Can albuminuria reduction improve cardiovascular and renal health?
Study Acronym:CLARITY trial
Hypothesis: Reduction in urinary albumin by escalating dosages of an ARB or by combination therapy of ARB plus eplerenone can reduce residual renal and cardiovascular risk associated with ongoing albuminuria in patients with type 2 diabetes mellitus.
Inclusion criteria: Patients > 18 years old with type 2 diabetes mellitus on either an ACE inhibitor or ARB with a PCR of 500 mg/g to 1000 mg/g at enrollment.
Design: Patients with proteinuria between 500 mg and 1g per day and GFR 45-60 ml/min will be randomized in open-label fashion to 1 of 2 groups.
- “Usual care”, using patients’ enrollment ACE inhibitor or ARB. Blood pressure is maintained <130/80 by any means except by increasing ACE or ARB.
- Escalation of patient’s enrollment ACE or ARB by forced titration until PCR falls to the 200 or less or until it does not respond to 2 consecutive titrations. The physician may optionally add eplerenone to attempt further reduction in albuminuria. In order to prevent hyperkalemia as a cause for withdrawal from the study, all patients are prescribed the potassium binder Patiromer. Additional medications other than ACE inhibitors, ARBs or aldosterone blockers may be added to maintain BP <130/80.
Follow-up: Patients continued on study protocol for 5 years
Primary Outcomes: Doubling of serum creatinine, ESRD or death
Secondly Outcomes: Composite of myocardial infarction, coronary revascularization, sudden death or stroke