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

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.
 
ClinicalTrials.gov Identifier: NCT00367562
Recruitment Status : Completed
First Posted : August 23, 2006
Last Update Posted : November 1, 2006
Sponsor:
Information provided by:
Hospital Britanico

Tracking Information
First Submitted Date  ICMJE August 22, 2006
First Posted Date  ICMJE August 23, 2006
Last Update Posted Date November 1, 2006
Study Start Date  ICMJE January 1996
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2006)
DAILY PROTEINURIA
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2006)
RENAL FUNCTION AS ASSESSED BY SERUM CREATININE
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhibition of the Renin Angiotensin System Plus Corticosteroids for the Treatment of Proteinuria in IGA Nephropathy
Official Title  ICMJE 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
Brief Summary TO ASSESS THE EFFICACY OF THE RENIN ANGIOTENSIN SYSTEM PLUS STEROIDS TO DECREASE THE AMOUNT OF PROTEINURIA IN IGA NEPHROPATHY
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE IGA Nephropathy
Intervention  ICMJE Drug: ENALAPRIL VALSARTAN METHYLPREDNISONE
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 22, 2006)
20
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • MALIGNANCY, RENAL FAILURE
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00367562
Other Study ID Numbers  ICMJE TEREKOWA33
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hospital Britanico
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: hernan trimarchi, M.D. Hospital Britanico
PRS Account Hospital Britanico
Verification Date January 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP