DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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 rate

Blood pressure

serum creatinine concentrations

Serum potassium concentrations


Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.


Inclusion Criteria:

- type 2 diabetes patients with diabetic nephropathy in the range of micro- or


- 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


- 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017