Inhibition of the Renin Angiotensin System Plus Corticosteroids for the Treatment of Proteinuria in IGA Nephropathy
Primary Purpose
IGA Nephropathy
Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
ENALAPRIL VALSARTAN METHYLPREDNISONE
Sponsored by
About this trial
This is an interventional treatment trial for IGA Nephropathy focused on measuring IGA NEPHROPATHY, STEROIDS, ENALAPRIL, VALSARTAN, PROTEINURIA, IMMUNOGLOBULIN A NEPHROPATHY (IGA NEPHROPATHY)
Eligibility Criteria
Inclusion Criteria: PATIENTES WITH IGA NEPHROPATHY WITH PROTEINURIA OVER 0.5 G/DAY Exclusion Criteria: MALIGNANCY, RENAL FAILURE
Sites / Locations
- Hospital Britanico de Buenos Aires
Outcomes
Primary Outcome Measures
DAILY PROTEINURIA
Secondary Outcome Measures
RENAL FUNCTION AS ASSESSED BY SERUM CREATININE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00367562
Brief Title
Inhibition of the Renin Angiotensin System Plus Corticosteroids for the Treatment of Proteinuria in IGA Nephropathy
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 1996
Overall Recruitment Status
Completed
Study Start Date
January 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Britanico
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IGA Nephropathy
Keywords
IGA NEPHROPATHY, STEROIDS, ENALAPRIL, VALSARTAN, PROTEINURIA, IMMUNOGLOBULIN A NEPHROPATHY (IGA NEPHROPATHY)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ENALAPRIL VALSARTAN METHYLPREDNISONE
Primary Outcome Measure Information:
Title
DAILY PROTEINURIA
Secondary Outcome Measure Information:
Title
RENAL FUNCTION AS ASSESSED BY SERUM CREATININE
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PATIENTES WITH IGA NEPHROPATHY WITH PROTEINURIA OVER 0.5 G/DAY
Exclusion Criteria:
MALIGNANCY, RENAL FAILURE
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hernan trimarchi, M.D.
Organizational Affiliation
Hospital Britanico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Britanico de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
12. IPD Sharing Statement
Citations:
PubMed Identifier
15930092
Citation
Barratt J, Feehally J. IgA nephropathy. J Am Soc Nephrol. 2005 Jul;16(7):2088-97. doi: 10.1681/ASN.2005020134. Epub 2005 Jun 1. No abstract available.
Results Reference
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PubMed Identifier
14640237
Citation
Song JH, Lee SW, Suh JH, Kim ES, Hong SB, Kim KA, Kim MJ. The effects of dual blockade of the renin-angiotensin system on urinary protein and transforming growth factor-beta excretion in 2 groups of patients with IgA and diabetic nephropathy. Clin Nephrol. 2003 Nov;60(5):318-26. doi: 10.5414/cnp60318.
Results Reference
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PubMed Identifier
10213639
Citation
Russo D, Pisani A, Balletta MM, De Nicola L, Savino FA, Andreucci M, Minutolo R. Additive antiproteinuric effect of converting enzyme inhibitor and losartan in normotensive patients with IgA nephropathy. Am J Kidney Dis. 1999 May;33(5):851-6. doi: 10.1016/s0272-6386(99)70416-6.
Results Reference
background
PubMed Identifier
11431176
Citation
Russo D, Minutolo R, Pisani A, Esposito R, Signoriello G, Andreucci M, Balletta MM. Coadministration of losartan and enalapril exerts additive antiproteinuric effect in IgA nephropathy. Am J Kidney Dis. 2001 Jul;38(1):18-25. doi: 10.1053/ajkd.2001.25176.
Results Reference
background
PubMed Identifier
16641925
Citation
Appel GB, Waldman M. The IgA nephropathy treatment dilemma. Kidney Int. 2006 Jun;69(11):1939-44. doi: 10.1038/sj.ki.5000434.
Results Reference
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PubMed Identifier
9890315
Citation
Yoshikawa N, Ito H, Sakai T, Takekoshi Y, Honda M, Awazu M, Ito K, Iitaka K, Koitabashi Y, Yamaoka K, Nakagawa K, Nakamura H, Matsuyama S, Seino Y, Takeda N, Hattori S, Ninomiya M. A controlled trial of combined therapy for newly diagnosed severe childhood IgA nephropathy. The Japanese Pediatric IgA Nephropathy Treatment Study Group. J Am Soc Nephrol. 1999 Jan;10(1):101-9. doi: 10.1681/ASN.V101101.
Results Reference
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PubMed Identifier
2797345
Citation
Kobayashi Y, Hiki Y, Fujii K, Kurokawa A, Tateno S. Moderately proteinuric IgA nephropathy: prognostic prediction of individual clinical courses and steroid therapy in progressive cases. Nephron. 1989;53(3):250-6. doi: 10.1159/000185753.
Results Reference
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PubMed Identifier
12722031
Citation
Katafuchi R, Ikeda K, Mizumasa T, Tanaka H, Ando T, Yanase T, Masutani K, Kubo M, Fujimi S. Controlled, prospective trial of steroid treatment in IgA nephropathy: a limitation of low-dose prednisolone therapy. Am J Kidney Dis. 2003 May;41(5):972-83. doi: 10.1016/s0272-6386(03)00194-x.
Results Reference
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PubMed Identifier
10093981
Citation
Pozzi C, Bolasco PG, Fogazzi GB, Andrulli S, Altieri P, Ponticelli C, Locatelli F. Corticosteroids in IgA nephropathy: a randomised controlled trial. Lancet. 1999 Mar 13;353(9156):883-7. doi: 10.1016/s0140-6736(98)03563-6.
Results Reference
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PubMed Identifier
15363047
Citation
Samuels JA, Strippoli GF, Craig JC, Schena FP, Molony DA. Immunosuppressive treatments for immunoglobulin A nephropathy: a meta-analysis of randomized controlled trials. Nephrology (Carlton). 2004 Aug;9(4):177-85. doi: 10.1111/j.1440-1797.2004.00255.x.
Results Reference
background
Links:
URL
http://www.asn-online.org
Description
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Inhibition of the Renin Angiotensin System Plus Corticosteroids for the Treatment of Proteinuria in IGA Nephropathy
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