IGA Nephropathy Clinical Trial
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
TO ASSESS THE EFFICACY OF THE RENIN ANGIOTENSIN SYSTEM PLUS STEROIDS TO DECREASE THE AMOUNT OF PROTEINURIA IN IGA NEPHROPATHY
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | December 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - PATIENTES WITH IGA NEPHROPATHY WITH PROTEINURIA OVER 0.5 G/DAY Exclusion Criteria: - MALIGNANCY, RENAL FAILURE |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Britanico de Buenos Aires | Buenos Aires |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Britanico |
Argentina,
Appel GB, Waldman M. The IgA nephropathy treatment dilemma. Kidney Int. 2006 Jun;69(11):1939-44. Review. — View Citation
Barratt J, Feehally J. IgA nephropathy. J Am Soc Nephrol. 2005 Jul;16(7):2088-97. Epub 2005 Jun 1. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | DAILY PROTEINURIA | |||
| Secondary | RENAL FUNCTION AS ASSESSED BY SERUM CREATININE |
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