Tokyo, Oct. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063271) titled 'Association between baseline mean corpuscular volume and hemoglobin response after HIF-prolyl hydroxylase inhibitor initiation in maintenance hemodialysis patients' on Oct. 19.

Study Type: Observational

Primary Sponsor: Institute - Tojinkai Hospital

Condition: Condition - Renal anemia in maintenance hemodialysis patients Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate whether baseline mean corpuscular volume (MCV) is associated with the change in hemoglobin approximately 3 months after initiation of a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in maintenance hemodialysis patients. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Patients who meet all of the following criteria: 1. Patients receiving maintenance hemodialysis at dialysis facilities within Tojinkai. 2. Patients who newly initiated a HIF-PH inhibitor between October 26, 2020 and May 28, 2026. 3. Patients with baseline hemoglobin and MCV measured from the same blood sample within 30 days before HIF-PHI initiation. 4. Patients with a hemoglobin measurement available between days 60 and 120 after HIF-PHI initiation. 5. Patients with evidence of persistent HIF-PHI treatment through approximately 3 months. 6. Patients who received darbepoetin alone during the 28 days before HIF-PHI initiation. Key exclusion criteria - Patients meeting any of the following criteria will be excluded: 1. Baseline hemoglobin or MCV cannot be evaluated before HIF-PHI initiation. 2. No hemoglobin measurement is available between days 60 and 120 after HIF-PHI initiation. 3. Persistence of HIF-PHI treatment through approximately 3 months cannot be confirmed. 4. ESA treatment during the 28 days before HIF-PHI initiation was not darbepoetin alone, preventing uniform calculation of ERI for the primary analysis. 5. Patients who opt out of the use of their clinical information for this study. Target Size - 97

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2026 Year 10 Month 01 Day Date of IRB - 2026 Year 10 Month 08 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072304

Disclaimer: Curated by HT Syndication.