartis med does not seem to have the upper hand. An IgAN showdown Heading into atrasentan’s 36-week readout, investors were expecting to see at least a 40% placebo-adjusted urine protein reduction because of earlier readouts based on small patient populations and shorter treatment periods, Leerink analysts pointed out in a Monday note. The Novartis drug pulled off a 38.1% reduction in proteinuria, as measured by urine protein to creatinine ratio (UPCR), versus 3.1% for placebo. Both groups also received standard supportive care. By comparison, in the phase 3 PROTECT trial, Travere’s Filspari was associated with an average reduction in proteinuria of 49.8% after 36 weeks, compared with 15.1% for off-label irbesartan. This translates into a 41% relative reduction for Filspari. The two drugs’ trials enrolled roughly similar populations, with some slight differences such as baseline UPCR that are not likely to significantly change the outcome or interpretation of results, William Blair analysts wrote in a Tuesday note. However, a notable difference in the percentage of Asian patients might be a confounding factor for a cross-trial comparison, the team added. Despite the differences between the trials, atrasentan does not appear to be differentiated versus Filspari, Leerink’s analysts said. A recent Leerink survey suggested that doctors would split their use of Filspari and atrasentan equally. Travere’s Filspari may have two advantages. First of all, Filspari already boasts an accelerated approval in IgAN since February 2023, and Travere has already filed for a full approval with a target decision date in September. That gives Filspari a roughly two-year head start against Novartis’ atrasentan, the William Blair team noted. Secondly, Filspari could reduce the number of pills patients have to take, which is an important consideration for many with IgAN, Leerink analysts noted. Filspari is a dual endothelin angiotensin receptor antagonist, while atrasentan inhibits the endothelin A receptor alone. Filspari’s mechanism eliminates the need for an angiotensin receptor blocker such as irbesartan, which is part of the standard of care for IgAN. However, having separate pills allows doctors to adjust the dose of each therapy for a patient, the Leerink team added. In the end, “choosing between the two will likely come down to a case-by-case decision, as well as which therapy is covered by payers/has an easier path to authorization,” the Leerink analysts said. Filspari’s early launch has been progressing nicely, with about 2,000 patient start forms received by the end of March. The drug missed statistical significance on its confirmatory trial endpoint—change in estimated glomerular filtration rate (eGFR) slope, a measure of kidney function—in the PROTECT trial. But Travere believes the results observed in the study could convince the FDA and doctors of its benefits. The confirmatory evidence flop leaves a window open for Novartis’ atrasentan to potentially differentiate itself with an eGFR win. Atrasentan’s ALIGN study remains ongoing and blinded toward its final eGFR analysis, which is expected in 2026. Plus, Filspari is still only penetrating a very small corner of the IgAN at this stage, and there remains significant room for a competitor, Willima Blair analysts aid. IgAN troika Atrasentan, which Novartis believes carries blockbuster potential, is one of the three drugs that the company is advancing in IgAN. Fabhalta, an oral factor B inhibitor, recently showed a 38.3% relative proteinuria reduction versus placebo in the phase 3 APPLAUSE-IgAN trial. The drug got its initial FDA approval in December for paroxysmal nocturnal hemoglobinuria (PNH), and Novartis has filed the IgAN indication with a decision now under priority review. At the ERA Congress, Novartis also shared phase 3 results for Fabhalta in an ultra-rare kidney disease called C3 glomerulopathy. In the APPEAR-C3G study, patients who got Fabhalta achieved a 35.1% reduction in proteinuria compared with placebo after six months of treatment. Novartis plans to file for the indication based on that surrogate endpoint in the second half of this year. At this point, on the eGFR endpoint, Fabhalta showed a numerical improvement of 2.2mL/min/1.73m2. Novartis has estimated Fabhalta could reach over $3 billion in peak sales across PNH, IgAN and C3G. The IgAN candidates target the kidney disease differently, and their ultimate positioning, including sequencing or combinations, will partly be defined by the data they generate, Shreeram Aradhye, M.D., said in a January interview with Fierce Pharma. With Fabhalta, Novartis is targeting the alternative complement pathway. Overactivation of the pathway and deposition of the complement protein could cause kidney damage. So Fabhalta is intervening through that pathogenic mechanism of the injury, Aradhye explained. Atrasentan, by targeting the endothelin receptor, inhibits excess proliferation and inflammatory signaling in mesangial cells, which are involved in IgAN. The third agent, zigakibart, is a subcutaneous anti-APRIL antibody. Aradhye said the drug has the potential to be disease-modifying because it intervenes at an early stage when abnormal IgA is formed. Its phase 3 IgAN readout is expected in 2026, and Novartis also has blockbuster hopes for that drug.

