Not Yet RecruitingPhase 1/2

Effect of Bee Venom on Chronic Kidney Disease-Mineral Bone Disorders in Hemodialysis Patients: a Randomized Controlled Trial

Egypt60 participantsStarted 2025-04-10

Plain-language summary

This study aims to evaluate the effectiveness of bee venom injections as a treatment for chronic kidney disease (CKD)-mineral bone disorder (MBD) in patients undergoing hemodialysis. MBD is a common complication in CKD patients, leading to abnormal mineral metabolism, bone disease, and increased cardiovascular risks. Current treatments are often inadequate and can have significant side effects. In this study, we will compare the effects of bee venom injections with standard care treatments in hemodialysis patients. Bee venom is known for its potential anti-inflammatory and immunomodulatory properties, which may help improve mineral metabolism and bone health regulation in these patients. By stimulating regulatory T cells (Tregs) through bee venom, we aim to reduce inflammation and restore bone health. We hope to answer whether bee venom can effectively reduce mineral bone disorder markers (such as calcium, phosphorus, and parathyroid hormone levels) and improve bone density in hemodialysis patients. The results could lead to a new treatment option for CKD-MBD, improving patient outcomes and quality of life.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients of both sexes aged 18 years and older. * Patients undergoing maintenance hemodialysis three times weekly for at least six months. * Patients who are not scheduled for kidney transplantation within the next year. Exclusion Criteria: * Current pregnancy or lactation. * Medical history of chronic conditions such as liver disease, cancer, or autoimmune diseases. * Refusal to participate in the study. * Active chronic infections, including HIV, HCV, HBV, and tuberculosis. * Current use of medications affecting bone metabolism (e.g., calcitonin, denosumab, estrogen) within the last six months. * History of renal allograft failure within the past year.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improvement in Bone-Specific Biomarkers (BALP, P1NP, TRAP-5b)

Timeframe: 6 months The primary outcome will be assessed at baseline and after 6 months of treatment to evaluate the effect of bee venom on bone metabolism in CKD-MBD patients undergoing hemodialysis.

Trial details

NCT IDNCT06901102

SponsorMansoura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-10

Contact for this trial

Islam M Aboalela, Nephrology Resident, M.B.B. Ch

+201023772520 islammohameddd96@gmail.com

View on ClinicalTrials.gov More Chronic Kidney Disease trials