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

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ClinicalTrials.gov Identifier: NCT00367562

Recruitment Status : Completed

First Posted : August 23, 2006

Last Update Posted : November 1, 2006

Sponsor:

Information provided by:

Hospital Britanico

Study Description

Brief Summary:

TO ASSESS THE EFFICACY OF THE RENIN ANGIOTENSIN SYSTEM PLUS STEROIDS TO DECREASE THE AMOUNT OF PROTEINURIA IN IGA NEPHROPATHY

Condition or disease	Intervention/treatment	Phase
IGA Nephropathy	Drug: ENALAPRIL VALSARTAN METHYLPREDNISONE	Phase 4

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 Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	20 participants
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
Study Start Date :	January 1996
Study Completion Date :	December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Drug Information available for: Enalapril Enalapril maleate Enalaprilat Valsartan

Genetic and Rare Diseases Information Center resources: IgA Nephropathy Glomerulonephritis

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

DAILY PROTEINURIA

Secondary Outcome Measures :

RENAL FUNCTION AS ASSESSED BY SERUM CREATININE

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	21 Years to 70 Years (Adult, Older Adult)
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:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Barratt J, Feehally J. IgA nephropathy. J Am Soc Nephrol. 2005 Jul;16(7):2088-97. Epub 2005 Jun 1. Review.

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.

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.

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.

Appel GB, Waldman M. The IgA nephropathy treatment dilemma. Kidney Int. 2006 Jun;69(11):1939-44. Review.

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.

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.

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.

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.

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.


ClinicalTrials.gov Identifier:	NCT00367562 History of Changes
Other Study ID Numbers:	TEREKOWA33
First Posted:	August 23, 2006 Key Record Dates
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

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