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Effect of Enalapril and Losartan Association Therapy on Proteinuria and Inflammatory Biomarkers in Diabetic Nephropathy: a Clinical Trial on Type 2 Diabetes Mellitus

Primary Purpose

Macroalbuminuric Diabetic Nephropathy

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
enalapril
losartan
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macroalbuminuric Diabetic Nephropathy focused on measuring diabetic nephropathy, proteinuria, CKD progression, dialysis

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diabetic nephropathy characterised by a daily proteinuria superior to 500 mg
  • type II diabetes

Exclusion Criteria:

  • type 1 diabetes
  • serum creatinine > 2.5 mg/dL or creatinine clearance lower than 30 ml/min
  • serum potassium > 5.5 mEq/L
  • intolerance or allergy to ACE inhibitors or BRA
  • pregnancy
  • hepatitis C or B
  • HIV
  • current chemotherapy treatment

Sites / Locations

  • Nephrology Department, Sao Paulo University Medical School

Outcomes

Primary Outcome Measures

effect of treatment on proteinuria after 8 months of follow-up

Secondary Outcome Measures

effect of treatment on urinary inflammatory biomarkers after 8 months of follow-up
incidence of hyperkalemia

Full Information

First Posted
January 8, 2007
Last Updated
August 3, 2011
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00419835
Brief Title
Effect of Enalapril and Losartan Association Therapy on Proteinuria and Inflammatory Biomarkers in Diabetic Nephropathy: a Clinical Trial on Type 2 Diabetes Mellitus
Official Title
Effect of Enalapril and Losartan Association Therapy on Proteinuria and Inflammatory Biomarkers in Diabetic Nephropathy: a Clinical Trial on Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

5. Study Description

Brief Summary
Chronic kidney disease (CKD)has become a significant health problem worldwide. Strategies to decrease the rate of progression of this disease and reduce the number of patients needing dialysis or renal transplantation are urgently needed. In this study we wish to compare the effect of dual blockade of renin-angiotensin system (ACE inhibitors plus angiotensin II receptor blocker) compared to the effect of ACE inhibitor monotherapy in patients with diabetic chronic nephropathy.
Detailed Description
Diabetic kidney disease is the current leading cause of chronic kidney disease (CKD) in the world. Despite all efforts to control this disease, rates of CKD progression are still high and a significant number of patients will ultimately need renal replacement therapy. Pharmacological blockade of renin-angiotensin system is one of the key elements of CKD secondary prevention, and ACE inhibitors or angiotensin II receptor 1 blocker (ARB)can be used for this purpose. However, it is still not clear if dual blockade (ACEi and ARBs simultaneously)is superior to monotherapy with ACE inhibitors or ARBs. A recent trial has suggested that dual blockade is superior to monotherapy in non-diabetic chronic kidney disease. The purpose of this trial is to evaluate the effect of combination therapy compared to ACE inhibitors alone in type 2 diabetic patients with macroalbuminuric diabetic nephropathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macroalbuminuric Diabetic Nephropathy
Keywords
diabetic nephropathy, proteinuria, CKD progression, dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
enalapril
Intervention Type
Drug
Intervention Name(s)
losartan
Primary Outcome Measure Information:
Title
effect of treatment on proteinuria after 8 months of follow-up
Secondary Outcome Measure Information:
Title
effect of treatment on urinary inflammatory biomarkers after 8 months of follow-up
Title
incidence of hyperkalemia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diabetic nephropathy characterised by a daily proteinuria superior to 500 mg type II diabetes Exclusion Criteria: type 1 diabetes serum creatinine > 2.5 mg/dL or creatinine clearance lower than 30 ml/min serum potassium > 5.5 mEq/L intolerance or allergy to ACE inhibitors or BRA pregnancy hepatitis C or B HIV current chemotherapy treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Zatz, Full Professor of Nephrology
Organizational Affiliation
Nephrology Department, Sao Paulo University Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Nephrology Department, Sao Paulo University Medical School
City
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22981148
Citation
Titan SM, Vieira JM Jr, Dominguez WV, Moreira SR, Pereira AB, Barros RT, Zatz R. Urinary MCP-1 and RBP: independent predictors of renal outcome in macroalbuminuric diabetic nephropathy. J Diabetes Complications. 2012 Nov-Dec;26(6):546-53. doi: 10.1016/j.jdiacomp.2012.06.006. Epub 2012 Sep 12.
Results Reference
derived
PubMed Identifier
20966122
Citation
Titan SM, Zatz R, Graciolli FG, dos Reis LM, Barros RT, Jorgetti V, Moyses RM. FGF-23 as a predictor of renal outcome in diabetic nephropathy. Clin J Am Soc Nephrol. 2011 Feb;6(2):241-7. doi: 10.2215/CJN.04250510. Epub 2010 Oct 21.
Results Reference
derived

Learn more about this trial

Effect of Enalapril and Losartan Association Therapy on Proteinuria and Inflammatory Biomarkers in Diabetic Nephropathy: a Clinical Trial on Type 2 Diabetes Mellitus

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