Chronic Kidney Disease Requiring Chronic DialysisPhase 1/2NCT04072341
Effects of Green Propolis Extract (EPP-AF) on Inflammation in Hemodialysis Patients.
A Phase 1/2 study testing Propolis Period (Green Propolis 250mg/day) in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
End-stage chronic kidney disease is associated with the condition of chronic inflammation. Patients on hemodialysis are known to be predisposed to several factors that predispose to inflammation: dialysis membranes, central venous catheters, oxidative stress, fluid overload, sodium overload, uraemic toxins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis
- What is being tested?
- Propolis Period (Green Propolis 250mg/day)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2019to 30 Jan 2020
- 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
- Age over 18 years;
- Male or female on hemodialysis for at least 1 month.
Who cannot join
- Pregnant Woman;
- Carriers of active neoplasms;
- Patients undergoing kidney transplantation during the study;
- Infection during the study;
- Patients who underwent parathyroidectomy during the study;
- Patient using immunosuppressive drugs;
- Allergy to propolis or any of its components;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Marcelo Augusto Duarte Silveira
Salvador, Estado de Bahia, 41820-340
About this study
Official title: Effects of Green Propolis Extract (EPP-AF) on Inflammation in Hemodialysis Patients: a Randomized Cross-over Trial.
End-stage chronic kidney disease is associated with the condition of chronic inflammation. Patients on hemodialysis are known to be predisposed to several factors that predispose to inflammation: dialysis membranes, central venous catheters, oxidative stress, fluid overload, sodium overload, uraemic toxins. Propolis, a natural resin produced by bees from plant materials, has anti-inflammatory, immunomodulatory, and anti-oxidant properties. The aim of this study was to evaluate the impact of Brazilian green propolis extract on inflammation in hemodialysis patients.
Read the detailed description
Randomized open-label cross-over trial to investigate impact of Brazilian green propolis extract on inflammation in hemodialysis patients.
- Being tested
- Propolis Period (Green Propolis 250mg/day), Control Period
- Keywords
- Inflammation, Propolis, High-sensitivity C-reactive protein, Hemodialysis
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propolis Period (Green Propolis 250mg/day)Drug
Also called Standard treatment for their comorbidities.
Randomized, cross-over, open-label. Patients will go through two 4 week periods with 1 week washout between them. During the intervention period will use 250mg of green Propolis per day. In the control period they will only follow standard treatment for their comorbidities.
Control PeriodOther
Also called Standard treatment for their comorbidities.
In the control period they will only follow standard treatment for their comorbidities.
| Study group | Role | What they receive |
|---|---|---|
| Propolis Period | Experimental | Hemodialysis patients will be under regular treatment of their comorbidities and using Propolis. Receives: Drug: Propolis Period (Green Propolis 250mg/day) |
| Control Period | Experimental | Hemodialysis patients will be under regular treatment of their comorbidities, but without using Propolis. Receives: Other: Control Period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum level of High-sensitivity C-reactive protein from baseline to end of study periods.
Change in high sensitivity C-reactive protein from baseline to end of study periods.
Measured: 8 weeks
Secondary outcomes (3)
Change in serum level of Interleukin-1 Beta from baseline to end of study periods.
Change in Interleukin-1 Beta from baseline to end of study periods.
Measured: 8 weeks
Changes in serum level of alanine aminotransferase, aspartate aminotransferase, amylase and creatine kinase during the study, from baseline to end of study periods.
To evaluate the safety of propolis use in hemodialysis patients. Measurement of changes in serum level of alanine aminotransferase, aspartate aminotransferase, amylase and creatine kinase during the study.
Measured: 8 weeks
Percentage of participants with adverse events during the study.
We will evaluate the presence or absence of symptoms related to the use of propolis through a questionnaire.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Aug 2019
- Primary completion15 Dec 2019
- Study completion30 Jan 2020
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 Chronic Kidney Disease Requiring Chronic DialysisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Sequential
- Model description
- Prospective, open-label, proof-of-concept, single-center. Each patient served as their own control.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sao Rafael, Alagoas State University of Health Science , Maceió , Brazil.
