We conducted a multicenter, randomized, double-blind, placebo-controlled, phase IIb/III study (CASSIOPEIR) using a renal composite endpoint (i.e., doubling of SCr or end-stage renal disease) in seven Asian countries/region. CASSIOPEIR compared TRK-100STP (120 μg and 240 μg) with placebo in patients with non-diabetic CKD patients with primary glomerular disease or nephrosclerosis (n = 892). However, the superiority of TRK-100STP over placebo was not observed. A prior phase II study on which the Phase IIb/III study design was based included only Japanese patients. We therefore evaluated TRK-100STP efficacy and safety in a subgroup of Japanese patients using the CASSIOPEIR dataset. As the timing of treatment initiation is important in CKD, we conducted additional subgroup analyses based on the baseline serum creatinine (SCr) and eGFR. ITT analysis was performed in a Japanese subgroup (n = 339) in which the primary endpoint was the first occurrence of renal composite endpoint. Significant differences were observed for TRK-100STP 240 μg vs. placebo (P = 0.0493; HR 0.69 [95% CI: 0.47, 1.00]), but no significant difference was observed between TRK-100 120 μg and placebo (P = 0.3523; HR 0.85). More prominent improvement was observed with TRK-100STP 240 μg vs. placebo for baseline SCr < 3.0 mg/dL (P = 0.0031; HR 0.43); SCr < 3.5 mg/dL (P = 0.0237, HR 0.59); and eGFR ≥ 10 mL/min/1.73 m (P = 0.0339, HR0.67), respectively. No significant changes in urinary albumin/creatinine ratio and blood pressure were observed. TRK-100STP was generally well tolerated and most adverse drug reactions were mild or moderate in severity. In conclusion, in the Japanese subgroup of CASSIOPEIR, TRK-100STP 240 μg/day significantly improved the renal composite endpoint compared with placebo, with greater efficacy in subjects with SCr < 3.5 or eGFR ≥ 10 mL/min/1.73 m .
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http://dx.doi.org/10.1111/1744-9987.13616 | DOI Listing |
J Am Acad Orthop Surg Glob Res Rev
January 2025
Universidad Autónoma de Guadalajara, School of Medicine, Zapopan, Mexico.
Background: Physicians worldwide face the challenging task of improving patient satisfaction by reducing pain in injured patients. Currently, available therapeutic approaches provide only short-term relief of symptoms without addressing long-term satisfaction. This has led to exploring regenerative treatment options that can deliver better outcomes.
View Article and Find Full Text PDFJ Bone Joint Surg Am
January 2025
Northumbria Healthcare NHS Foundation Trust, Northumberland, United Kingdom.
Background: Greater trochanteric pain syndrome (GTPS) is a painful condition that can impair a patient's quality of life. If nonoperative measures fail, progressively more invasive treatment options may be required. This clinical trial aimed to evaluate the effectiveness of ultrasound-guided leukocyte-rich platelet-rich plasma (LR-PRP) injections in the treatment of refractory GTPS caused by bursitis and/or gluteal tendinopathy.
View Article and Find Full Text PDFDiabetes Care
January 2025
Division of Pediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway.
Objective: In the Diabetes Virus Detection and Intervention trial, antiviral treatment with pleconaril and ribavirin decreased the decline, compared with placebo, in endogenous C-peptide 1 year after diagnosis of type 1 diabetes (T1D) in children and adolescents. This article reports the results 2 and 3 years after diagnosis.
Research Design And Methods: This was a multicenter, randomized, placebo-controlled (1:1) trial of 96 children and adolescents aged 6-15.
Blood Transfus
December 2024
Department of Transfusion Medicine and Hematology, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano, Milan, Italy.
Background: Although topical corticosteroids (TCS) represent first-line treatment for vulvar lichen sclerosus (VLS) and as such should be prescribed to all women at time of diagnosis, approximately 30% of patients do not experience complete symptom resolution following such treatment. TCS may not effectively improve vulvar trophism and elasticity, both of which are crucial for sexual function. Owing to its regenerative and healing properties, cord blood platelet-rich plasma (CB-PRP) may represent an efficacious supplementary therapy, to be administered following first line treatment with TCS.
View Article and Find Full Text PDFJAMA Intern Med
January 2025
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Importance: The optimal antiviral drug for treatment of nonsevere influenza remains unclear.
Objective: To compare effects of antiviral drugs for treating nonsevere influenza.
Data Sources: MEDLINE, Embase, CENTRAL, CINAHL, Global Health, Epistemonikos, and ClinicalTrials.
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