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

NCT ID: NCT00367562

Last Updated: 2006-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-01-31

Study Completion Date

2005-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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IGA Nephropathy

Keywords

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IGA NEPHROPATHY STEROIDS ENALAPRIL VALSARTAN PROTEINURIA IMMUNOGLOBULIN A NEPHROPATHY (IGA NEPHROPATHY)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ENALAPRIL VALSARTAN METHYLPREDNISONE

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* MALIGNANCY, RENAL FAILURE
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Britanico

OTHER

Sponsor Role lead

Principal Investigators

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hernan trimarchi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Britanico

Locations

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Hospital Britanico de Buenos Aires

Buenos Aires, Buenos Aires, Argentina

Site Status

Countries

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Argentina

References

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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.

Reference Type BACKGROUND
PMID: 15930092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14640237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10213639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11431176 (View on PubMed)

Appel GB, Waldman M. The IgA nephropathy treatment dilemma. Kidney Int. 2006 Jun;69(11):1939-44. doi: 10.1038/sj.ki.5000434.

Reference Type BACKGROUND
PMID: 16641925 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9890315 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2797345 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12722031 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10093981 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15363047 (View on PubMed)

Related Links

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Other Identifiers

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TEREKOWA33

Identifier Type: -

Identifier Source: org_study_id