The losartan renal protection study - Rationale, study design and baseline characteristics of RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan)

Barry M. Brenner, Mark E. Cooper, Dick De Zeeuw, Jean Pierre Grunfeld, William F. Keane, Kiyoshi Kurokawa, Janet B. McGill, William E. Mitch, Hans Henrik Parving, Guiseppe Remuzzi, Arthur B. Ribeiro, Mark D. Schluchter, Duane Snavely, Zhongxin Zhang, Roger Simpson, Denise Ramjit, Shahnaz Shahinfar

Research output: Contribution to journalArticle

111 Citations (Scopus)

Abstract

The RENAAL Study is a double-blind, placebo-controlled trial to evaluate the renal protective effects of losartan in Type 2 diabetic patients with nephropathy. The study has enrolled 1513 patients and is expected to continue for 3.5 years after the last patient has been entered. Eligible patients must have a urinary albumin:creatinine ratio of at least 300 mg/g and serum creatinine between 1.3 to 3.0 mg/dL. Eligible hypertensive or normotensive patients are randomised to receive either losartan or placebo, in addition to their existing antihypertensive therapy. Medications that block angiotensin production or action, are excluded. The primary endpoint is a composite of the time to first event of doubling of serum creatinine, end-stage renal disease, or death; secondary endpoints include cardiovascular events, progression of renal disease, and changes in proteinuria; tertiary endpoints include quality of life, healthcare resource utilisation, and amputations. Patients include Caucasians (48.6%), Blacks (15.2%), Asians (16.7%), and Hispanics (18.2%). Baseline urinary albumin:creatinine ratio and serum creatinine levels average 1867 mg/g and 1.9 mg/dL, respectively. Mean systolic and diastolic blood pressures are 153 and 82 mmHg, respectively. RENAAL will document whether blockade of the AII receptor with losartan produces clinical benefits in patients with Type 2 diabetes and nephropathy.

Original languageEnglish
Pages (from-to)328-335
Number of pages8
JournalJRAAS - Journal of the Renin-Angiotensin-Aldosterone System
Volume1
Issue number4
Publication statusPublished - Dec 2000

Fingerprint

Losartan
Angiotensin II
Type 2 Diabetes Mellitus
Kidney
Creatinine
Albumins
Serum
Placebos
Blood Pressure
Quality of Health Care
Angiotensins
Amputation
Proteinuria
Hispanic Americans
Antihypertensive Agents
Chronic Kidney Failure
Disease Progression
Quality of Life

Keywords

  • Angiotensin II receptor antagonist
  • Creatinine clearance
  • End-stage renal disease
  • Losartan
  • Non-insulin dependent diabetes mellitus
  • Proteinuria

ASJC Scopus subject areas

  • Endocrinology
  • Internal Medicine

Cite this

The losartan renal protection study - Rationale, study design and baseline characteristics of RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan). / Brenner, Barry M.; Cooper, Mark E.; De Zeeuw, Dick; Grunfeld, Jean Pierre; Keane, William F.; Kurokawa, Kiyoshi; McGill, Janet B.; Mitch, William E.; Parving, Hans Henrik; Remuzzi, Guiseppe; Ribeiro, Arthur B.; Schluchter, Mark D.; Snavely, Duane; Zhang, Zhongxin; Simpson, Roger; Ramjit, Denise; Shahinfar, Shahnaz.

In: JRAAS - Journal of the Renin-Angiotensin-Aldosterone System, Vol. 1, No. 4, 12.2000, p. 328-335.

Research output: Contribution to journalArticle

Brenner, BM, Cooper, ME, De Zeeuw, D, Grunfeld, JP, Keane, WF, Kurokawa, K, McGill, JB, Mitch, WE, Parving, HH, Remuzzi, G, Ribeiro, AB, Schluchter, MD, Snavely, D, Zhang, Z, Simpson, R, Ramjit, D & Shahinfar, S 2000, 'The losartan renal protection study - Rationale, study design and baseline characteristics of RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan)', JRAAS - Journal of the Renin-Angiotensin-Aldosterone System, vol. 1, no. 4, pp. 328-335.
Brenner, Barry M. ; Cooper, Mark E. ; De Zeeuw, Dick ; Grunfeld, Jean Pierre ; Keane, William F. ; Kurokawa, Kiyoshi ; McGill, Janet B. ; Mitch, William E. ; Parving, Hans Henrik ; Remuzzi, Guiseppe ; Ribeiro, Arthur B. ; Schluchter, Mark D. ; Snavely, Duane ; Zhang, Zhongxin ; Simpson, Roger ; Ramjit, Denise ; Shahinfar, Shahnaz. / The losartan renal protection study - Rationale, study design and baseline characteristics of RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan). In: JRAAS - Journal of the Renin-Angiotensin-Aldosterone System. 2000 ; Vol. 1, No. 4. pp. 328-335.
@article{fe1d062541e044059978a695bf1a5823,
title = "The losartan renal protection study - Rationale, study design and baseline characteristics of RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan)",
abstract = "The RENAAL Study is a double-blind, placebo-controlled trial to evaluate the renal protective effects of losartan in Type 2 diabetic patients with nephropathy. The study has enrolled 1513 patients and is expected to continue for 3.5 years after the last patient has been entered. Eligible patients must have a urinary albumin:creatinine ratio of at least 300 mg/g and serum creatinine between 1.3 to 3.0 mg/dL. Eligible hypertensive or normotensive patients are randomised to receive either losartan or placebo, in addition to their existing antihypertensive therapy. Medications that block angiotensin production or action, are excluded. The primary endpoint is a composite of the time to first event of doubling of serum creatinine, end-stage renal disease, or death; secondary endpoints include cardiovascular events, progression of renal disease, and changes in proteinuria; tertiary endpoints include quality of life, healthcare resource utilisation, and amputations. Patients include Caucasians (48.6{\%}), Blacks (15.2{\%}), Asians (16.7{\%}), and Hispanics (18.2{\%}). Baseline urinary albumin:creatinine ratio and serum creatinine levels average 1867 mg/g and 1.9 mg/dL, respectively. Mean systolic and diastolic blood pressures are 153 and 82 mmHg, respectively. RENAAL will document whether blockade of the AII receptor with losartan produces clinical benefits in patients with Type 2 diabetes and nephropathy.",
keywords = "Angiotensin II receptor antagonist, Creatinine clearance, End-stage renal disease, Losartan, Non-insulin dependent diabetes mellitus, Proteinuria",
author = "Brenner, {Barry M.} and Cooper, {Mark E.} and {De Zeeuw}, Dick and Grunfeld, {Jean Pierre} and Keane, {William F.} and Kiyoshi Kurokawa and McGill, {Janet B.} and Mitch, {William E.} and Parving, {Hans Henrik} and Guiseppe Remuzzi and Ribeiro, {Arthur B.} and Schluchter, {Mark D.} and Duane Snavely and Zhongxin Zhang and Roger Simpson and Denise Ramjit and Shahnaz Shahinfar",
year = "2000",
month = "12",
language = "English",
volume = "1",
pages = "328--335",
journal = "JRAAS - Journal of the Renin-Angiotensin-Aldosterone System",
issn = "1470-3203",
publisher = "SAGE Publications Ltd",
number = "4",

