Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients

NCT ID: NCT01820767

Last Updated: 2018-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-03-31

Brief Summary

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

Detailed Description

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Use of Paricalcitol in stage Vd Chronic Kidney Disease patients using a permanent catheter due to haemodialysis; over the effect of inflammatory and oxidative stress parameters. This study uses paricalcitol (vitamin D) versus atorvastatin versus paricalcitol plus atorvastatin treatments.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Paricalcitol

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

Group Type EXPERIMENTAL

Paricalcitol

Intervention Type DRUG

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

Paricalcitol, Atorvastatin

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

Group Type ACTIVE_COMPARATOR

Paricalcitol, atorvastatin

Intervention Type DRUG

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.

Atorvastatin

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

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

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

Interventions

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Paricalcitol

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

Intervention Type DRUG

Paricalcitol, atorvastatin

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.

Intervention Type DRUG

Atorvastatin

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

Intervention Type DRUG

Other Intervention Names

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Group 1 G2 G3

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patients \> 18 years.
* Pregnant women.
* Patients hospitalized 4 weeks before the beginning of the treatment.
* Immunosuppressor intake.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ricardo Mouzo Mirco

OTHER

Sponsor Role lead

Responsible Party

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Ricardo Mouzo Mirco

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ricardo Mouzo Mirco, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital El Bierzo, Fuentesnuevas Ponferrada

Locations

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Hospital El Bierzo. Servicio de Nefrología.

Ponferrada, (León)., Spain

Site Status

Hospital de León

León, , Spain

Site Status

Countries

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Spain

Other Identifiers

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SENPARIC-2011-01

Identifier Type: -

Identifier Source: org_study_id

NCT02210533

Identifier Type: -

Identifier Source: nct_alias

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