HemodialysisPhase 1/2NCT07907588
Effect of Bee Venom on T Regulatory Cells and Inflammation in Hemodialysis Patients: a Prospective Study Thesis
A Phase 1/2 study testing Bee Venom (BV) in people with Hemodialysis and Inflammation, run by Mansoura University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Inflammation, Regulatory T Cell
- What is being tested?
- Bee Venom (BV)
- 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
- 1 Jun 2024to 30 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 ≥18 years old.
- Patients who are maintained on chronic hemodialysis thrice weekly for at least six months.
Who cannot join
- Patients with autoimmune, infectious or neoplastic diseases, or HIV.
- Patients prepared for Kidney transplantation current year.
- Patients with known allergy to bee venom.
- Patients who are pregnant.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology and nephrology center, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
About this study
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.
- Conditions
- Hemodialysis, Inflammation, Regulatory T Cell
- Being tested
- Bee Venom (BV)
- Keywords
- hemodialysis, inflammation, T-Reg, Bee Venom
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bee Venom (BV)Drug
subcutaneous injection of Bee venom in the study group
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Active comparator | Not described Receives: Drug: Bee Venom (BV) |
| Control arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of the effect of bee venom on T-regulatory cells
Measured: 6 months
Secondary outcomes (1)
measurement of highly sensitive CRP
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Jun 2024
- Primary completion30 Nov 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Kamal Ali Abouelenein, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907588
- Sponsor's protocol ID
- MD.23.03.757.R1.R2
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31048884Caprara 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 33074093Campo 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 35807042An 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 26035488Alvarenga 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bee Venom on T Regulatory Cells and Inflammation in Hemodialysis Patients: a Prospective Study Thesis
- ClinicalTrials.gov ID
- NCT07907588
- Acronym / sponsor ID
- MD.23.03.757.R1.R2
- Conditions
- Hemodialysis, Inflammation, Regulatory T Cell
- Keywords
- hemodialysis, inflammation, T-Reg, Bee Venom
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 30 Oct 2026 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm | Active comparator | Drug: Bee Venom (BV) |
| Control arm | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of both sexes ≥18 years old.
- Patients who are maintained on chronic hemodialysis thrice weekly for at least six months.
Key exclusion criteria (5 listed)
- Patients with autoimmune, infectious or neoplastic diseases, or HIV.
- Patients prepared for Kidney transplantation current year.
- Patients with known allergy to bee venom.
- Patients who are pregnant.
- Refusal to participate in the study.
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 (BV)subcutaneous injection of Bee venom in the study group | Drug | Study arm |
Primary outcome
measurement of the effect of bee venom on T-regulatory cells
Time frame: 6 months
1 secondary outcome
measurement of highly sensitive CRP
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 31048884Choi 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.
- Background: PubMed 33074093Caprara 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.
- Background: PubMed 35807042Campo 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.
- Background: PubMed 26035488An 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.
- Background: PubMed 32204978Alvarenga 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (BV) in people with Hemodialysis and Inflammation, 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 30 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of the effect of bee venom on T-regulatory cells (time frame: 6 months). 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 NCT07907588, which also lists 5 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 30 Oct 2026.