Effects of Spironolactone Combination Therapy on Proteinuria, Kidney Function, and Blood Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alireza Esteghamati, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01667614
First received: August 15, 2012
Last updated: August 27, 2012
Last verified: August 2012

August 15, 2012
August 27, 2012
May 2010
March 2012   (final data collection date for primary outcome measure)
Urinary albumin excretion [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Urinary albumin excretion assessed by overnight (12 hour) collection of urine. Measured at baseline, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month.
Same as current
Complete list of historical versions of study NCT01667614 on ClinicalTrials.gov Archive Site
  • estimated glomerular filtration rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    estimated glomerular filtration rate calculated using the formula developed by Chronic Kidney Disease Epidemiology Collaboration. Measured at baseline, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month.
  • Blood pressure [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Systolic and diastolic blood pressure assessed by mercury sphygnomanometry. Patients were placed in a sitting position and after ten minutes rest, two readings from right-side hand with five minutes interval were obtained. Measured at baseline, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month.
  • serum creatinine concentrations [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    serum creatinine concentrations assessed by Jaffe method. Measured at baseline, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month.
  • Serum potassium concentrations [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Serum potassium concentrations measured at baseline, 1st month, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month.
Same as current
Not Provided
Not Provided
 
Effects of Spironolactone Combination Therapy on Proteinuria, Kidney Function, and Blood Pressure
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Diabetic Nephropathy
  • Essential Hypertension
Drug: spironolacone 25 mg tablets added to losartan
spironolactone 25 mg once daily added to losartan
  • No Intervention: ACE/ARB
    In 62 patients previously treated with enalapril (10-30 mg daily) + losartan (50-100 mg daily), this regimen was continued.
  • Active Comparator: Spironolactone/ARB
    spironolacone 25 mg tablets added to losartan
    Intervention: Drug: spironolacone 25 mg tablets added to losartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
July 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01667614
90-2-27-16-10
No
Alireza Esteghamati, Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
Principal Investigator: Alireza Esteghamati, M.D. Tehran University of Medical Sciences
Tehran University of Medical Sciences
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP