A Research Study to Evaluate the Renal (Kidney) Protective Effects of Losartan in Patients With Non-insulin Dependent Diabetes (0954-147)(COMPLETED)
NCT ID: NCT00308347
Last Updated: 2022-02-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1513 participants
Study Classification
INTERVENTIONAL
Study Start Date
1996-05-31
Study Completion Date
2001-04-30
Brief Summary
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Evaluate the effect of Losartan in reducing kidney disease in patients with Non-insulin Dependent Diabetes and Nephropathy (kidney damage that usually accompanies late stage Diabetes Mellitus).
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Detailed Description
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Conditions
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Type 2 Diabetes
Nephropathy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Interventions
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MK0954, losartan / Duration of Treatment: mean 3.4 years
Intervention Type
DRUG
Placebo / Duration of Treatment: mean 3.4 years
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Diabetes diagnosed after the age of 30
* Insulin not required within 6 months of first being diagnosed with Non-insulin Dependent Diabetes Mellitus
* No history of diabetic ketoacidosis
* Patients may be currently treated with diet, oral hypoglycemics or insulin
* Patients must have proteinuria defined as: Urine protein \>1+ on dipstick at the initial screening visit
* Patients with hypertension (high blood pressure) must have a sitting blood pressure \>200/110 mm Hg at Visit 1
* Insulin not required within 6 months of first being diagnosed with Non-insulin Dependent Diabetes Mellitus
* No history of diabetic ketoacidosis
* Patients may be currently treated with diet, oral hypoglycemics or insulin
* Patients must have proteinuria defined as: Urine protein \>1+ on dipstick at the initial screening visit
* Patients with hypertension (high blood pressure) must have a sitting blood pressure \>200/110 mm Hg at Visit 1
Exclusion Criteria
* Patients with insulin-dependent diabetes mellitus (juvenile onset)
* Patients treated with an ACE inhibitor or angiotensin II antagonist (AIIA) for \>5 years
* Patients treated with ACE inhibitor or AIIA therapy for 5 years or less may enter the study provided therapy is discontinued during the 6 week screening period prior to randomization
* History of myocardial infarction (MI) (heart attack) or coronary artery bypass graft (CABG) surgery within the past 1 month
* History of cerebral vascular accident (CVA) (stroke) or percutaneous transluminal coronary angioplasty (PTCA) within the past 6 months
* History of transient ischemic attacks (TIA) within the past year. Patients with unstable angina are excluded until stabilized
* Heart failure requiring ACE inhibitor therapy
* Steroids (oral or parenteral) or immunosuppressives are not permitted. Debilitating psychological illness
* Evidence of significant hepatic (liver) dysfunction: History of allergy to losartan
* Known positive test for HIV or patients known to be hepatitis B or C antigen carriers
* Pregnant or nursing women
* Females of childbearing age must either be surgically sterilized or, if sexually active, using an effective form of contraception and may enter only if an exclusionary pregnancy test is done within approximately 72 hours prior to randomization
* Pregnancy tests will be done every 3 months during the study and at the time of discontinuation
* Patients treated with an ACE inhibitor or angiotensin II antagonist (AIIA) for \>5 years
* Patients treated with ACE inhibitor or AIIA therapy for 5 years or less may enter the study provided therapy is discontinued during the 6 week screening period prior to randomization
* History of myocardial infarction (MI) (heart attack) or coronary artery bypass graft (CABG) surgery within the past 1 month
* History of cerebral vascular accident (CVA) (stroke) or percutaneous transluminal coronary angioplasty (PTCA) within the past 6 months
* History of transient ischemic attacks (TIA) within the past year. Patients with unstable angina are excluded until stabilized
* Heart failure requiring ACE inhibitor therapy
* Steroids (oral or parenteral) or immunosuppressives are not permitted. Debilitating psychological illness
* Evidence of significant hepatic (liver) dysfunction: History of allergy to losartan
* Known positive test for HIV or patients known to be hepatitis B or C antigen carriers
* Pregnant or nursing women
* Females of childbearing age must either be surgically sterilized or, if sexually active, using an effective form of contraception and may enter only if an exclusionary pregnancy test is done within approximately 72 hours prior to randomization
* Pregnancy tests will be done every 3 months during the study and at the time of discontinuation
Minimum Eligible Age
31 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Organon and Co
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Arredondo A, Burke TA, Carides GW, Lemus E, Querol J. The impact of losartan on the lifetime incidence of ESRD and costs in Mexico. Rev Invest Clin. 2005 May-Jun;57(3):399-405.
Reference Type
BACKGROUND
Carides GW, Shahinfar S, Dasbach EJ, Keane WF, Gerth WC, Alexander CM, Herman WH, Brenner BM; RENAAL Investigators. The impact of losartan on the lifetime incidence of end-stage renal disease and costs in patients with type 2 diabetes and nephropathy. Pharmacoeconomics. 2006;24(6):549-58. doi: 10.2165/00019053-200624060-00003.
