Tokyo, Feb. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060675) titled 'Study on the relationship between blood zinc levels and the maintenance of kidney function' on Feb. 16.

Study Type: Observational

Primary Sponsor: Institute - Shimane University

Condition: Condition - Chronic Kidney Disease (CKD), Diabetic Kidney Disease (DKD), Hypertensive Nephrosclerosis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective of this study is to clarify the impact of serum zinc levels on the long-term decline rate (slope) of renal function (eGFR), its stability (coefficient of variation: CV), and renal hard outcomes. Specifically, we will verify the clinical validity of the pathomechanism "tubular cell repair failure due to zinc deficiency" suggested by our basic research. Furthermore, by comparing cohorts before and after the widespread use of SGLT2 inhibitors, we aim to evaluate whether serum zinc levels remain a useful biomarker for predicting renal functional stability under modern standard therapies. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who meet all of the following criteria: 1. Serum zinc levels were measured at the Department of Endocrinology and Metabolism between January 1, 2015, and December 31, 2023. 2. Follow-up eGFR data are available for at least 1.5 years after the date of the first serum zinc measurement (baseline). 3. eGFR was measured at least three times after the baseline date. Key exclusion criteria - Patients who meet any of the following criteria: 1. Receiving dialysis therapy (hemodialysis or peritoneal dialysis) or having undergone kidney transplantation at baseline. 2. Diagnosed with active malignancy at baseline (excluded from the primary analysis). 3. Received zinc supplementation (e.g., zinc acetate, polaprezinc) during the follow-up period (excluded from the primary analysis of natural clinical course). Target Size - 2400

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 01 Month 28 Day Date of IRB - 2026 Year 02 Month 09 Day Anticipated trial start date - 2026 Year 02 Month 10 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=R000069398

Disclaimer: Curated by HT Syndication.