Clinical ResultPhase 3Drug ApprovalAccelerated ApprovalPriority Review

28 May 2024

·www.fiercepharma.com

Japan's Asahi Kasei puts up $1.06B offer to buy out Tarpeyo maker Calliditas

An acceptance period for the offer is expected to commence on or around July 18 and expire around August 30. Bolstered by a full FDA approval for its primary immunoglobulin A nephropathy (IgAN) treatment Tarpeyo, Calliditas has earned the attention of Japanese chemical giant Asahi Kasei. Asahi has made a cash offer to acquire Sweden’s Calliditas in a deal worth 11.16 billion Swedish crowns ($1.06 billion), the companies announced Tuesday. The proposal has already won the blessing of three of the Swedish drugmaker’s biggest stakeholders—BVF Partners, Linc AB and Stiftelsen Industrifonden—plus “other large securityholders," Calliditas explained in a release. An acceptance period for the offer is expected to commence on or around July 18 and expire around August 30, the companies added. Asahi’s bid for Calliditas represents a 74% premium to the company’s closing U.S. share price of $22.42 on May 24. Calliditas lists on both the Nasdaq in New York and Nasdaq Stockholm. Calliditas’ board believes the acquisition will benefit the company thanks to Asahi’s existing marketed offerings and its know-how in rare disease drug development and commercialization. As part of a larger platform under Asahi, Calliditas hopes to accelerate its revenue growth and pipeline development, according to the board. Asahi, for its part, said it’s charting the buyout in an effort to expand its business into “immunology, transplantation and adjacent diseases,” with a particular focus on the U.S. market. The Japanese conglomerate added that Calliditas’ Tarpeyo will groove well with Asahi’s existing geographic and therapeutic footholds. Asahi Kasei is one of Japan’s top industrial companies, with operations across chemicals, electronics, pharmaceuticals, medical devices and more. Back in 2020, the conglomerate established a U.S. pharmaceutical business platform through its acquisition of Veloxis Pharmaceuticals. More recently, the company in 2022 said it would pay an undisclosed sum to acquire Bay Area biologics maker Bionova Scientific in order to branch out into the CDMO space. Altogether, Asahi’s goal for the buyout is threefold: To solidify its U.S. presence by expanding its in-house sales structure for renal and autoimmune diseases; to establish a presence in Europe, initially focused on R&D; and to expand the scope of its in-licensing and new drug development opportunities. Asahi's buyout offer comes about half a year after Calliditas upgraded its accelerated approval for Tarpeyo, which is now the first treatment with a full FDA nod to treat the chronic autoimmune kidney condition IgAN, also known as Berger’s disease. The expanded green light also gave a boost to Tarpeyo’s label, allowing the drug to treat all patients with IgAN, rather than just those at risk for rapid disease progression. Aside from the Asahi acquisition reveal, Calliditas on Tuesday also rolled out additional efficacy and real-world data analysis on Tarpeyo at the 61st meeting of the European Renal Association (ERA). Calliditas’ efficacy analysis showed that treatment with Tarpeyo over nine months was linked to greater eGFR benefit versus continuous treatment with sparsentan over two years. eGFR, or estimated glomerular filtration rate, is a common measure of kidney function.

