Charlotte Robinson

DocwireNews

In an abstract presented at the International Society of Nephrology World Congress of Nephrology 2024, Vlado Perkovic and others offered prespecified interim analysis (IA) results from APPLAUSE-IgAN, a phase 3 study evaluating the efficacy and safety of iptacopan versus placebo with optimized supportive therapy in patients with immunoglobulin A nephropathy (IgAN).
Study participants were adults with biopsy-confirmed IgAN with proteinuria ≥1 g/g based on 24-hour urine protein-to-creatinine ratio (24h-UPCR) regardless of maximally tolerated renin-angiotensin system inhibitors (RASi) for ≥3 months, with or without sodium-glucose transport protein 2 inhibitors. Estimated glomerular filtration rate (eGFR) at baseline for the main population was ≥30 ml/min/1.73 m2. Researchers randomized patients 1:1 to receive iptacopan 200 mg or placebo twice daily for 24 months; subjects also remained on supportive therapy.
The prespecified IA occurred when the first 250 patients reached month (M) 9 or discontinued the study. The primary objective was to show superiority of iptacopan versus placebo in reducing proteinuria at M9 by measuring log-transformed ratio to baseline in 24h-UPCR. Researchers also assessed the effect on proteinuria from first morning void (FMV).
In the iptacopan versus placebo groups, median (IQR) 24h-UPCR was 1.8 (1.4-2.7) versus 1.9 (1.5-2.8) g/g, and mean (SD) eGFR was 62.7 (26.0) versus 65.5 (26.7) mL/min/1.73m2. All but two patients in the placebo group received maximally approved and/or tolerated RASi doses. By the data cutoff, fewer patients had discontinued iptacopan (16.0%) than placebo (28.0%) and fewer reached the composite kidney failure end point (6.4% vs 13.6%; per protocol).
Iptacopan proved superior to placebo in reducing proteinuria (24h-UPCR) from baseline at M9, with a reduction of 38.3% (95% CI, 26.0%-48.6%; one-sided P&lt;.0001) versus placebo. The reduction in UPCR-FMV from baseline at M9 with iptacopan versus placebo was 35.8% (95% CI, 22.6%-46.7%).
Results confirmed that iptacopan is superior to placebo in reducing proteinuria at M9, and it is well-tolerated with a favorable safety profile.
Source: <a href="https://doi.org/10.1016/j.ekir.2024.02.1414" target="_blank" rel="noopener">KI Reports</a>

Emily Menendez

Non-Invasive NETseq Classifier Determines NET Diagnosis With High Accuracy, Sensitivity

GEP-NETs

High Tumor Mutational Burden Linked to Worse OS, RFS in Patients with HCC

Hepatocellular Carcinoma

Cecilia Brown

IASLC and LCRF Award Team Science Grant for Work on Immune-Based Approaches to Target Drug-Resistant Lung Cancer Cells

Lung Cancer

Latest News

Iptacopan Demonstrates Potential for IgAN

WCN 2024

Interim analysis from the APPLAUSE-IgAN trial found favorable results for the use of iptacopan in immunoglobulin A nephropathy (IgAN).

Iptacopan Demonstrates Potential for IgAN 

About Us

Editorial Policy

Advertising

eNewsletters

Contribute

Contact Us

MashupMD

Blood Cancers Today

Cancer Nursing Today

GU Oncology Now

Urban Health Today

Bile Duct Cancer

Colorectal Cancer

Gastroesophageal Cancer

Gastric Cancer

GIST

Liver Cancer

Pancreatic Cancer

GI Oncology Now

Anemia

Deep Vein Thrombosis

Essential Thrombocythemia

Hemophilia

Immune Thrombocytopenic Purpura

Myelodysplastic Syndromes

Myelofibrosis

Myeloproliferative Neoplasms

Polycythemia Vera

Pulmonary Embolism

Sickle Cell Disease

Thrombocytopenia

Thrombophilia

Thrombosis

Thrombotic Thrombocytopenic Purpura

Venous Thromboembolism

von Willebrand Disease

Heme Today

Acute Kidney Injury

ADPKD

Anemia and Kidney Disease

Chronic Kidney Disease

COVID-19 and Kidney Disease

Diabetes and Hypertension

End-Stage Renal Disease

Gout

Hyperkalemia

IgAN

Kidney Transplantation

Metabolic Acidosis

Nephrology Times

Mesothelioma

Non-Small Cell Lung Cancer

Small Cell Lung Cancer

Squamous Cell Lung Carcinoma

Lung Cancers Today

Atherosclerotic Disease

Atrial Fibrillation

Heart Failure

Hypertension

Interventional Cardiology

Lipid Management

Practice Tips With Dr. Lichaa

Preventive Cardiology

Stroke

Cardiology

Breast Cancer

Gynecologic Cancer

Head and Neck Cancer

Skin Cancer

Oncology

Sleep

Diabetes

Ophthalmology

— Demodex Blepharitis

Neurology

Rheumatology

Gastroenterology

Pulmonology

Infectious Diseases

— HIV

Health and Wellness

Lupus

Future of Medicine

Orthopedics

Pharmacology

Career News

More

Conferences

CardioNerds

The Sleep Source With Dr. Morse

The Oncology Brothers

Rheumatology Rounds With Dr. Maheswaranathan

Healthcare Unfiltered

The Fellow on Call

Partners

Hurricanes & Health Care

Career Center

Expert Interviews

Subscribe