NCT00367562

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 1996

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
9.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2006

Completed
Last Updated

November 1, 2006

Status Verified

January 1, 1996

First QC Date

August 22, 2006

Last Update Submit

October 31, 2006

Conditions

IGA Nephropathy

Keywords

IGA NEPHROPATHYSTEROIDSENALAPRILVALSARTANPROTEINURIAIMMUNOGLOBULIN A NEPHROPATHY (IGA NEPHROPATHY)

Outcome Measures

Primary Outcomes (1)

  • DAILY PROTEINURIA

Secondary Outcomes (1)

  • RENAL FUNCTION AS ASSESSED BY SERUM CREATININE

Interventions

ENALAPRIL VALSARTAN METHYLPREDNISONEDRUG

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • MALIGNANCY, RENAL FAILURE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Britanico de Buenos Aires

Buenos Aires, Buenos Aires, 1280, Argentina

Location

Related Publications (10)

  • 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.

    PMID: 15930092BACKGROUND

  • 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.

    PMID: 14640237BACKGROUND

  • 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.

    PMID: 10213639BACKGROUND

  • 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.

    PMID: 11431176BACKGROUND

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

    PMID: 16641925BACKGROUND

  • 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.

    PMID: 9890315BACKGROUND

  • 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.

    PMID: 2797345BACKGROUND

  • 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.

    PMID: 12722031BACKGROUND

  • 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.

    PMID: 10093981BACKGROUND

  • 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.

    PMID: 15363047BACKGROUND

Related Links

MeSH Terms

Conditions

Glomerulonephritis, IGAProteinuria

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • hernan trimarchi, M.D.

    Hospital Britanico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2006

First Posted

August 23, 2006

Study Start

January 1, 1996

Study Completion

December 1, 2005

Last Updated

November 1, 2006

Record last verified: 1996-01

Locations

AR(1)