Drug ApprovalAcquisitionClinical Result

28 May 2024

·www.prnewswire.com

Calliditas Therapeutics Presents Data at the 61st European Renal Association Congress

STOCKHOLM, May 28, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced the presentations of an additional efficacy analysis of Nefecon (TARPEYO® (budesonide) delayed release capsules)) as well as a real-world analysis of the use of systemic glucocorticoids (SGC) in IgA nephropathy (IgAN). These were presented at ERA 2024 virtually and in Stockholm on May 23 - 26, 2024. The presented efficacy analysis of Nefecon and sparsentan showed that treatment with Nefecon for 9 months was associated with estimated glomerular filtration rate (eGFR) benefit compared with continuous treatment with sparsentan. Additionally, the findings of a real-world analysis of challenges associated with the use of systemic glucocorticoids demonstrate significant side effects and costs for IgAN patients treated with systemic glucocorticoids (SGC), such as Prednisone and Prednisolone. "It was wonderful to participate in ERA 2024 and present data contributing to the discussion on the need for effective treatments in IgAN," said Richard Philipson, Chief Medical Officer of Calliditas, " We continue to gather evidence that highlights the importance of treating the underlying autoimmune pathogenesis associated with IgAN, and we believe TARPEYO, as the only approved immunomodulating therapy designed to target the production of Gd-IgA1, has the potential to become a cornerstone therapy in IgAN." Poster presentation details are below and will be available on the Presentations and Publications page on the Calliditas' corporate website following the meeting. Presentation Analyses: Title: "Matching-adjusted indirect comparison of eGFR in patients with immunoglobulin A nephropathy treated with Nefecon (TRF budesonide) or sparsentan" A matching-adjusted indirect comparison (MAIC) methodology is a widely accepted and relevant methodology for comparing treatments across trials in the absence of head-to-head comparisons. Here the effects of Nefecon, marketed as TARPEYO® and sparsentan, marketed as FILSPARI™, on kidney function deterioration in patients with IgAN were compared, as assessed by eGFR change from baseline at 9, 12 and 24 months. Results from the MAIC showed significantly favorable effects of Nefecon versus sparsentan on eGFR across all time points analyzed. Mean differences in the absolute change in eGFR of 5.68mL/min/1.73 m2 (95% credible interval [Crl] 3.14, 8.20; p<0.001), 3.48 mL/min/1.73 m2 (95% Crl 0.97, 5.97; p=0.006) and 3.28 mL/min/1.73 m2 (95% Crl 0.02, 6.51; p=0.048) were observed when comparing Nefecon with sparsentan at 9 months vs 36 weeks, 12 months vs 48 weeks, and 24 months vs 106 weeks, respectively. This efficacy analysis showed that treatment with Nefecon 16 mg/day for 9 months was associated with greater eGFR benefit compared with continuous treatment with sparsentan 400 mg/day over 2 years, with significant differences observed as early as 9 months after treatment initiation and sustained up to 2-years of follow-up. While the rigor of well-controlled head-to-head clinical trials cannot be replicated, MAIC is also a widely accepted and relevant methodology for comparing treatments across trials in the absence of head-to-head comparisons1,2, *. Title: "Real-world challenges associated with the use of systemic glucocorticoids in a US IgAN cohort" Per Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, patients at high risk of progressive chronic kidney disease despite maximal supportive care can be considered for a 6-month course of systemic glucocorticoids (SGC), although important risks of toxicity and contraindications must be considered. There is currently limited real-world evidence describing the impact of the use of SGC on treatment-emergent toxicity and healthcare resource utilization (HCRU) in patients with IgAN. Our findings demonstrate significant side effects and costs for IgAN patients treated with SGC compared with patients not treated with SGC. Increases in severe infection incidents, inpatient visits, emergency department admissions, and ambulatory visits, underscore the careful consideration of treatment-emergent toxicity prior to initiating SGC therapy in patients with IgAN. *The optimization strategy in NefIgArd (optimized RASi) differed from the optimization strategy in PROTECT (IR), and anchoring of the two trials at optimized RASi/IR might lead to biased results. However, we also evaluated an unanchored MAIC in a sensitivity analysis and found very similar results. The MAIC method can only adjust the relative effect estimates for any observed effect modifier available in the data, but it cannot adjust for unobserved or unobservable effect modifiers. A significant number of potential treatment effect modifiers were included in the present analysis: age, sex, race, baseline eGFR, UPCR, UACR, and urinary protein excretion. Indication TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. Important Safety Information Contraindications: TARPEYO is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions, including anaphylaxis, have occurred with other budesonide formulations. Warnings and Precautions Hypercorticism and adrenal axis suppression: When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. When discontinuing therapy or switching between corticosteroids, monitor for signs of adrenal axis suppression. Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure to oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B). Risks of immunosuppression: Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressive doses of corticosteroids. Avoid corticosteroid therapy in patients with active or quiescent tuberculosis infection; untreated fungal, bacterial, systemic viral, or parasitic infections, or ocular herpes simplex. Avoid exposure to active, easily transmitted infections (e.g., chicken pox, measles). Corticosteroid therapy may decrease the immune response to some vaccines. Other corticosteroid effects: TARPEYO is a systemically available corticosteroid and is expected to cause related adverse reactions. Monitor patients with hypertension, prediabetes, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where corticosteroids may have unwanted effects. Adverse reactions: In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO treated patients, and ≥2% higher than placebo) were peripheral edema (17%), hypertension (12%), muscle spasms (12%), acne (11%), headache (10%), upper respiratory tract infection (8%), face edema (8%), weight increased (7%), dyspepsia (7%), dermatitis (6%), arthralgia (6%), and white blood cell count increased (6%). Drug interactions: Budesonide is a substrate for CYP3A4. Avoid use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine. Avoid ingestion of grapefruit juice with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4 activity, can increase the systemic exposure to budesonide. Use in specific populations Pregnancy: The available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with IgAN. Infants exposed to in-utero corticosteroids, including budesonide, are at risk for hypoadrenalism. Please see Full Prescribing Information . About TARPEYO TARPEYO is an oral 4mg delayed release formulation of budesonide, designed to remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer's patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy. About Primary Immunoglobulin A Nephropathy Primary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger's Disease) is a rare, progressive, chronic autoimmune disease that attacks the kidneys and occurs when galactose deficient IgA1 is recognized by autoantibodies, creating IgA1 immune complexes that become deposited in the glomerular mesangium of the kidney. This deposition in the kidney can lead to progressive kidney damage and potentially a clinical course resulting in end- stage renal disease. IgAN most often develops between late teens and late 30s. For further information, please contact: Åsa Hillsten, Head of IR & Sustainability, Calliditas Tel.: +46 76 403 35 43, Email: [email protected] The information was sent for publication, through the agency of the contact persons set out above, on May 28, 2024, at 14.00 p.m. CET. This information was brought to you by Cision . The following files are available for download: SOURCE Calliditas Therapeutics

Clinical ResultImmunotherapyClinical StudyDrug Approval

100 Deals associated with Sparsentan

External Link

KEGG	Wiki	ATC	Drug Bank
D11776	-	-	DB12548

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Glomerulonephritis, IGA	US	Travere Therapeutics, Inc.	17 Feb 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glomerulosclerosis, Focal Segmental	Phase 3	US	Travere Therapeutics, Inc.	17 Apr 2018
Glomerulosclerosis, Focal Segmental	Phase 3	AR	Travere Therapeutics, Inc.	17 Apr 2018
Glomerulosclerosis, Focal Segmental	Phase 3	AU	Travere Therapeutics, Inc.	17 Apr 2018
Glomerulosclerosis, Focal Segmental	Phase 3	BE	Travere Therapeutics, Inc.	17 Apr 2018
Glomerulosclerosis, Focal Segmental	Phase 3	BR	Travere Therapeutics, Inc.	17 Apr 2018
Glomerulosclerosis, Focal Segmental	Phase 3	CA	Travere Therapeutics, Inc.	17 Apr 2018
Glomerulosclerosis, Focal Segmental	Phase 3	HR	Travere Therapeutics, Inc.	17 Apr 2018
Glomerulosclerosis, Focal Segmental	Phase 3	CZ	Travere Therapeutics, Inc.	17 Apr 2018
Glomerulosclerosis, Focal Segmental	Phase 3	DK	Travere Therapeutics, Inc.	17 Apr 2018
Glomerulosclerosis, Focal Segmental	Phase 3	EE	Travere Therapeutics, Inc.	17 Apr 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03493685 (CTgov)	Phase 3	Glomerulosclerosis, Focal Segmental	371	Irbesartan	bjpmwjtowv(tpijpzwrfc) = qchdroibgl grbtytnhve (gmnhcbnnko, nasmfeptqo - qabfludwus) View more	-	30 Apr 2024
PROTECT (GlobeNewswire) Manual	Phase 3	Glomerulonephritis, IGA	404	FILSPARI	sprewqnikl(hgwxgxurvl) = tgkpmfkdkl zaqkgtsyvq (ojadsfemop ) View more	Positive	21 Sep 2023
				Irbesartan	sprewqnikl(hgwxgxurvl) = venjsijegh zaqkgtsyvq (ojadsfemop ) View more
NCT03762850 (PROTECT, FDA) Manual	Phase 3	Glomerulonephritis, IGA	281	FILSPARI	olaplovzjf(zadnsaofpv) = jelykqlaad rydjtfnxcz (rtsoybmbte, -51 to -38)	Superior	17 Feb 2023
				Irbesartan	olaplovzjf(zadnsaofpv) = yopbajqtyz rydjtfnxcz (rtsoybmbte, -24 to -4)
ASN2022	Phase 2	Glomerulosclerosis, Focal Segmental	108	Sparsentan 200 mg/day	qtxaxkcbtj(kjukheyndv) = ocztpkuusl nrsqhzrzhj (xcxxtawhro, 34.3 - 71.4) View more	Positive	04 Nov 2022
				Sparsentan 400 mg/day	qtxaxkcbtj(kjukheyndv) = xejsmdfimx nrsqhzrzhj (xcxxtawhro, 34.3 - 71.4) View more
ASN2022	Phase 1	-	22	Sparsentan 800mg	ngiokcbwfc(bzkservwdu) = pantofzwvz mskbqcymwy (uvzucdimka ) View more	Positive	04 Nov 2022
				Dapagliflozin 10mg	ngiokcbwfc(bzkservwdu) = cwkcmpdhwz mskbqcymwy (uvzucdimka ) View more
MO261 (ERA2022)	Not Applicable	Glomerulonephritis, IGA	-	Sparsentan 900 ppm	qaazsjnadk(thdwtuhpza) = SP900 treatment resulted in a greater and more rapid reduction in ACR from baseline compared with either mice treated with C or LS30 during the first 4 weeks of treatment vzjccptdir (wuvlalxemn ) View more	Positive	03 May 2022
				Losartan 30 mg/kg
NCT03762850 (PROTECT, Corporate Publications) Manual	Phase 3	Glomerulonephritis, IGA	404	sparsentan	zinhbjofnc(qwvvspobuy) = ozakqfbolz yuvzhqbrby (mcnrelnyab )	Positive	16 Aug 2021
				Irbesartan	zinhbjofnc(qwvvspobuy) = bpivygnaqh yuvzhqbrby (mcnrelnyab )
NCT01613118 (CTgov)	Phase 2	Glomerulosclerosis, Focal Segmental	109	Irbesartan	ityzqctbar(qyrcqzaltr) = isfcrybvqc hxnaoncxbo (jmzzenwtgb, hgkidbkwnm - akwpwxjmam) View more	-	27 Jul 2021
NCT03493685 (DUPLEX, Corporate Publications) Manual	Phase 3	Proteinuria \| Glomerulosclerosis, Focal Segmental	371	Sparsentan	snbezmlzrm(hknseeokxe) = mjnidqpvep hlsctqascd (agqdqwvwhd )	Positive	02 Feb 2021
				Irbesartan	snbezmlzrm(hknseeokxe) = pwnaxddgar hlsctqascd (agqdqwvwhd )
ASN2020	Not Applicable	Glomerulosclerosis, Focal Segmental	108	Sparsentan	eewdrjogpd(unrvfaruho) = iczhbaovsh udppgdteey (ddpypsvevb )	Positive	19 Oct 2020

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