NCT00977080

Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D

The IMPACT SHPT Study: Study to Evaluate the Improved Management of iPTH With Paricalcitol-centered Therapy vs. Cinacalcet Therapy With Low-dose Vitamin D in Hemodialysis Patients With Secondary Hyperparathyroidism

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.

Detailed description

During a 4-week washout period, participants stopped taking cinacalcet or other vitamin D receptor activators (VDRAs). (Participants who were naive to cinacalcet or VDRAs did not have to wash out). At randomization, participants entered a 28-week open-label treatment period, during which they received either cinacalcet or paricalcitol. Participants who were assigned to receive paricalcitol were dosed according to the approved label in their respective geographic regions (i.e., IV at sites in the US and Russia and oral at sites in Europe). Supplemental cinacalcet was administered to participants in the paricalcitol arms who developed hypercalcemia (defined as \>= 10.5 mg/dL). The evaluation period was from Weeks 21 to 28.

Conditions

• Chronic Kidney Disease
• Secondary Hyperparathyroidism
• Hemodialysis

Interventions

Type	Name	Description
DRUG	Paricalcitol	Paricalcitol dosed per label by region (participants were to receive cinacalcet if they developed hypercalcemia)
DRUG	Cinacalcet	On-label oral cinacalcet by region with low dose vitamin D receptor activator (VDRA) (either doxercalciferol at US sites or alfacalcidol at non-US sites)

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-09-15
• Last updated: 2012-06-20
• Results posted: 2012-06-20

Locations

83 sites across 12 countries: United States, Czechia, Denmark, Germany, Greece, Italy, Netherlands, Portugal, Russia, Spain, Sweden, United Kingdom