search
Back to results

Propolis Effects in Patients With Chronic Kidney Disease

Primary Purpose

Chronic Kidney Diseases

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Propolis
Placebo
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Proteinuria, Propolis, Chronic Kidney Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Sao Paulo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Propolis

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Reducing Proteinuria
Reduction from baseline proteinuria.

Secondary Outcome Measures

Protection of the glomerular filtration rate
Maintaining glomerular filtration rate or inferior reduction to 5 ml per minute per 1.73 m2 of body-surface area from baseline.

Full Information

First Posted
May 4, 2016
Last Updated
April 30, 2018
Sponsor
University of Sao Paulo General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02766036
Brief Title
Propolis Effects in Patients With Chronic Kidney Disease
Official Title
Propolis Effects on Proteinuria and Kidney Function in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Proteinuria, Propolis, Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propolis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Propolis
Intervention Description
Patients will receive 500 mg / day of the propolis extract in the form of tablets split in two daily doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will receive 500 mg / day of the placebo in the form of tablets split in two daily doses
Primary Outcome Measure Information:
Title
Reducing Proteinuria
Description
Reduction from baseline proteinuria.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Protection of the glomerular filtration rate
Description
Maintaining glomerular filtration rate or inferior reduction to 5 ml per minute per 1.73 m2 of body-surface area from baseline.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
General Hospital
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
10665935
Citation
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.
Results Reference
background
PubMed Identifier
26220625
Citation
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.
Results Reference
background
PubMed Identifier
25607548
Citation
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.
Results Reference
result
PubMed Identifier
23320022
Citation
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.
Results Reference
result
PubMed Identifier
15660575
Citation
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.
Results Reference
result
PubMed Identifier
21965377
Citation
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.
Results Reference
result
PubMed Identifier
17167116
Citation
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.
Results Reference
result
PubMed Identifier
31023272
Citation
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.
Results Reference
derived

Learn more about this trial

Propolis Effects in Patients With Chronic Kidney Disease

We'll reach out to this number within 24 hrs