At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 272 enrolled
Drug / intervention
Paricalcitol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Paricalcitol and Cinacalcet for Chronic Kidney Disease and 2 related conditions. Completed, enrolled 272 participants across 83 sites in 12 countries.
Detailed Summary
Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia, Denmark, Germany, Greece, Italy, Netherlands, Portugal, Russia, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2009
Enrollment StartNov 2009
Primary CompletionMay 2011
TodayJul 2026
First PostedSep 15, 2009
Enrollment StartNov 1, 2009
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.8 years ago
Interventions
Paricalcitoldrug
Paricalcitol dosed per label by region (participants were to receive cinacalcet if they developed hypercalcemia)
Cinacalcetdrug
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)