Moderate salt restriction with or without paricalcitol in type 2 diabetes and losartan-resistant macroalbuminuria (PROCEED): a randomised, double-blind, placebo-controlled, crossover trial

Crossover RCT (n=115) found that moderate salt restriction reduced albinuria by 36.6% in patients taking losartan. Use of paricalcitol 2 micrograms per day reduced albinuria in those on a high salt intake, but not in those on a moderate salt restricted diet.

During paricalcitol therapy, 14 cases of hypercalciuria, six cases of hypercalcaemia, and five cases of hyperphosphataemia were reported in one patient each, all of which were possibly treatment related.

 

Paricalcitol is licensed in adult patients for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal insufficiency

 

A related commentary reviews this research.  Given the absence of evidence of long-term preservation of renal function by paricalcitol and the potential safety signal of the 2 microgram per day dose, this dose should not be used to reduce albuminuria outside of a clinical trial context. Prospective registries should be used to assess the cardiovascular and renal safety of this dose of paricalcitol when used for other indications.