Safety and Efficacy of Two Year of RAAS Alone or in Combination With Spironolactone Therapy (MRA-ACE)

  • STATUS
    Recruiting
  • End date
    Oct 1, 2023
  • participants needed
    72
  • sponsor
    James A. Tumlin, MD
Updated on 23 March 2022
diabetes
renal function
hypertension
type 2 diabetes mellitus
angiotensin
antihypertensive drugs
proteinuria

Summary

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.

Details
Condition Renal Insufficiency, Chronic, Diabetic Nephropathy Type 2
Treatment ACE inhibitor, ARB, Renin-Angiotensin (RAAS) bers (ACE/ARB) alone, Renin-Angiotensin (RAAS) blockers in combination with Spironolactone, Renin-Angiotensin (RAAS) alone
Clinical Study IdentifierNCT03502031
SponsorJames A. Tumlin, MD
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age above 18
Male or Female
Patients with Type II diabetes mellitus must be receiving oral agents or insulin injections at the time of randomization
All eligible patients will be on a stable, maximum to dose of an ACE or ARB for 2 weeks prior to randomization
Note: The determination of m tolerated ACE-ARB therapy will be left to the discretion of 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 to the time of randomization
ACE or ARB therapy will be the primary antihypertensive therapy used for blood pressure control and will be titrthe highest tolerated dose to achieve a target blood pressure of <Patients requiring additional medications to achieve the target blood pressure will use antihypertensive agents that have neutral effects on urinary proteinuria (e.g. Hydralazine or lo Dihydropyridine calcium channel blockers etc.). CcThe final choice of additional medications will be left to the discretion of the site principal investigator (PI)
Patients with anurine protein to creatinine (UP/Cr) ratio that is mg/gm from the average of two historical value within one year prior to randomization will be considered eligible for study entry
Patients with a baseline K+ of >5\. X5 meq/l on maximum tolerated ACE-ARB therapy during the screening period can be treated with 8.4 grams of Patiromer for 7 days. If at the end of 7days the serum K+ is < 5.0 meq/liter the patient will be considered eligible to participate in the study. If at the end of 7 days the serum K+ >5.0 meq/l the dose of Patiromer can be increased to 16.8 grams. If at the end of 7 days the serum K+ is < 5.0 meq/L, the patient will be considered eligible for study entry. If after 7 days at the higher dose of Patiromer the serum K+ >5.0, the patient will be ineligible 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 or are 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 study randomization
Concurrent use of Amiloride, , Aliskerin, or other Aldosterone antagonists Patien receiving any of the above medications will be considered eligible for study participation after a wash-out
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