Clinical trial NCT01820767: Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients
Official title: Paricalcitol Action on Parameters of Inflammation and Oxidative Stress in Patients With Chronic Kidney Disease Stage Vd Carriers Tunneled Hemodialysis Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Vd-stadium.
Inflammatory patterns
Paricalcitol
Atorvastatin
Lead sponsor: Hospital El Bierzo
Sponsor class: OTHER
First posted: 2013-03-29
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment wiht visits and analysis
measure: Oxidative stress and inflammative parameters
timeFrame: 12 weeks of treatment
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
measure: Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
timeFrame: 12 weeks of treatment with visits and analysis
Secondary outcomes:
measure: Nutritional Parameters
timeFrame: 12 weeks of treatment with visits and analysis
measure: Erythropoietin requirements variations
timeFrame: 12 weeks of treatment with visits and analysis
measure: Assess potential benefits inflammatory markers
timeFrame: 12 weeks of treatment with visits and analysis
measure: Nutritional Parameters
timeFrame: 12 weeks of treatment with visits and analysis
measure: Nutritional Parameters
timeFrame: 12 weeks of treatment with visits and analysis
measure: Nutritional Parameters
timeFrame: 12 weeks of treatment with visits and analysis
measure: Nutritional Parameters
timeFrame: 12 weeks of treatment with visits and analysis
measure: Nutritional Parameters
timeFrame: 12 weeks of treatment with visits and analysis
measure: Anaemia parameters
timeFrame: 12 weeks of treatment
measure: Anaemia Parameters
timeFrame: 12 weeks of treatment
measure: Erythropoietin requirement variations
timeFrame: 12 weeks of treatment with visits and analysis
measure: Erythropoietin requirement variations
timeFrame: 12 weeks of treatment with visits and analysis
measure: Erythropoietin requirements variations
timeFrame: 12 weeks of treatment with visits and analysis
measure: Erythropoietin requirements variations
timeFrame: 12 weeks of treatment with visits and analysis
measure: Assess potential benefits in inflammatory markers
timeFrame: 16 weeks, the complete duration of the study
Other outcomes:
Locations:
city: Ponferrada
country: Spain
facility: Hospital El Bierzo. Servicio de Nefrología.
state: (León).
city: León
country: Spain
facility: Hospital de León
Study officials:
affiliation: Hospital El Bierzo, Fuentesnuevas Ponferrada
name: Ricardo Mouzo Mirco, MD
role: PRINCIPAL_INVESTIGATOR
References: