STUDY DESIGN
Renin Inhibition and the Kidney
This study was designed to examine the renal and ocular response to Aliskiren in diabetic subjects both acutely, in response to the first dose, and after a new steady state in 14 days. The comparison agent will be the angiotensin II receptor blocker (ARB), Irbesartan, also administered in a dose of 300 mg/day.
Over a two-week period, patients with Type II Diabetes Mellitus visited the inpatient study unit at Brigham and Women’s Hospital. Patients taking ACE inhibitors, angiotensin receptor blockers, mineralocorticoid receptor antagonists, renin inhibitors and diuretics were asked to discontinue these medications for 10 days prior to study start. Each patient followed a high sodium diet prior to admission and all meals were provided to them as part of the study. Over a 6 hour period, measurement of kidney blood flow was completed and patients received a single dose of Captopril. The following day, patients received either Aliskiren or Irbesartan and the same kidney blood flow measurements were performed.
At discharge, patients received a 2 week supply of either Aliskiren or Irbesartan to take at home while also monitoring their blood pressure.
Patients received opthalmic exams performed by the Schepens Retina Associates Foundation (SRAF) staff at Brigham and Women’s Hospital as well as a retinal blood flow exam. These exams were used to study the ocular response to aliskiren and irbesartan.
For more information about this study, please visit: ClinicalTrials.gov
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STUDY DESIGN
This study was designed to examine the renal and ocular response to Aliskiren in diabetic subjects both acutely, in response to the first dose, and after a new steady state in 14 days
Comparison Agents
300 mg/day of angiotensin II receptor blocker (ARB), Irbesartan
300 mg/day of renin inhibitor, Aliskiren
Over a two-week period, patients with Type II Diabetes Mellitus visited the inpatient study unit at Brigham and Women’s Hospital. Patients taking ACE inhibitors, angiotensin receptor blockers, mineralocorticoid receptor antagonists, renin inhibitors and diuretics were asked to discontinue these medications for 10 days prior to study start. Each patient followed a high sodium diet prior to admission and all meals were provided to them as part of the study. Over a 6 hour period, measurement of kidney blood flow was completed and patients received a single dose of Captopril. The following day, patients received either Aliskiren or Irbesartan and the same kidney blood flow measurements were performed.
At discharge, patients received a 2 week supply of either Aliskiren or Irbesartan to take at home while also monitoring their blood pressure.
Patients received opthalmic exams performed by the Schepens Retina Associates Foundation (SRAF) staff at Brigham and Women’s Hospital as well as a retinal blood flow exam. These exams were used to study the ocular response to aliskiren and irbesartan.
For more information about this study, please visit: ClinicalTrials.gov