}

TY - JOUR

T1 - The losartan renal protection study - Rationale, study design and baseline characteristics of RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan)

AU - Brenner, Barry M.

AU - Cooper, Mark E.

AU - De Zeeuw, Dick

AU - Grunfeld, Jean Pierre

AU - Keane, William F.

AU - Kurokawa, Kiyoshi

AU - McGill, Janet B.

AU - Mitch, William E.

AU - Parving, Hans Henrik

AU - Remuzzi, Guiseppe

AU - Ribeiro, Arthur B.

AU - Schluchter, Mark D.

AU - Snavely, Duane

AU - Zhang, Zhongxin

AU - Simpson, Roger

AU - Ramjit, Denise

AU - Shahinfar, Shahnaz

PY - 2000/12

Y1 - 2000/12

N2 - The RENAAL Study is a double-blind, placebo-controlled trial to evaluate the renal protective effects of losartan in Type 2 diabetic patients with nephropathy. The study has enrolled 1513 patients and is expected to continue for 3.5 years after the last patient has been entered. Eligible patients must have a urinary albumin:creatinine ratio of at least 300 mg/g and serum creatinine between 1.3 to 3.0 mg/dL. Eligible hypertensive or normotensive patients are randomised to receive either losartan or placebo, in addition to their existing antihypertensive therapy. Medications that block angiotensin production or action, are excluded. The primary endpoint is a composite of the time to first event of doubling of serum creatinine, end-stage renal disease, or death; secondary endpoints include cardiovascular events, progression of renal disease, and changes in proteinuria; tertiary endpoints include quality of life, healthcare resource utilisation, and amputations. Patients include Caucasians (48.6%), Blacks (15.2%), Asians (16.7%), and Hispanics (18.2%). Baseline urinary albumin:creatinine ratio and serum creatinine levels average 1867 mg/g and 1.9 mg/dL, respectively. Mean systolic and diastolic blood pressures are 153 and 82 mmHg, respectively. RENAAL will document whether blockade of the AII receptor with losartan produces clinical benefits in patients with Type 2 diabetes and nephropathy.

AB - The RENAAL Study is a double-blind, placebo-controlled trial to evaluate the renal protective effects of losartan in Type 2 diabetic patients with nephropathy. The study has enrolled 1513 patients and is expected to continue for 3.5 years after the last patient has been entered. Eligible patients must have a urinary albumin:creatinine ratio of at least 300 mg/g and serum creatinine between 1.3 to 3.0 mg/dL. Eligible hypertensive or normotensive patients are randomised to receive either losartan or placebo, in addition to their existing antihypertensive therapy. Medications that block angiotensin production or action, are excluded. The primary endpoint is a composite of the time to first event of doubling of serum creatinine, end-stage renal disease, or death; secondary endpoints include cardiovascular events, progression of renal disease, and changes in proteinuria; tertiary endpoints include quality of life, healthcare resource utilisation, and amputations. Patients include Caucasians (48.6%), Blacks (15.2%), Asians (16.7%), and Hispanics (18.2%). Baseline urinary albumin:creatinine ratio and serum creatinine levels average 1867 mg/g and 1.9 mg/dL, respectively. Mean systolic and diastolic blood pressures are 153 and 82 mmHg, respectively. RENAAL will document whether blockade of the AII receptor with losartan produces clinical benefits in patients with Type 2 diabetes and nephropathy.

KW - Angiotensin II receptor antagonist

KW - Creatinine clearance

KW - End-stage renal disease

KW - Losartan

KW - Non-insulin dependent diabetes mellitus

KW - Proteinuria

UR - http://www.scopus.com/inward/record.url?scp=0034585310&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0034585310&partnerID=8YFLogxK

M3 - Article

C2 - 11967819

AN - SCOPUS:0034585310

VL - 1

SP - 328

EP - 335

JO - JRAAS - Journal of the Renin-Angiotensin-Aldosterone System

JF - JRAAS - Journal of the Renin-Angiotensin-Aldosterone System

SN - 1470-3203

IS - 4

ER -