Effects of Spironolactone Combination Therapy on Proteinuria, Kidney Function, and Blood Pressure
|ClinicalTrials.gov Identifier: NCT01667614|
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : August 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Diabetic Nephropathy Essential Hypertension||Drug: spironolacone 25 mg tablets added to losartan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||July 2012|
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
Drug: spironolacone 25 mg tablets added to losartan
spironolactone 25 mg once daily added to losartan
- Urinary albumin excretion [ Time Frame: 18 months ]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.
- estimated glomerular filtration rate [ Time Frame: 18 months ]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 ]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 ]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 ]Serum potassium concentrations measured at baseline, 1st month, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667614
|Iran, Islamic Republic of|
|Tehran University of Medical Sciences, Vali-asr hospital, Endocrinology and Metabolism Research Center|
|Tehran, Iran, Islamic Republic of, 13145-784|
|Principal Investigator:||Alireza Esteghamati, M.D.||Tehran University of Medical Sciences|