Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT06901102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-28
First Post:
2025-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Bee Venom on Chronic Kidney Disease-Mineral Bone Disorders in Hemodialysis Patients: a Randomized Controlled Trial
Sponsor:
Mansoura University
Organization:
Study Overview
Official Title:
Bee Venom As Immunomodulator and Its Effect on Chronic Kidney Disease-Mineral Bone Disorders in Hemodialysis Patients: a Prospective Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BeeVenom-CKD
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: