Effect of oral paricalcitol on endothelial function and FGF-23 in peritoneal dialysis patients: a pilot study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002744-24-IT

Enrollment

Registered

2012-10-11

Start date

2012-12-16

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHRONIC RENAL FAILURE MedDRA version: 14.1 Level: PT Classification code 10038444 Term: Renal failure chronic System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: ZEMPLAR*28CPS 1MCG Pharmaceutical Form: Capsule, soft INN or Proposed INN: PARICALCITOL CAS Number: 131918-61-1 Concentration unit: µg microgram(s) Concentration type: up to Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Thirty patients older than 18 under peritoneal dialysis (all modalities) since at least 3 months with secondary Hyperparathyroidism. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - poor medication compliance; - parathyroidectomy; lactation, pregnancy; treatment with cinacalcet.

Design outcomes

Primary

Measure	Time frame
Main Objective: Changes in post-ischemic brachial artery dilatation from baseline to sixth month. Changes in FGF-23 from baseline to sixth month.;Secondary Objective: Changes in FGF-23 from baseline to third month. changes in endothelial biomarkers (vWF, isoprostane F2t, pentraxina -3) baseline to third month.;Primary end point(s): Changes in post-ischemic brachial artery dilatation. Changes in FGF-23.;Timepoint(s) of evaluation of this end point: 6 months.	—

Measure

Time frame

Main Objective: Changes in post-ischemic brachial artery dilatation from baseline to sixth month. Changes in FGF-23 from baseline to sixth month.;Secondary Objective: Changes in FGF-23 from baseline to third month. changes in endothelial biomarkers (vWF, isoprostane F2t, pentraxina -3) baseline to third month.;Primary end point(s): Changes in post-ischemic brachial artery dilatation. Changes in FGF-23.;Timepoint(s) of evaluation of this end point: 6 months.

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in FGF-23 from changes in endothelial biomarkers (vWF, isoprostane F2t, pentraxina -3);Timepoint(s) of evaluation of this end point: 3 months.	—

Countries

Italy

Contacts

Public Contactnefrologia

Policlinico Gemelli

giovanni.gambaro@rm.unicatt.it063503434

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026