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Clinical Trials in Egypt / NCT06901102
Starting soon Phase 1/2

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

NCT06901102 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 1/2
Started
2025-04-10
Last updated
2025-03-28

Condition(s) studied

Chronic Kidney DiseaseBee VenomHemodialysis

Investigational drug(s) / intervention(s)

Bee Venom InjectionStandard Care for CKD-MBD

Bee Venom Injection: This intervention involves the administration of purified bee venom from Apis mellifera species (Abevac) via subcutaneous injections. The dosage starts at 0.05 mL three times a week and gradually escalates to 0.5 mL three times a week by week 5. The total duration of the treatment is 6 months. Bee venom is being evaluated for its potential immunomodulatory effects, including enhancing regulatory T cell function and improving mineral bone disorder (MBD) in patients undergoing hemodialysis.

Standard Care for CKD-MBD: This intervention represents the standard care for patients with chronic kidney disease-mineral bone disorder (CKD-MBD) undergoing hemodialysis. The treatment typically includes phosphate binders to control phosphorus levels, vitamin D receptor activators to regulate calcium and phosphorus metabolism, and calcimimetics to control parathyroid hormone (PTH) levels. The specific regimen may vary according to individual patient needs, but the control group will not receive bee venom injections as part of their therapy.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Urology and Nephrology Center, Mansoura University Al Mansurah Dakahliya

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06901102 on ClinicalTrials.gov ↗ ← All trials in Egypt