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Enalapril in Collagen Type 4 Nephropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01465126
First Posted: November 4, 2011
Last Update Posted: November 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maria Helena Vaisbich, University of Sao Paulo
  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:


Further study details as provided by Maria Helena Vaisbich, University of Sao Paulo:

Primary Outcome Measures:
  • proteinuria [ Time Frame: two years ]
    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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Responsible Party: Maria Helena Vaisbich, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01465126     History of Changes
Other Study ID Numbers: Registry Identifier
First Submitted: October 27, 2011
First Posted: November 4, 2011
Last Update Posted: November 4, 2011
Last Verified: November 2011

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