Chronic Kidney DiseasePhase 1/2BeeVenom-CKDNCT06901102
Effect of Bee Venom on Chronic Kidney Disease-Mineral Bone Disorders in Hemodialysis Patients: a Randomized Controlled Trial
A Phase 1/2 study testing Bee Venom Injection in people with Chronic Kidney Disease and Bee Venom, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Bee Venom, Hemodialysis
- What is being tested?
- Bee Venom Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2025to 20 Oct 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Islam M Aboalela, Nephrology Resident, M.B.B. Ch contact
Egypt1 site
Urology and Nephrology Center, Mansoura University
Al Mansurah, Dakahliya, 35111
Muhammed A Elhadedy, MD Nephrology, +201006545538, hadedy@mans.edu.eg
About this study
Official title: Bee Venom As Immunomodulator and Its Effect on Chronic Kidney Disease-Mineral Bone Disorders in Hemodialysis Patients: a Prospective Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Chronic Kidney Disease, Bee Venom, Hemodialysis
- Being tested
- Bee Venom Injection, Standard Care for CKD-MBD
- Keywords
- Bee venom, Mineral bone disorder, Hemodialysis, Immunomodulation, Regulatory T cells, Bone turnover markers
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bee Venom InjectionDrug
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-MBDDrug
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 group | Role | What they receive |
|---|---|---|
| Bee Venom Injection (Intervention Group) | Experimental | This group will receive bee venom injections to evaluate its effect on chronic kidney disease-related mineral bone disorder in hemodialysis patients. The bee venom will be administered subcutaneously, starting with a dose of 0.05 mL three times a week and escalating to 0.5 mL by week 5. The treatment will last for six months. Receives: Drug: Bee Venom Injection |
| Standard Care (Control Group) | Active comparator | This group will receive the usual clinical care for mineral bone disorders associated with chronic kidney disease in hemodialysis patients. Standard care may include phosphate binders, vitamin D receptor activators, and other treatments commonly used to manage MBD in CKD patients. Receives: Drug: Standard Care for CKD-MBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Bone-Specific Biomarkers (BALP, P1NP, TRAP-5b)
The primary outcome measure will evaluate the effect of bee venom injections on bone-specific biomarkers in hemodialysis patients with chronic kidney disease-mineral bone disorder (CKD-MBD). This will be assessed by measuring changes in bone-specific alkaline phosphatase (BALP), propeptides of type I procollagen (P1NP), and tartrate-resistant acid phosphatase (TRAP-5b) levels from baseline to the end of the study. The aim is to determine if bee venom therapy can improve bone turnover markers compared to standard care.
Measured: 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 (1)
Change in Bone Mineral Density (BMD) Measured by QCT of Lumbar Vertebrae
The secondary outcome measure will evaluate the effect of bee venom injections on bone mineral density (BMD) in hemodialysis patients with CKD-MBD, measured by quantitative computed tomography (QCT) of the lumbar vertebrae. Changes in both cortical and trabecular bone density will be assessed from baseline to the end of the study. This will help determine if bee venom therapy has a beneficial effect on improving bone density compared to standard care.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start10 Apr 2025 (estimated)
- Primary completion10 Oct 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mohammed Ahmed Aboalela, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901102
- Sponsor's protocol ID
- MS.24.12.3035
- Acronym
- BeeVenom-CKD
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, we have not yet determined whether individual participant data (IPD) will be shared with other researchers. After the study is completed, we will assess the feasibility and ethical considerations regarding data sharing. If IPD sharing becomes an option, appropriate measures will be taken to ensure participant confidentiality and compliance with data protection regulations.
Publications
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.
PubMed 31920363An 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.
PubMed 27618890Hwang 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.
PubMed 26131770Carpena 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.
PubMed 33142794
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bee Venom As Immunomodulator and Its Effect on Chronic Kidney Disease-Mineral Bone Disorders in Hemodialysis Patients: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06901102
- Acronym / sponsor ID
- BeeVenom-CKD / MS.24.12.3035
- Conditions
- Chronic Kidney Disease, Bee Venom, Hemodialysis
- Keywords
- Bee venom, Mineral bone disorder, Hemodialysis, Immunomodulation, Regulatory T cells, Bone turnover markers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bee Venom Injection (Intervention Group) | Experimental | Drug: Bee Venom InjectionThis group will receive bee venom injections to evaluate its effect on chronic kidney disease-related mineral bone disorder in hemodialysis patients. The bee venom will be administered subcutaneously, starting with a dose of 0.05 mL three times a week and escalating to 0.5 mL by week 5. The treatment will last for six months. |
| Standard Care (Control Group) | Active comparator | Drug: Standard Care for CKD-MBDThis group will receive the usual clinical care for mineral bone disorders associated with chronic kidney disease in hemodialysis patients. Standard care may include phosphate binders, vitamin D receptor activators, and other treatments commonly used to manage MBD in CKD patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bee Venom InjectionThis 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. | Drug | Bee Venom Injection (Intervention Group) |
| Standard Care for CKD-MBDThis 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. | Drug | Standard Care (Control Group) |
Primary outcome
Improvement in Bone-Specific Biomarkers (BALP, P1NP, TRAP-5b)
Time frame: 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.
The primary outcome measure will evaluate the effect of bee venom injections on bone-specific biomarkers in hemodialysis patients with chronic kidney disease-mineral bone disorder (CKD-MBD). This will be assessed by measuring changes in bone-specific alkaline phosphatase (BALP), propeptides of type I procollagen (P1NP), and tartrate-resistant acid phosphatase (TRAP-5b) levels from baseline to the end of the study. The aim is to determine if bee venom therapy can improve bone turnover markers compared to standard care.
1 secondary outcome
Change in Bone Mineral Density (BMD) Measured by QCT of Lumbar Vertebrae
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Background: PubMed 31920363Waziri 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.
- Background: PubMed 27618890An 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.
- Background: PubMed 26131770Hwang 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.
- Background: PubMed 33142794Carpena 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.
- Individual participant dataSharing planned: Undecided. At this stage, we have not yet determined whether individual participant data (IPD) will be shared with other researchers. After the study is completed, we will assess the feasibility and ethical considerations regarding data sharing. If IPD sharing becomes an option, appropriate measures will be taken to ensure participant confidentiality and compliance with data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Islam M Aboalela, Nephrology Resident, M.B.B. Ch contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bee Venom Injection in people with Chronic Kidney Disease and Bee Venom, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Islam M Aboalela, Nephrology Resident, M.B.B. Ch (+201023772520 ext. +20502364530, islammohameddd96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Bone-Specific Biomarkers (BALP, P1NP, TRAP-5b) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06901102, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.