NCT00419835

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2005

Typical duration for phase_4

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

Study Start

First participant enrolled

May 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

August 4, 2011

Status Verified

January 1, 2007

Enrollment Period

2.3 years

First QC Date

January 8, 2007

Last Update Submit

August 3, 2011

Conditions

Macroalbuminuric Diabetic Nephropathy

Keywords

diabetic nephropathyproteinuriaCKD progressiondialysis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

  • incidence of hyperkalemia

Interventions

enalaprilDRUG
losartanDRUG

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology Department, Sao Paulo University Medical School

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (3)

  • Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.

    PMID: 38682786DERIVED

  • 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.

    PMID: 22981148DERIVED

  • 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.

    PMID: 20966122DERIVED

MeSH Terms

Conditions

Diabetic NephropathiesProteinuria

Interventions

EnalaprilLosartan

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Roberto Zatz, Full Professor of Nephrology

    Nephrology Department, Sao Paulo University Medical School

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2007

First Posted

January 9, 2007

Study Start

May 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

August 4, 2011

Record last verified: 2007-01

Locations

BR(1)