Serum Kisspeptin levels in patients undergoing maintenance hemodialysis: a case-control study protocol.

BACKGROUND

Hypogonadism is a highly prevalent complication in patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis (MHD), leading to a significant reduction in quality of life. The underlying pathophysiology involving the Hypothalamic-Pituitary-Gonadal (HPG) axis is complex and not fully understood. Kisspeptin is the master upstream regulator of the HPG axis, but its status and role in uremic hypogonadism remain unclear. This study aims to investigate serum Kisspeptin levels in MHD patients and explore their relationship with the HPG axis.

METHODS

This single-center, observational, case-control study will be conducted at a university hospital in Shanghai. We will recruit approximately 78 patients with ESRD receiving stable MHD and 20 healthy volunteers as a control group. The primary outcome is the difference in serum Kisspeptin-54 levels between the two groups. Secondary outcomes include the correlation between Kisspeptin and other reproductive hormones (LH, FSH, testosterone, estradiol, and prolactin) and clinical symptoms of hypogonadism within the patient cohort. Blood samples will be collected pre-dialysis from patients and from controls in the morning. Serum Kisspeptin-54 will be measured by ELISA. The primary statistical analysis will be an Analysis of Covariance (ANCOVA) to compare Kisspeptin levels between groups, adjusting for age as a key confounder. DISCUSSION: This study is expected to clarify the status of circulating Kisspeptin in MHD patients. The findings may provide evidence for a state of central Kisspeptin resistance in uremia, offering new insights into the pathophysiology of uremic hypogonadism. Identifying Kisspeptin’s role could pave the way for novel diagnostic and therapeutic strategies for this common and debilitating condition. TRIAL REGISTRATION: This trial is registered with the Chinese Clinical Trial Registry (ChiCTR2500106627) (Registration Date 2025, Jul, 28th).