Single-center, Open-label, Randomized Study of Anemia Management Improvement in End Stage Renal Disease (ESRD) Patients With Secondary Hyperparathyroidism (OPTIMAL)

NCT02273570 NA UNKNOWN

Clinical study aimed at improving anemia management in End Stage Renal Disease Patient (ESRD) on maintenance Hemodialysis with evidence of Chronic Kidney disease Mineral Bone Disorder (CKD-MBD)

Details

Lead sponsor	Azienda Ospedaliera Sant'Anna
Phase	NA
Status	UNKNOWN
Enrolment	50
Start date	2015-03
Completion	2017-03

Conditions

• Hyperparathyroidism, Secondary

Interventions

• standard care
• Optimal (I. iPTH control: Zemplar®,Mimpara®; phosphorous control: Renvela®, Phoslo®, Osvaren®, Foznol®,Maalox®; calcium control: calcium and vitamin D

Primary outcomes

• percent reduction in weekly ESA consumption to maintain Hb levels within the recommended range 10.0-11.5 g/dl — baseline and after 12 months of followup
  Primary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with a lower ESA dose use to achieve the target Hb of 10.0-11.5 g/dl

Countries

Italy