NephroNet proposes to examine whether combining Spironolactone with maximal RAAS blockade will further reduce urinary protein at one year and whether prolonged therapy (24 months) is able to slow the decline in GFR. Because of combination MRA and RAAS therapy significantly increases the risk for clinically significant hyperkalemia, we also plan to determine whether the addition of Patiromer to these patients facilitates the use of combination therapy and allows a larger proportion of diabetic patients the potential benefit of combination therapy on renal function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
maximal RAAS blockade alone for 24months.
maximal RAAS blockade alone or in combination with Spironolactone (25 mg) for 24 months.
Georgia Nephrology Research Institute
Lawrenceville, Georgia, United States
RECRUITINGNelson Kopyt, MD
Bethlehem, Pennsylvania, United States
RECRUITINGCombination Therapy - RAAS inhibition and Spironolactone to lower UP/Cr
To determine whether combination therapy with maximall RAAS inhibition and Spironolactone is superior to RAAS inhibition alone in lowering the UP/Cr ratio at 12 months
Time frame: 24 months
Combination Therapy - RAAS inhibition and Spironolactone
To determine whether combination therapy with maximally tolerated RAAS inhibition and Spironolactone is superior to RAAS inhibition alone in slowing the progression of renal disease as evidenced by changes in GFR
Time frame: 24 months
Combination Therapy - RAAS inhibition and Spironolactone that develop hyperkalemia
To determine the patients in the maximal RAAS blockade group and those receiving combination RAAS + Spironolactone therapy developing clinically significant hyperkalemia as defined as a serum K+ level greater than 5.5 meq/L. We will determine the percentage of patients that require "Patiromer-Rescue" for K+ \> 5.5 meq/L and the percentage of patients maintained with serum K+ less than 5.5 meq/L
Time frame: 12 months, 24 months
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