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

This study has been completed.

First Received on August 22, 2006. Last Updated on October 31, 2006 History of Changes

Sponsor:	Hospital Britanico
Information provided by:	Hospital Britanico
ClinicalTrials.gov Identifier:	NCT00367562

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 IV

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:

Drug Information available for: Enalapril Enalapril maleate Enalaprilat Valsartan

U.S. FDA Resources

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

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:

Related Info This link exits the ClinicalTrials.gov site

Publications:

1. Barratt J, Feehally J. IgA nephropathy. J Am Soc Nephrol 2005: 16: 2088-2097.

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.

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-

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
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:

Glomerulonephritis, IGA
Kidney Diseases
Proteinuria
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Enalapril

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

ClinicalTrials.gov processed this record on February 09, 2012