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CompletedNCT07907588Updated Oct 30, 2026

Effect of Bee Venom on T Regulatory Cells and Inflammation in Hemodialysis Patients: a Prospective Study Thesis

A Phase 1/2 interventional study of Bee Venom (BV) in Hemodialysis, Inflammation and Regulatory T Cell, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Mansoura University · Phase 1/2, Interventional, and Other

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Jun 2024, registered Oct 2026).
Updated Oct 30, 2026Newly registeredGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Chronic kidney disease (CKD) has emerged asa major cause of morbidity and mortality world-wide. Advanced CKD results in accelerated cardiovascular disease, cachexia,anemia, andnumerous other complicationswhich impair thequalityof life and shorten the life span in this population Our study aims to investigate the effect of Bee venom on T Regulatory Cells and inflammation in hemodialysis patients. This study will be carried out on (60) hemodialysis patients attending Urology and Nephrology center (Mansoura university).

A prospective randomized control study. Patients will be devided in to two groups A. study group (20 patients) will receive bee venom. B. control group (40 patients): will not receive bee venom. All patients will be maintained on their regular medications eg: erythropoietin, iron, multivitamins, antihypertensive agents, and phosphate binders if needed.

02

Conditions studied

  • Hemodialysis
  • Inflammation
  • Regulatory T Cell

Browse trials for

Keywords

  • hemodialysis
  • inflammation
  • T-Reg
  • Bee Venom
03

In context

Inflammation

3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 2,577 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients of both sexes ≥18 years old.
  • Patients who are maintained on chronic hemodialysis thrice weekly for at least six months.

Exclusion criteria

Exclusion Criteria:

  • Patients with , infectious or neoplastic diseases, or .
  • Patients prepared for Kidney transplantation current year.
  • Patients with known allergy to bee venom.
  • Patients who are pregnant.
  • Refusal to participate in the study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Study arm

    Drug: Bee Venom (BV)

  • No intervention
    Control arm

Interventions

  • subcutaneous injection of Bee venom in the study group

06

What researchers measure

Primary outcomes

  1. measurement of the effect of bee venom on T-regulatory cells

    Time frame: 6 months

Secondary outcomes

  1. measurement of highly sensitive CRP

    Time frame: 6 months

07

Study locations

1 site
  • Urology and nephrology center, Mansoura University
    Al Mansurah, Dakahlia Governorate 35516, Egypt
08

References and documents

Publications

  • Choi SR, Lee YK, Cho AJ, Park HC, Han CH, Choi MJ, Koo JR, Yoon JW, Noh JW. Malnutrition, inflammation, progression of vascular calcification and survival: Inter-relationships in hemodialysis patients. PLoS One. 2019 May 2;14(5):e0216415. doi: 10.1371/journal.pone.0216415. eCollection 2019. PubMed 31048884 ↗
  • Caprara C, Corradi V, Scalzotto E, Frigo AC, Proglio M, Sharma R, Ronco C. Differential effects of peritoneal and hemodialysis on circulating regulatory T cells one month post initiation of renal replacement therapy. Clin Nephrol. 2021 Jan;95(1):37-44. doi: 10.5414/CN110158. PubMed 33074093 ↗
  • Campo S, Lacquaniti A, Trombetta D, Smeriglio A, Monardo P. Immune System Dysfunction and Inflammation in Hemodialysis Patients: Two Sides of the Same Coin. J Clin Med. 2022 Jun 28;11(13):3759. doi: 10.3390/jcm11133759. PubMed 35807042 ↗
  • An HJ, Kim KH, Lee WR, Kim JY, Lee SJ, Pak SC, Han SM, Park KK. Anti-fibrotic effect of natural toxin bee venom on animal model of unilateral ureteral obstruction. Toxins (Basel). 2015 May 29;7(6):1917-28. doi: 10.3390/toxins7061917. PubMed 26035488 ↗
  • Alvarenga L, Salarolli R, Cardozo LFMF, Santos RS, de Brito JS, Kemp JA, Reis D, de Paiva BR, Stenvinkel P, Lindholm B, Fouque D, Mafra D. Impact of curcumin supplementation on expression of inflammatory transcription factors in hemodialysis patients: A pilot randomized, double-blind, controlled study. Clin Nutr. 2020 Dec;39(12):3594-3600. doi: 10.1016/j.clnu.2020.03.007. Epub 2020 Mar 13. PubMed 32204978 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2024 to primary completion in Nov 2024, 5 months.

Of 40 non-industry phase 1/2 interventional studies under Inflammation, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 62. This study's 5 months is below that.

Counting every sponsor, half of 46 studies reached it within 29 months; a quarter within 13 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2026
First posted
Oct 30, 2026
StartActual
Jun 1, 2024
Primary completionActual
Nov 30, 2024
CompletionActual
Dec 30, 2024
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07907588
Responsible party
Rasha Kamal Ali Abouelenein (Specialist, Mansoura University) — Principal investigator
First posted
Oct 30, 2026
Start date
Jun 1, 2024
Primary completion
Nov 30, 2024
Completion
Dec 30, 2024
Last update
Oct 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Bee Venoms

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