Reference Type
BACKGROUND
Appel GB, Radhakrishnan J, Avram MM, DeFronzo RA, Escobar-Jimenez F, Campos MM, Burgess E, Hille DA, Dickson TZ, Shahinfar S, Brenner BM; RENAAL Study. Analysis of metabolic parameters as predictors of risk in the RENAAL study. Diabetes Care. 2003 May;26(5):1402-7. doi: 10.2337/diacare.26.5.1402.
Reference Type
BACKGROUND
Bakris GL, Weir MR, Shanifar S, Zhang Z, Douglas J, van Dijk DJ, Brenner BM; RENAAL Study Group. Effects of blood pressure level on progression of diabetic nephropathy: results from the RENAAL study. Arch Intern Med. 2003 Jul 14;163(13):1555-65. doi: 10.1001/archinte.163.13.1555.
Reference Type
BACKGROUND
Remuzzi G, Ruggenenti P, Perna A, Dimitrov BD, de Zeeuw D, Hille DA, Shahinfar S, Carides GW, Brenner BM; RENAAL Study Group. Continuum of renoprotection with losartan at all stages of type 2 diabetic nephropathy: a post hoc analysis of the RENAAL trial results. J Am Soc Nephrol. 2004 Dec;15(12):3117-25. doi: 10.1097/01.ASN.0000146423.71226.0C.
Reference Type
BACKGROUND
de Zeeuw D, Ramjit D, Zhang Z, Ribeiro AB, Kurokawa K, Lash JP, Chan J, Remuzzi G, Brenner BM, Shahinfar S. Renal risk and renoprotection among ethnic groups with type 2 diabetic nephropathy: a post hoc analysis of RENAAL. Kidney Int. 2006 May;69(9):1675-82. doi: 10.1038/sj.ki.5000326.
Reference Type
BACKGROUND
Brenner BM, Cooper ME, de Zeeuw D, Keane WF, Mitch WE, Parving HH, Remuzzi G, Snapinn SM, Zhang Z, Shahinfar S; RENAAL Study Investigators. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001 Sep 20;345(12):861-9. doi: 10.1056/NEJMoa011161.
Reference Type
BACKGROUND
de Zeeuw D, Remuzzi G, Parving HH, Keane WF, Zhang Z, Shahinfar S, Snapinn S, Cooper ME, Mitch WE, Brenner BM. Proteinuria, a target for renoprotection in patients with type 2 diabetic nephropathy: lessons from RENAAL. Kidney Int. 2004 Jun;65(6):2309-20. doi: 10.1111/j.1523-1755.2004.00653.x.
Reference Type
BACKGROUND
Mohanram A, Zhang Z, Shahinfar S, Keane WF, Brenner BM, Toto RD. Anemia and end-stage renal disease in patients with type 2 diabetes and nephropathy. Kidney Int. 2004 Sep;66(3):1131-8. doi: 10.1111/j.1523-1755.2004.00863.x.
Reference Type
BACKGROUND
de Zeeuw D, Remuzzi G, Parving HH, Keane WF, Zhang Z, Shahinfar S, Snapinn S, Cooper ME, Mitch WE, Brenner BM. Albuminuria, a therapeutic target for cardiovascular protection in type 2 diabetic patients with nephropathy. Circulation. 2004 Aug 24;110(8):921-7. doi: 10.1161/01.CIR.0000139860.33974.28. Epub 2004 Aug 9.
Reference Type
BACKGROUND
Keane WF, Brenner BM, de Zeeuw D, Grunfeld JP, McGill J, Mitch WE, Ribeiro AB, Shahinfar S, Simpson RL, Snapinn SM, Toto R; RENAAL Study Investigators. The risk of developing end-stage renal disease in patients with type 2 diabetes and nephropathy: the RENAAL study. Kidney Int. 2003 Apr;63(4):1499-507. doi: 10.1046/j.1523-1755.2003.00885.x.
Reference Type
BACKGROUND
Jafar TH, Schmid CH, Stark PC, Toto R, Remuzzi G, Ruggenenti P, Marcantoni C, Becker G, Shahinfar S, De Jong PE, De Zeeuw D, Kamper AL, Strangaard S, Levey AS. The rate of progression of renal disease may not be slower in women compared with men: a patient-level meta-analysis. Nephrol Dial Transplant. 2003 Oct;18(10):2047-53. doi: 10.1093/ndt/gfg317.
Reference Type
BACKGROUND
Herman WH, Shahinfar S, Carides GW, Dasbach EJ, Gerth WC, Alexander CM, Cook JR, Keane WF, Brenner BM. Losartan reduces the costs associated with diabetic end-stage renal disease: the RENAAL study economic evaluation. Diabetes Care. 2003 Mar;26(3):683-7. doi: 10.2337/diacare.26.3.683.
