ClinicalTrials.gg
CompletedNCT00367562Updated Nov 1, 2006

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

A Phase 4 interventional study of ENALAPRIL VALSARTAN METHYLPREDNISONE in IGA Nephropathy, sponsored by Hospital Britanico. Completed at 1 site in Argentina. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2006-11-01.

Sponsored by Hospital Britanico · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
21 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 19 studies in Glomerulonephritis, IGA with a site in Argentina — 6 open to participants now, 12 under way, 10 of them phase 3. Glomerulonephritis, IGA · Argentina.

Enrollment
18th of 19
20 · median 365
Started
1996
the only one that year
Phase 4
Only one
of the 19
Registered
1st of 19
by date
Lead sponsor
1 of 19
Hospital Britanico

Among the 19 studies in Glomerulonephritis, IGA with a site in Argentina, this one is the 18th largest by enrollment, is the only one that started in 1996, is the only one in phase 4, and was the 1st registered.

By phase

19 studies; the count open now beside each. This study's row is marked.

Phase 313 · 4 open
Phase 24 · 1 open
Phase 2/31 · 1 open
Phase 4this study1 · 0 open

By the year they started

First in 1996; this study’s year is marked. 1 started in 1996.

Size and results

Median enrollment 365 across the 19 interventional studies. Of the 7 that completed or were terminated, 6 (86%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 19 studies in Glomerulonephritis, IGA with a site in Argentina, or all of them as a file.
02

Study summary

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

Read the 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.

03

Conditions studied

  • IGA Nephropathy

Keywords

  • IGA NEPHROPATHY
  • STEROIDS
  • ENALAPRIL
  • VALSARTAN
  • PROTEINURIA
  • IMMUNOGLOBULIN A NEPHROPATHY (IGA NEPHROPATHY)
04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • , RENAL FAILURE
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants

Interventions

  • DrugENALAPRIL VALSARTAN METHYLPREDNISONE
06

What researchers measure

Primary outcomes

  1. DAILY PROTEINURIA

Secondary outcomes

  1. RENAL FUNCTION AS ASSESSED BY SERUM CREATININE

07

Study locations

1 site
  • Hospital Britanico de Buenos Aires
    Buenos Aires, 1280, Argentina
08

References and documents

Publications

  • 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. PubMed 15930092 ↗
  • 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. PubMed 14640237 ↗
  • 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. PubMed 10213639 ↗
  • 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. PubMed 11431176 ↗
  • Appel GB, Waldman M. The IgA nephropathy treatment dilemma. Kidney Int. 2006 Jun;69(11):1939-44. doi: 10.1038/sj.ki.5000434. PubMed 16641925 ↗
  • 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. PubMed 9890315 ↗
  • 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. PubMed 2797345 ↗
  • 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. PubMed 12722031 ↗
  • 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. PubMed 10093981 ↗
  • 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. PubMed 15363047 ↗

Related links

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 1996 and a completion of Dec 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2006
First posted
Aug 23, 2006
Start
Jan 1996
Completion
Dec 2005
Last update
Nov 1, 2006
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Nov 1, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00367562
Lead sponsor
Hospital Britanico
First posted
Aug 23, 2006
Start date
Jan 1996
Completion
Dec 2005
Last update
Nov 1, 2006

Study contacts

hernan trimarchi, M.D.
principal investigator · Hospital Britanico
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 1996. You cannot join it, but the record below documents what was studied.

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