Propolis Effects in Patients With Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

Propolis Effects on Proteinuria and Kidney Function in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766036
• Other study ID #: 54326916.4.0000.0068
• Secondary ID: USP Brazil
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2016
• Est. completion date: March 2018

Study information

• Verified date: April 2018
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Propolis
Patients will receive 500 mg / day of the propolis extract in the form of tablets split in two daily doses
• Placebo
Patients will receive 500 mg / day of the placebo in the form of tablets split in two daily doses

Locations

Country	Name	City	State
Brazil	University of Sao Paulo General Hospital	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

da Costa MF, Libório 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. — View Citation

Fujihara CK, Noronha IL, Malheiros, 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):283-90. — View 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. Review. — View 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. — View Citation

Machado JL, Assunção 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 Alt — View Citation

Shah SV, Baliga R, Rajapurkar M, Fonseca VA. Oxidants in chronic kidney disease. J Am Soc Nephrol. 2007 Jan;18(1):16-28. Epub 2006 Dec 13. Review. — View Citation

Teles F, da Silva TM, da Cruz Júnior FP, Honorato VH, de Oliveira Costa H, Barbosa AP, de Oliveira SG, Porfírio Z, Libório AB, Borges RL, Fanelli C. Brazilian red propolis attenuates hypertension and renal damage in 5/6 renal ablation model. PLoS One. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reducing Proteinuria	Reduction from baseline proteinuria.	One year
Secondary	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.	One year