Salt Intake and Antiproteinuric Effect of Paricalcitol in Type 2 Diabetes
Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
Summary
Proteinuria is an independent risk factor for cardiovascular morbidity and mortality and for
renal disease progression. More proteinuria is associated with faster progression, whereas
treatments that reduce proteinuria are renoprotective in both diabetic and non diabetic
chronic kidney disease. Of note, lower the residual proteinuria achieved by treatment slower
is the disease progression in the long term. On the basis of the above findings, proteinuria
has become a target of renoprotective therapy.
Among different antihypertensive medications, those that inhibit the Renin Angiotensin
System, such as angiotensin converting enzyme (ACE)inhibitors and angiotensin receptor
blockers (ARBs), are those that at comparable blood pressure control, more effectively reduce
proteinuria and slow renal disease progression. Thus they have become the key component of
renoprotective therapy in patients with proteinuric chronic kidney disease. Observational
studies found that their effectiveness, however, is limited or even fully blunted in patients
who eat large amount of salt.
Experimental evidence indicates a renoprotective role of the vitamin D system in chronic
renal disease. A recent randomized, controlled trial, add-on therapy with selective Vitamin D
receptor activator paricalcitol showed an additive antiproteinuric effect in subjects with
type 2 diabetes and chronic kidney disease on background Renin-angiotensin-system inhibitor
therapy. This effect, however, was largely restricted to subjects with daily sodium intake
exceeding 12 grams and was negligible in those with lower sodium intake. Thus, treatment with
paricalcitol appears to be effective in particular in those patients who do not appreciably
benefit of renin angiotensin system (RAS) inhibitors therapy because of high salt intake.
Thus, whether the antiproteinuric effect of paricalcitol is modified by concomitant salt
intake in patients with chronic kidney disease (CKD) on background RAS inhibitors therapy, is
worth investigating.
The broad aim of this study is to evaluate the interaction between paricalcitol therapy and
sodium intake in type 2 diabetes patients with proteinuric kidney disease on stable
background RAS inhibitor therapy.
Phase:
Phase 2
Details
Lead Sponsor:
Mario Negri Institute for Pharmacological Research