NCT02766036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

May 4, 2016

Last Update Submit

April 30, 2018

Conditions

Chronic Kidney Diseases

Keywords

ProteinuriaPropolisChronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Reducing Proteinuria

    Reduction from baseline proteinuria.

    One year

Secondary Outcomes (1)

  • Protection of the glomerular filtration rate

    One year

Study Arms (2)

Propolis

ACTIVE COMPARATOR

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.

Drug: Propolis

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

PropolisDRUG

Patients will receive 500 mg / day of the propolis extract in the form of tablets split in two daily doses

Propolis
PlaceboDRUG

Patients will receive 500 mg / day of the placebo in the form of tablets split in two daily doses

Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnants;
  • Neoplasia carrier;
  • Renal transplant patients;
  • Patients who refuse to participate in the study.
  • Glomerulopathy on Immunosuppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, 05403-000, Brazil

Location

Related Publications (9)

  • 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.

    PMID: 10665935BACKGROUND

  • 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.

    PMID: 26220625BACKGROUND

  • 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.

    PMID: 25607548RESULT

  • 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.

    PMID: 23320022RESULT

  • 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.

    PMID: 15660575RESULT

  • 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.

    PMID: 21965377RESULT

  • 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.

    PMID: 17167116RESULT

  • Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

    PMID: 37916745DERIVED

  • 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.

    PMID: 31023272DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicProteinuria

Interventions

Propolis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUrination DisordersUrological ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Resins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex Mixtures

Study Officials

  • General Hospital

    University of Sao Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 9, 2016

Study Start

December 1, 2016

Primary Completion

February 1, 2018

Study Completion

March 1, 2018

Last Updated

May 3, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
The results of this research will be published to become public domain.

Locations

BR(1)