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Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.

NCT01939977 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2018-11-19

Study results available
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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.

Conditions

  • Secondary Hyperparathyroidism Due to Renal Causes

Interventions

DRUG

Paricalcitol

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.

DRUG

Calcifediol

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.

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Effice Servicios Para la Investigacion S.L.

    collaborator INDUSTRY

  • Fundación Senefro

    lead OTHER

Principal Investigators

  • Josep M Cruzado, Dr · Fundación SENEFRO - Hospital Universitario de Bellvitge - Barcelona.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-09-30
Completion
2015-12-31

Countries

  • Spain

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01939977 on ClinicalTrials.gov