Effects of Spironolactone Combination Therapy on Proteinuria, Kidney Function, and Blood Pressure
Information source: Tehran University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus; Diabetic Nephropathy; Essential Hypertension
Intervention: spironolacone 25 mg tablets added to losartan (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Tehran University of Medical Sciences Official(s) and/or principal investigator(s): Alireza Esteghamati, M.D., Principal Investigator, Affiliation: Tehran University of Medical Sciences
Summary
The detrimental effects of aldostrone are not adequately arrested by the use of angiotensin
converting enzyme (ACE), angiotensin II receptor blocker (ARB) or a combination of both.
Recent evidence has provided robust evidence that aldostrone escape plays an important role
in this regard. It is believed that aldostrone escape occurs quite commonly with reports
indicating prevalence rates as high as 22% with ARBs and 40% with ACE inhibitors. In a trial
of patients with diabetes and hypertension it was shown that treatment of aldostrone escape
with spironolactone 25 mg daily for three months significantly reduces proteinuria. A number
of other trials have similarly observed that addition of spironolactone to an ACE inhibitor
based regimen provides additional benefits on proteinuria reduction, blood pressure control,
and prevention of glomerular filtration rate (GFR) decline. Most of the available trials in
this regard are of short duration (e. g. three months), and have added spironolactone to an
ACE or ACE+ARB based regimen (the so-called triple blockade). Currently, evidence evaluating
efficacy of a combined ARB+spironolactone regimen compared with conventional double RAS
blockade (i. e. ACE+ARB) is lacking. Hence, this randomized open label trial was initiated to
determine the effects of addition of spironolactone 25 mg daily to losartan over a period of
18 months.
Clinical Details
Official title: Comparison of Efficacy of Losartan/Spironolactone and Losartan/Enalapril on Urinary Albumin Excretion, Estimated Glomerular Filtration Rate, and Blood Pressure in Patients With Type 2 Diabetes Nephropathy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Urinary albumin excretion
Secondary outcome: estimated glomerular filtration rateBlood pressure serum creatinine concentrations Serum potassium concentrations
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- type 2 diabetes patients with diabetic nephropathy in the range of micro- or
macroalbuminuria
- treatment with combination of enalapril and losartan for more than one year
Exclusion Criteria:
- history of non-adherence to prescribed medication assessed by the prescribing
physician
- baseline potassium > 5. 5 meq/L
- chronic kidney disease stages 4 or 5
- history or evidence of non-diabetic kidney disease
Locations and Contacts
Tehran University of Medical Sciences, Vali-asr hospital, Endocrinology and Metabolism Research Center, Tehran 13145-784, Iran, Islamic Republic of
Additional Information
Starting date: May 2010
Last updated: August 27, 2012
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