- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02766036
Propolis Effects in Patients With Chronic Kidney Disease
April 30, 2018 updated by: Marcelo Augusto Duarte Silveira, University of Sao Paulo General Hospital
Propolis Effects on Proteinuria and Kidney Function in Patients With Chronic Kidney Disease
The aim of this study is to determine the impact of Propolis on proteinuria reduction and protection of the glomerular filtration rate in chronic renal failure patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Sao Paulo, Brazil, 05403-000
- University of Sao Paulo General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- older than 18 years;
- less than 90 years;
- glomerular filtration rate between 25 and 70 ml / min;
- proteinuria in the urine 24 hours more than 300 mg or protein / creatinina in isolated urine greater than 0.3g / g or microalbuminuria (albumin / creatinine ratio) between 30-300 mg / g.
Exclusion Criteria:
- Pregnants;
- Neoplasia carrier;
- Renal transplant patients;
- Patients who refuse to participate in the study.
- Glomerulopathy on Immunosuppression
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Propolis
Patients will continue to receive standard treatment for their comorbidities, determined by the attending physician.
Patients will receive 500 mg / day of the propolis extract in the form of tablets split in two daily doses.
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Patients will receive 500 mg / day of the propolis extract in the form of tablets split in two daily doses
|
Placebo Comparator: Placebo
Patients will continue to receive standard treatment for their comorbidities, determined by the attending physician.
Patients will receive 500 mg / day of the propolis-placebo in the form of tablets split in two daily doses.
|
Patients will receive 500 mg / day of the placebo in the form of tablets split in two daily doses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reducing Proteinuria
Time Frame: One year
|
Reduction from baseline proteinuria.
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One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protection of the glomerular filtration rate
Time Frame: One year
|
Maintaining glomerular filtration rate or inferior reduction to 5 ml per minute per 1.73 m2 of body-surface area from baseline.
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One year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: General Hospital, University of São Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Machado JL, Assuncao AK, da Silva MC, Dos Reis AS, Costa GC, Arruda Dde S, Rocha BA, Vaz MM, Paes AM, Guerra RN, Berretta AA, do Nascimento FR. Brazilian green propolis: anti-inflammatory property by an immunomodulatory activity. Evid Based Complement Alternat Med. 2012;2012:157652. doi: 10.1155/2012/157652. Epub 2012 Dec 19.
- Fujihara CK, DE Lourdes Noronha I, Malheiros DMAC, Antunes GR, DE Oliveira IB, Zatz R. Combined mycophenolate mofetil and losartan therapy arrests established injury in the remnant kidney. J Am Soc Nephrol. 2000 Feb;11(2):283-290. doi: 10.1681/ASN.V112283.
- da Costa MF, Liborio AB, Teles F, Martins Cda S, Soares PM, Meneses GC, Rodrigues FA, Leal LK, Miron D, Silva AH, Martins AM. Red propolis ameliorates ischemic-reperfusion acute kidney injury. Phytomedicine. 2015 Aug 15;22(9):787-95. doi: 10.1016/j.phymed.2015.03.017. Epub 2015 Apr 12.
- 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.
- Himmelfarb J. Linking oxidative stress and inflammation in kidney disease: which is the chicken and which is the egg? Semin Dial. 2004 Nov-Dec;17(6):449-54. doi: 10.1111/j.0894-0959.2004.17605.x.
- Inker LA, Coresh J, Levey AS, Tonelli M, Muntner P. Estimated GFR, albuminuria, and complications of chronic kidney disease. J Am Soc Nephrol. 2011 Dec;22(12):2322-31. doi: 10.1681/ASN.2010111181. Epub 2011 Sep 30.
- Shah SV, Baliga R, Rajapurkar M, Fonseca VA. Oxidants in chronic kidney disease. J Am Soc Nephrol. 2007 Jan;18(1):16-28. doi: 10.1681/ASN.2006050500. Epub 2006 Dec 13.
- Silveira 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
May 4, 2016
First Submitted That Met QC Criteria
May 5, 2016
First Posted (Estimate)
May 9, 2016
Study Record Updates
Last Update Posted (Actual)
May 3, 2018
Last Update Submitted That Met QC Criteria
April 30, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 54326916.4.0000.0068
- USP Brazil (Other Identifier: University of São Paulo School of Medicine)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
The data will be evaluated monthly by researchers at the scientific meetings of the department.
Data from this study will be considered joint property of the parties involved.
Researchers are, however, responsible for committing to make public the results.
IPD Sharing Time Frame
The results of this research will be published to become public domain.
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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