Safety and Efficacy of Two Year of RAAS Alone or in Combination With Spironolactone Therapy

Inclusion Criteria:

• Age above 18
• Male or Female
• Patients with Type II diabetes mellitus must be receiving oral agents or insulininjections at the time of randomization
• All eligible patients will be on a stable, maximum to dose of an ACE or ARB for 2weeks prior to randomization.
• Note: The determination of m tolerated ACE-ARB therapy will be left to the discretionof the site princ
• All eligible patientswill have hypertension targetblood pressur of < 140/90mm Hg.
• Antihypertensiv therapy may be adjusted to achieve the target blood pressure prior tothe time of randomization.
• ACE or ARB therapy will be the primary antihypertensive therapy used for bloodpressure control and will be titrthe highest tolerated dose to achieve a target bloodpressure of <Patients requiring additional medications to achieve the target bloodpressure will use antihypertensive agents that have neutral effects on urinaryproteinuria (e.g. Hydralazine or lo Dihydropyridine calcium channel blockers etc.).CcThe final choice of additional medications will be left to the discretion of thesite principal investigator (PI)
• Patients with anurine protein to creatinine (UP/Cr) ratio that is mg/gm from theaverage of two historical value within one year prior to randomization will beconsidered eligible for study entry.
• Patients with a baseline K+ of >5. X5 meq/l on maximum tolerated ACE-ARB therapyduring the screening period can be treated with 8.4 grams of Patiromer for 7 days. Ifat the end of 7days the serum K+ is < 5.0 meq/liter the patient will be consideredeligible to participate in the study. If at the end of 7 days the serum K+ >5.0 meq/lthe dose of Patiromer can be increased to 16.8 grams. If at the end of 7 days theserum K+ is < 5.0 meq/L, the patient will be considered eligible for study entry. Ifafter 7 days at the higher dose of Patiromer the serum K+ >5.0, the patient will beineligible for study participation.
• Patients with an estimated GFR by CK-Epi .73 m2
• Female patients will be required to undergo routine birth control measures

Exclusion criteria:

• Estimated GFR by MDRD20 mls/min/1.73 M2 using the CKD-Epi equation
• Patients with serum K+ > 5.00 while taking 16.8/day of Patiromer
• Patients with history of Type mellitus
• Patients with HgbA
• Pregnant or breast-feeding female patients
• Female patients unwilling to receive estrogen or progesterone based birth control orare unwilling or unable to usconventional barrier birth control methods.
• Patients with known allergy or intolerance tor Spironolactone therapy
• Patients taking oral or IV digoxin
• Patients receiving chronic steroids > 1oral Prednisone
• Patient that do nohave minimum o eGFR determinations within 2 years prior to studyrandomization
• Concurrent use of Amiloride, , Aliskerin, or other Aldosterone antagonists Patienreceiving any of the above medications will be considered eligible for studyparticipation after a wash-out