Reference Type
BACKGROUND
Eijkelkamp WB, Zhang Z, Remuzzi G, Parving HH, Cooper ME, Keane WF, Shahinfar S, Gleim GW, Weir MR, Brenner BM, de Zeeuw D. Albuminuria is a target for renoprotective therapy independent from blood pressure in patients with type 2 diabetic nephropathy: post hoc analysis from the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) trial. J Am Soc Nephrol. 2007 May;18(5):1540-6. doi: 10.1681/ASN.2006050445. Epub 2007 Apr 4.
Reference Type
BACKGROUND
Eijkelkamp WB, Zhang Z, Brenner BM, Cooper ME, Devereux RB, Dahlof B, Ibsen H, Keane WF, Lindholm LH, Olsen MH, Parving HH, Remuzzi G, Shahinfar S, Snapinn SM, Wachtell K, de Zeeuw D. Renal function and risk for cardiovascular events in type 2 diabetic patients with hypertension: the RENAAL and LIFE studies. J Hypertens. 2007 Apr;25(4):871-6. doi: 10.1097/HJH.0b013e328014953c.
Reference Type
BACKGROUND
Keane WF, Zhang Z, Lyle PA, Cooper ME, de Zeeuw D, Grunfeld JP, Lash JP, McGill JB, Mitch WE, Remuzzi G, Shahinfar S, Snapinn SM, Toto R, Brenner BM; RENAAL Study Investigators. Risk scores for predicting outcomes in patients with type 2 diabetes and nephropathy: the RENAAL study. Clin J Am Soc Nephrol. 2006 Jul;1(4):761-7. doi: 10.2215/CJN.01381005. Epub 2006 May 17.
Reference Type
BACKGROUND
Mohanram A, Zhang Z, Shahinfar S, Lyle PA, Toto RD. The effect of losartan on hemoglobin concentration and renal outcome in diabetic nephropathy of type 2 diabetes. Kidney Int. 2008 Mar;73(5):630-6. doi: 10.1038/sj.ki.5002746. Epub 2007 Dec 19.
Reference Type
BACKGROUND
Parving HH, de Zeeuw D, Cooper ME, Remuzzi G, Liu N, Lunceford J, Shahinfar S, Wong PH, Lyle PA, Rossing P, Brenner BM. ACE gene polymorphism and losartan treatment in type 2 diabetic patients with nephropathy. J Am Soc Nephrol. 2008 Apr;19(4):771-9. doi: 10.1681/ASN.2007050582. Epub 2008 Jan 16.
Reference Type
BACKGROUND
Tershakovec AM, Keane WF, Zhang Z, Lyle PA, Appel GB, McGill JB, Parving HH, Cooper ME, Shahinfar S, Brenner BM. Effect of LDL cholesterol and treatment with losartan on end-stage renal disease in the RENAAL study. Diabetes Care. 2008 Mar;31(3):445-7. doi: 10.2337/dc07-0196. Epub 2007 Dec 10.
Reference Type
BACKGROUND
Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Jun 17. doi: 10.1681/ASN.0000000766. Online ahead of print. No abstract available.
Reference Type
DERIVED
de Vries ST, Pena MJ, Tye SC, Peters SAE, van Raalte DH, Arnott C, Voors AA, Mol PGM, Denig P, Heerspink HJL. Sex differences in the efficacy of angiotensin receptor blockers on kidney and cardiovascular outcomes among individuals with type 2 diabetes and diabetic kidney disease: post hoc analyses of the RENAAL and IDNT trials. Diabetologia. 2025 Mar;68(3):507-515. doi: 10.1007/s00125-024-06325-y. Epub 2024 Dec 10.
Reference Type
DERIVED
Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.
Reference Type
DERIVED
Heerspink HJL, Jongs N, Schloemer P, Little DJ, Brinker M, Tasto C, Karpefors M, Wheeler DC, Bakris G, Perkovic V, Nkulikiyinka R, Rossert J, Gasparyan SB. Development and Validation of a New Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression. J Am Soc Nephrol. 2023 Dec 1;34(12):2025-2038. doi: 10.1681/ASN.0000000000000243. Epub 2023 Oct 24.
Reference Type
DERIVED
Miao Y, Ottenbros SA, Laverman GD, Brenner BM, Cooper ME, Parving HH, Grobbee DE, Shahinfar S, de Zeeuw D, Lambers Heerspink HJ. Effect of a reduction in uric acid on renal outcomes during losartan treatment: a post hoc analysis of the reduction of endpoints in non-insulin-dependent diabetes mellitus with the Angiotensin II Antagonist Losartan Trial. Hypertension. 2011 Jul;58(1):2-7. doi: 10.1161/HYPERTENSIONAHA.111.171488. Epub 2011 May 31.
Reference Type
DERIVED
Other Identifiers
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2006_020
Identifier Type: -
Identifier Source: secondary_id
0954-147
Identifier Type: -
Identifier Source: org_study_id
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