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Enalapril in Collagen Type 4 Nephropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maria Helena Vaisbich, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01465126
First received: October 27, 2011
Last updated: November 1, 2011
Last verified: November 2011
History of Changes
  Purpose

Background: Collagen IV-related nephropathies can lead to End Stage Renal Disease. Experimental studies have shown renin angiotensin aldosterone system blockade can reduce proteinuria and preserve renal function. In humans there is no proven treatment. Methods: This is a retrospective study of patients with Collagen IV-related nephropathies and proteinuria treated with enalapril analyzing the evolution of proteinuria and renal function, as well as predictive variables of progression to end stage renal disease. Outcome was creatinine clearance < 60 ml/min/1.73m2.


Condition
Collagen Type-4 Nephropathies

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Collagen Type 4-related Nephropathies: From Alport to Thin Membrane Nephropathy. A Series of Cases Treated With Angiotensin Converting Enzyme Inhibitor

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • proteinuria [ Time Frame: two years ] [ Designated as safety issue: No ]
    evaluate the proteinuria during two years of treatment with enalapril


Secondary Outcome Measures:
  • evaluate the creatinine clearance during treatment with enalapril [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: January 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with Collagen type 4 nephropathies and proteinuria followed in Pediatric Nephrology Unit of Instituto da Criança - HCFMUSP

Criteria

Inclusion Criteria:

  • age under 18 years old
  • non-adherent to the exams and evaluations

Exclusion Criteria:

  • creatinine clearance < 60 ml/minute/1.73m2BS
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Maria Helena Vaisbich, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01465126     History of Changes
Other Study ID Numbers: Registry Identifier
Study First Received: October 27, 2011
Last Updated: November 1, 2011
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
 Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013