NCT01820767

Brief Summary

Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of inflammatory and oxidative stress parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

March 19, 2013

Last Update Submit

August 22, 2018

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney DiseaseVd-stadium.Inflammatory patternsParicalcitolAtorvastatin

Outcome Measures

Primary Outcomes (19)

  • Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment

    Measure parameter: IL-2

    12 weeks of treatment wiht visits and analysis

  • Oxidative stress and inflammative parameters

    Measure unit: IL-4

    12 weeks of treatment

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    IL-5

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    IL-6

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    IL-10

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    IL-13

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    TNF-beta

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    CD3

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    CD4

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    CD8

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    CD19

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    CD25

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    CD56

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    CD69

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    CD95

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    COX-2

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    iNOS

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    PGE2

    12 weeks of treatment with visits and analysis

  • Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment

    FGF-23

    12 weeks of treatment with visits and analysis

Secondary Outcomes (15)

  • Nutritional Parameters

    12 weeks of treatment with visits and analysis

  • Erythropoietin requirements variations

    12 weeks of treatment with visits and analysis

  • Assess potential benefits inflammatory markers

    12 weeks of treatment with visits and analysis

  • Nutritional Parameters

    12 weeks of treatment with visits and analysis

  • Nutritional Parameters

    12 weeks of treatment with visits and analysis

  • +10 more secondary outcomes

Study Arms (3)

Paricalcitol

EXPERIMENTAL

SUBGROUP 1 (G1): Paricalcitol oral dosis triphosphoinositide mgc/100, 3 days a week.

Drug: Paricalcitol

Paricalcitol, Atorvastatin

ACTIVE COMPARATOR

SUBGROUP 2 (G2): Paricalcitol (same dosis than G1) + Atorvastatin (1 daily dosis 20 mg)

Drug: Paricalcitol, atorvastatin

Atorvastatin

ACTIVE COMPARATOR

SUBGROUP 3 (G3): Atorvastatin (same G2 dosis)

Drug: Atorvastatin

Interventions

ParicalcitolDRUG

Oral Paricalcitol. parathyroid hormone i mcg/100. 3 days per week, the same day as haemodialysis is done, during 12 weeks.

Also known as: Group 1
Paricalcitol
Paricalcitol, atorvastatinDRUG

Oral Paricalcitol. parathyroid hormone i mgc/100. 3 days a week, the same day as haemodialysis, during 12 weeks. Atorvastatin: 20 mg/day oral (1 take) during 12 weeks.

Also known as: G2
Paricalcitol, Atorvastatin
AtorvastatinDRUG

Atorvastatin: 20 mg/day oral (1 take) during 12 weeks

Also known as: G3
Atorvastatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Vd CKD patients using haemodialysis during 3 or more months.
  • Tunnelized-bearer permanent catheters on haemodialysis at last 6 months previous at the beginning of the study. .
  • Kt stable, over 45 litres on both sexs.
  • Patients in treatment wiht atorvastatin
  • Patients without infectious or inflammatory processes over 8 weeks.
  • Two consecutive PTH \< than 400 pg/ml; Ca\<10.2 and P \<7.0 mg/dl.

You may not qualify if:

  • Patients \> 18 years.
  • Pregnant women.
  • Patients hospitalized 4 weeks before the beginning of the treatment.
  • Immunosuppressor intake.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital El Bierzo. Servicio de Nefrología.

Ponferrada, (León)., 24411,, Spain

Location

Hospital de León

León, 24008, Spain

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

paricalcitolAtorvastatin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Ricardo Mouzo Mirco, MD

    Hospital El Bierzo, Fuentesnuevas Ponferrada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 29, 2013

Study Start

August 1, 2012

Primary Completion

October 1, 2013

Study Completion

March 1, 2014

Last Updated

August 24, 2018

Record last verified: 2018-08

Locations

ES(2)