CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 148 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.

Search/NCT01939977
NCT01939977Phase 4Completed
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Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Renal Transplantation.

Fundación Senefro·interventional·Posted Sep 11, 2013·Updated Nov 19, 2018

In Brief

A Phase 4 clinical trial evaluating Paricalcitol and Calcifediol for Secondary Hyperparathyroidism Due to Renal Causes. Completed, enrolled 148 participants across 16 sites.

Detailed Summary

To demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hyperparathyroidism Due to Renal Causes
CountriesSpain
CollaboratorsAbbVie, Effice Servicios Para la Investigacion S.L.

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 11, 2013
Enrollment StartJan 1, 2014
Primary CompletionSep 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.8 years ago

Interventions

Paricalcitoldrug

1 capsule/day for 6 months. On Month 1 and Month 3 it can be increased up to 2 capsules/day or decreased down to 1 capsule/48 hours.

Calcifedioldrug

5 drops/day during 6 months. On Month 1 it can be increased up to 7 drops/day. If this occurs then, on Month 3, it can decreased to 5 drops/day or continue 7 drops/day until end of treatment.