- Responsible party
- Principal investigator, Marcelo Augusto Duarte Silveira, University of Sao Paulo General Hospital
- Investigators
- Marcelo Silveira, MD, PhD, Principal investigator, Hospital São Rafael S.AFlávio Teles, MD, PhD, Principal investigator, Universidade Estadual de Ciências da Saúde de AlagoasRogério Passos, Principal investigator, Hospital São Rafael S.A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072341
- Sponsor's protocol ID
- Hospital São Rafael S.A
- Status last verified
- May 2022
- First submitted
- 26 Aug 2019
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teles F, da Silva TM, da Cruz Junior FP, Honorato VH, de Oliveira Costa H, Barbosa AP, de Oliveira SG, Porfirio Z, Liborio AB, Borges RL, Fanelli C. Brazilian red propolis attenuates hypertension and renal damage in 5/6 renal ablation model. PLoS One. 2015 Jan 21;10(1):e0116535. doi: 10.1371/journal.pone.0116535. eCollection 2015.
PubMed 25607548Dai L, Golembiewska E, Lindholm B, Stenvinkel P. End-Stage Renal Disease, Inflammation and Cardiovascular Outcomes. Contrib Nephrol. 2017;191:32-43. doi: 10.1159/000479254. Epub 2017 Sep 14.
PubMed 28910789Silveira MAD, Teles F, Berretta AA, Sanches TR, Rodrigues CE, Seguro AC, Andrade L. Effects of Brazilian green propolis on proteinuria and renal function in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled trial. BMC Nephrol. 2019 Apr 25;20(1):140. doi: 10.1186/s12882-019-1337-7.
PubMed 31023272Cobo G, Lindholm B, Stenvinkel P. Chronic inflammation in end-stage renal disease and dialysis. Nephrol Dial Transplant. 2018 Oct 1;33(suppl_3):iii35-iii40. doi: 10.1093/ndt/gfy175.
PubMed 30281126Duarte Silveira MA, Malta-Santos H, Reboucas-Silva J, Teles F, Batista Dos Santos Galvao E, Pinto de Souza S, Dantas Dutra FR, Dantas Gomes MM, Teixeira MB, Miranda Rebelo da Conceicao LF, Nascimento CS, Vasques Nonaka CK, Cezar RS, Pena Batista PB, Berretta AA, Borges VM, da Hora Passos R. Effects of Standardized Brazilian Green Propolis Extract (EPP-AF(R)) on Inflammation in Haemodialysis Patients: A Clinical Trial. Int J Nephrol. 2022 Nov 22;2022:1035475. doi: 10.1155/2022/1035475. eCollection 2022.
PubMed 36457860
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Green Propolis Extract (EPP-AF) on Inflammation in Hemodialysis Patients: a Randomized Cross-over Trial.
- ClinicalTrials.gov ID
- NCT04072341
- Acronym / sponsor ID
- Hospital São Rafael S.A
- Keywords
- Inflammation, Propolis, High-sensitivity C-reactive protein, Hemodialysis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Hospital Sao Rafael, Alagoas State University of Health Science , Maceió , Brazil.
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 28 Aug 2019 (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.
End-stage chronic kidney disease is associated with the condition of chronic inflammation. Patients on hemodialysis are known to be predisposed to several factors that predispose to inflammation: dialysis membranes, central venous catheters, oxidative stress, fluid overload, sodium overload, uraemic toxins. Propolis, a natural resin produced by bees from plant materials, has anti-inflammatory, immunomodulatory, and anti-oxidant properties. The aim of this study was to evaluate the impact of Brazilian green propolis extract on inflammation in hemodialysis patients.
Detailed description
Randomized open-label cross-over trial to investigate impact of Brazilian green propolis extract on inflammation in hemodialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open-label, proof-of-concept, single-center. Each patient served as their own control.
| Arm | Type | Receives |
|---|---|---|
| Propolis Period | Experimental | Drug: Propolis Period (Green Propolis 250mg/day)Hemodialysis patients will be under regular treatment of their comorbidities and using Propolis. |
| Control Period | Experimental | Other: Control PeriodHemodialysis patients will be under regular treatment of their comorbidities, but without using Propolis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 18 years;
- Male or female on hemodialysis for at least 1 month.
