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Inhibition of the Renin Angiotensin System Plus Corticosteroids for the Treatment of Proteinuria in IGA Nephropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00367562
First Posted: August 23, 2006
Last Update Posted: November 1, 2006
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:
Hospital Britanico
  Purpose
TO ASSESS THE EFFICACY OF THE RENIN ANGIOTENSIN SYSTEM PLUS STEROIDS TO DECREASE THE AMOUNT OF PROTEINURIA IN IGA NEPHROPATHY

Condition Intervention Phase
IGA Nephropathy Drug: ENALAPRIL VALSARTAN METHYLPREDNISONE Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Open Label Uncontrolled Trial of the Dual Blockade of the Renin Angiotensin System With Enalapril Plus Valsartan Combined With Oral Methylprednisolone for the Treatment of Proteinuria in IGA Nephropathy

Resource links provided by NLM:


Further study details as provided by Hospital Britanico:

Primary Outcome Measures:
  • DAILY PROTEINURIA

Secondary Outcome Measures:
  • RENAL FUNCTION AS ASSESSED BY SERUM CREATININE

Estimated Enrollment: 20
Study Start Date: January 1996
Estimated Study Completion Date: December 2005
Detailed Description:
Patients whose proteinuria was > 0.5 g/day were to receive enalapril plus valsartan coupled with oral 0.5 g/day of methylprednisone for 6 months.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PATIENTES WITH IGA NEPHROPATHY WITH PROTEINURIA OVER 0.5 G/DAY

Exclusion Criteria:

  • MALIGNANCY, RENAL FAILURE
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367562


Locations
Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, Argentina, 1280
Sponsors and Collaborators
Hospital Britanico
Investigators
Principal Investigator: hernan trimarchi, M.D. Hospital Britanico
  More Information

Additional Information:
Publications:

ClinicalTrials.gov Identifier: NCT00367562     History of Changes
Other Study ID Numbers: TEREKOWA33
First Submitted: August 22, 2006
First Posted: August 23, 2006
Last Update Posted: November 1, 2006
Last Verified: January 1996

Keywords provided by Hospital Britanico:
IGA NEPHROPATHY
STEROIDS
ENALAPRIL
VALSARTAN
PROTEINURIA
IMMUNOGLOBULIN A NEPHROPATHY (IGA NEPHROPATHY)

Additional relevant MeSH terms:
Kidney Diseases
Proteinuria
Glomerulonephritis, IGA
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Valsartan
Enalapril
Enalaprilat
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors