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

This study has been completed.
Sponsor:
Information provided by:
Hospital Britanico
ClinicalTrials.gov Identifier:
NCT00367562
First received: August 22, 2006
Last updated: October 31, 2006
Last verified: January 1996
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
1. Barratt J, Feehally J. IgA nephropathy. J Am Soc Nephrol 2005: 16: 2088-2097.
Yoshikawa N, Ito H, Sakai T, et al. A controlled trial of combined therapy for newly diagnosed severe childhood IgA nephropathy. J Am Soc Nephrol 1999; 10: 101-

ClinicalTrials.gov Identifier: NCT00367562     History of Changes
Other Study ID Numbers: TEREKOWA33
Study First Received: August 22, 2006
Last Updated: October 31, 2006
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014