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

NCT06901102 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-28

No results posted yet for this 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.

Conditions

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2025-10-10
Completion
2025-10-20

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06901102 on ClinicalTrials.gov