Key exclusion criteria (7 listed)
- Pregnant Woman;
- Carriers of active neoplasms;
- Patients undergoing kidney transplantation during the study;
- Infection during the study;
- Patients who underwent parathyroidectomy during 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 |
|---|---|---|
| Propolis Period (Green Propolis 250mg/day)Also: Standard treatment for their comorbidities.Randomized, cross-over, open-label. Patients will go through two 4 week periods with 1 week washout between them. During the intervention period will use 250mg of green Propolis per day. In the control period they will only follow standard treatment for their comorbidities. | Drug | Propolis Period |
| Control PeriodAlso: Standard treatment for their comorbidities.In the control period they will only follow standard treatment for their comorbidities. | Other | Control Period |
Primary outcome
Change in serum level of High-sensitivity C-reactive protein from baseline to end of study periods.
Time frame: 8 weeks
Change in high sensitivity C-reactive protein from baseline to end of study periods.
3 secondary outcomes
Change in serum level of Interleukin-1 Beta from baseline to end of study periods.
Time frame: 8 weeks
Changes in serum level of alanine aminotransferase, aspartate aminotransferase, amylase and creatine kinase during the study, from baseline to end of study periods.
Time frame: 8 weeks
Percentage of participants with adverse events during the study.
Time frame: 8 weeks
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 18 May 2022.
- Background: PubMed 25607548Teles F, da Silva TM, da Cruz Junior FP, Honorato VH, de Oliveira Costa H, Barbosa AP, de Oliveira SG, Porfirio Z, Liborio AB, Borges RL, Fanelli C. Brazilian red propolis attenuates hypertension and renal damage in 5/6 renal ablation model. PLoS One. 2015 Jan 21;10(1):e0116535. doi: 10.1371/journal.pone.0116535. eCollection 2015.
- Background: PubMed 28910789Dai L, Golembiewska E, Lindholm B, Stenvinkel P. End-Stage Renal Disease, Inflammation and Cardiovascular Outcomes. Contrib Nephrol. 2017;191:32-43. doi: 10.1159/000479254. Epub 2017 Sep 14.
- Results publication: PubMed 31023272Silveira MAD, Teles F, Berretta AA, Sanches TR, Rodrigues CE, Seguro AC, Andrade L. Effects of Brazilian green propolis on proteinuria and renal function in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled trial. BMC Nephrol. 2019 Apr 25;20(1):140. doi: 10.1186/s12882-019-1337-7.
- Results publication: PubMed 30281126Cobo G, Lindholm B, Stenvinkel P. Chronic inflammation in end-stage renal disease and dialysis. Nephrol Dial Transplant. 2018 Oct 1;33(suppl_3):iii35-iii40. doi: 10.1093/ndt/gfy175.
- Derived from this study: PubMed 36457860Duarte Silveira MA, Malta-Santos H, Reboucas-Silva J, Teles F, Batista Dos Santos Galvao E, Pinto de Souza S, Dantas Dutra FR, Dantas Gomes MM, Teixeira MB, Miranda Rebelo da Conceicao LF, Nascimento CS, Vasques Nonaka CK, Cezar RS, Pena Batista PB, Berretta AA, Borges VM, da Hora Passos R. Effects of Standardized Brazilian Green Propolis Extract (EPP-AF(R)) on Inflammation in Haemodialysis Patients: A Clinical Trial. Int J Nephrol. 2022 Nov 22;2022:1035475. doi: 10.1155/2022/1035475. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease Requiring Chronic Dialysis
Recruiting
DIALysis With EXpanded Solute Removal
Chronic Kidney Disease Requiring Hemodialysis, End-Stage Kidney Disease (ESKD)
RecruitingPhase 2
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
Hyperphosphatemia, Chronic Kidney Disease Requiring Chronic Dialysis
Recruiting
Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients
Chronic Kidney Disease Requiring Hemodialysis
Recruiting
Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)
Chronic Kidney Disease (CKD) Stage 5, Kidney Dysfunction Requiring Dialysis (KDRD)
Recruiting
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
Kidney Disease, End-Stage, End-stage Renal Disease
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.
Marcelo Silveira, MD, PhD principal investigator
Hospital São Rafael S.A
Flávio Teles, MD, PhD principal investigator
Universidade Estadual de Ciências da Saúde de Alagoas
Rogério Passos principal investigator
Hospital São Rafael S.A
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 Propolis Period (Green Propolis 250mg/day) in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 7 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 18 May 2022. 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 Brazil. 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?
Change in serum level of High-sensitivity C-reactive protein from baseline to end of study periods. (time frame: 8 weeks). 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 NCT04072341, 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 18 May 2022.