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

NCT06901102 | Not Yet Recruiting Phase 1

• 1 other identifier: MS.24.12.3035
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Bee Venom; Hemodialysis

Keywords

Bee venom; Mineral bone disorder; Hemodialysis; Immunomodulation; Regulatory T cells; Bone turnover markers

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

Study Arms (2)

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.

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.

Drug: Standard Care for CKD-MBD

Interventions

Bee Venom Injection DRUG

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.

Bee Venom Injection (Intervention Group)

Standard Care for CKD-MBD DRUG

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.

Standard Care (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center, Mansoura University

Al Mansurah, Dakahliya, 35111, Egypt

Location

Related Publications (4)

• 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.

  PMID: 31920363 BACKGROUND

• 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.

  PMID: 27618890 BACKGROUND

• 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.

  PMID: 26131770 BACKGROUND

• 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.

  PMID: 33142794 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Bee Venoms; Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthropod Venoms; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

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

CONTACT

+201023772520; islammohameddd96@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrology Resident, Urology and Nephrology Center, Mansoura University

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 28, 2025
• Study Start: April 10, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 20, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

EG (1)