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

• ClinicalTrials.gov Identifier: NCT00367562
• Recruitment Status: Completed
• First Posted: August 23, 2006
• Last Update Posted: November 1, 2006
• Sponsor: Hospital Britanico
• Information provided by: Hospital Britanico

Tracking Information

• First Submitted Date: August 22, 2006
• First Posted Date: August 23, 2006
• Last Update Posted Date: November 1, 2006
• Study Start Date: January 1996
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: August 22, 2006): DAILY PROTEINURIA
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: August 22, 2006): RENAL FUNCTION AS ASSESSED BY SERUM CREATININE
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Inhibition of the Renin Angiotensin System Plus Corticosteroids for the Treatment of Proteinuria in IGA Nephropathy
• 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
• Brief Summary: TO ASSESS THE EFFICACY OF THE RENIN ANGIOTENSIN SYSTEM PLUS STEROIDS TO DECREASE THE AMOUNT OF PROTEINURIA IN IGA NEPHROPATHY
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: IGA Nephropathy
• Intervention: Drug: ENALAPRIL VALSARTAN METHYLPREDNISONE
• Study Arms: Not Provided

Publications *

• Barratt J, Feehally J. IgA nephropathy. J Am Soc Nephrol. 2005 Jul;16(7):2088-97. Epub 2005 Jun 1. Review.
• 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. Review.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: August 22, 2006): 20
• Original Enrollment: Same as current
• Study Completion Date: December 2005
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• MALIGNANCY, RENAL FAILURE

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina

Administrative Information

• NCT Number: NCT00367562
• Other Study ID Numbers: TEREKOWA33
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Hospital Britanico
• Collaborators: Not Provided

Investigators

• Principal Investigator: hernan trimarchi, M.D.; Hospital Britanico

• PRS Account: Hospital Britanico
• Verification Date: January 1996