Clinical trial NCT06901102: Effect of Bee Venom on Chronic Kidney Disease-Mineral Bone Disorders in Hemodialysis Patients: a Randomized Controlled Trial
Official title: Bee Venom As Immunomodulator and Its Effect on Chronic Kidney Disease-Mineral Bone Disorders in Hemodialysis Patients: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Chronic Kidney Disease
Bee Venom
Hemodialysis
Keywords: Bee venom
Mineral bone disorder
Hemodialysis
Immunomodulation
Regulatory T cells
Bone turnover markers
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This prospective, randomized controlled trial investigates the potential therapeutic role of bee venom in improving mineral bone disorder (MBD) among hemodialysis patients with chronic kidney disease (CKD). MBD is a common complication in CKD, characterized by disruptions in calcium, phosphorus, parathyroid hormone (PTH), and vitamin D metabolism, leading to abnormal bone remodeling and an increased risk of fractures and cardiovascular events. Conventional treatments for MBD, including phosphate binders, vitamin D analogs, and calcimimetics, often fall short in achieving optimal biochemical control and carry significant side effects. Therefore, there is a need for innovative therapies.

Bee venom, derived from the sting of the honeybee (Apis mellifera), has shown immunomodulatory and anti-inflammatory properties, which may play a role in modulating immune responses and regulating mineral metabolism. Previous studies suggest that bee venom can influence T cell activity, particularly enhancing the function of regulatory T cells (Tregs), which are known to suppress inflammation and help maintain immune balance. Given that inflammation is a key driver in the pathogenesis of MBD, targeting the immune system through bee venom presents a novel approach to improving bone and mineral metabolism.

The study will involve 60 patients undergoing maintenance hemodialysis, randomly assigned to either the intervention group receiving bee venom injections or the control group receiving standard care. Bee venom will be administered subcutaneously, with a dose escalation schedule starting at 0.05 mL three times weekly in the first week and increasing to 0.5 mL three times weekly by week 5. The treatment will last for six months.

Clinical and laboratory evaluations will assess the effects of bee venom on key MBD biomarkers, including serum calcium, phosphorus, PTH levels, and bone turnover markers. Radiological assessments using quantitative computed tomography (QCT) will evaluate bone mineral density changes at the lumbar vertebrae. The study will also assess the safety profile of bee venom by monitoring adverse events and allergic reactions.

The primary goal is determining whether bee venom can significantly improve MBD markers compared to standard care. Secondary objectives include evaluating changes in bone mineral density, assessing the safety and tolerability of bee venom, and exploring potential effects on inflammation markers and cardiovascular risk factors. The findings from this study may provide insights into the possible role of bee venom as a therapeutic agent in managing CKD-MBD. They could lead to a new treatment option for hemodialysis patients.

Eligibility criteria: 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 outcomes:
measure: 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.
Secondary outcomes:
measure: Change in Bone Mineral Density (BMD) Measured by QCT of Lumbar Vertebrae
timeFrame: 6 months Bone mineral density measurements will be taken at baseline and at the end of the 6-month treatment period to assess the impact of bee venom on bone health in CKD-MBD patients undergoing hemodialysis.
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center, Mansoura University
state: Dakahliya
Study officials:
References:
citation: Waziri B, Duarte R, Naicker S. Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD): Current Perspectives. Int J Nephrol Renovasc Dis. 2019 Dec 24;12:263-276. doi: 10.2147/IJNRD.S191156. eCollection 2019.
citation: An HJ, Kim JY, Kim WH, Han SM, Park KK. The Protective Effect of Melittin on Renal Fibrosis in an Animal Model of Unilateral Ureteral Obstruction. Molecules. 2016 Aug 27;21(9):1137. doi: 10.3390/molecules21091137.
citation: Hwang DS, Kim SK, Bae H. Therapeutic Effects of Bee Venom on Immunological and Neurological Diseases. Toxins (Basel). 2015 Jun 29;7(7):2413-21. doi: 10.3390/toxins7072413.
citation: Carpena M, Nunez-Estevez B, Soria-Lopez A, Simal-Gandara J. Bee Venom: An Updating Review of Its Bioactive Molecules and Its Health Applications. Nutrients. 2020 Oct 31;12(11):3360. doi: 10.3390/nu12113360.