IGA NephropathyPhase 4NCT00367562
Inhibition of the Renin Angiotensin System Plus Corticosteroids for the Treatment of Proteinuria in IGA Nephropathy
A Phase 4 study testing ENALAPRIL VALSARTAN METHYLPREDNISONE in people with IGA Nephropathy, run by Hospital Britanico at 1 site in Argentina.
Trial summary
TO ASSESS THE EFFICACY OF THE RENIN ANGIOTENSIN SYSTEM PLUS STEROIDS TO DECREASE THE AMOUNT OF PROTEINURIA IN IGA NEPHROPATHY Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- IGA Nephropathy
- What is being tested?
- ENALAPRIL VALSARTAN METHYLPREDNISONE
- How many people
- 20 participants
- Where
- 1 siteArgentina
- Study dates
- Jan 1996to Dec 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PATIENTES WITH IGA NEPHROPATHY WITH PROTEINURIA OVER 0.5 G/DAY
Who cannot join
- MALIGNANCY, RENAL FAILURE
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Britanico de Buenos Aires
Buenos Aires, Buenos Aires, 1280
About this study
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
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.
- Conditions
- IGA Nephropathy
- Being tested
- ENALAPRIL VALSARTAN METHYLPREDNISONE
- Keywords
- IGA NEPHROPATHY, STEROIDS, ENALAPRIL, VALSARTAN, PROTEINURIA, IMMUNOGLOBULIN A NEPHROPATHY (IGA NEPHROPATHY)
- Medical subject headings
- Glomerulonephritis, IGA, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENALAPRIL VALSARTAN METHYLPREDNISONEDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
DAILY PROTEINURIA
Secondary outcomes (1)
RENAL FUNCTION AS ASSESSED BY SERUM CREATININE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startJan 1996
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for IGA NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Hospital Britanico
- Sponsor type
- University, hospital or other
- Investigators
- hernan trimarchi, M.D., Principal investigator, Hospital Britanico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367562
- Sponsor's protocol ID
- TEREKOWA33
- Status last verified
- Jan 1996
- First submitted
- 22 Aug 2006
- Last updated
- 1 Nov 2006
- Results posted
- No
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 15930092Song 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 14640237Russo 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 10213639Russo 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 11431176Appel GB, Waldman M. The IgA nephropathy treatment dilemma. Kidney Int. 2006 Jun;69(11):1939-44. doi: 10.1038/sj.ki.5000434.
PubMed 16641925Yoshikawa 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 9890315Kobayashi 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 2797345Katafuchi 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 12722031Pozzi 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 10093981Samuels 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00367562
- Acronym / sponsor ID
- TEREKOWA33
- Conditions
- IGA Nephropathy
- Keywords
- IGA NEPHROPATHY, STEROIDS, ENALAPRIL, VALSARTAN, PROTEINURIA, IMMUNOGLOBULIN A NEPHROPATHY (IGA NEPHROPATHY)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Hospital BritanicoUniversity, hospital or other
- Study start
- Jan 1996
- Study completion
- Dec 2005
- First posted
- 23 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PATIENTES WITH IGA NEPHROPATHY WITH PROTEINURIA OVER 0.5 G/DAY
Key exclusion criteria (1 listed)
- MALIGNANCY, RENAL FAILURE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENALAPRIL VALSARTAN METHYLPREDNISONE | Drug | – |
Primary outcome
DAILY PROTEINURIA
1 secondary outcome
RENAL FUNCTION AS ASSESSED BY SERUM CREATININE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2006.
- Background: PubMed 15930092Barratt 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.
- Background: PubMed 14640237Song 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.
- Background: PubMed 10213639Russo 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.
- Background: PubMed 11431176Russo 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.
- Background: PubMed 16641925Appel GB, Waldman M. The IgA nephropathy treatment dilemma. Kidney Int. 2006 Jun;69(11):1939-44. doi: 10.1038/sj.ki.5000434.
- Background: PubMed 9890315Yoshikawa 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.
- Background: PubMed 2797345Kobayashi 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.
- Background: PubMed 12722031Katafuchi 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.
- Background: PubMed 10093981Pozzi 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.
- Background: PubMed 15363047Samuels 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hernan trimarchi, M.D. principal investigator
Hospital Britanico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ENALAPRIL VALSARTAN METHYLPREDNISONE in people with IGA Nephropathy, run by Hospital Britanico at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAILY PROTEINURIA. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00367562, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2006.