Trial | NCT01820767  Report issue

Title

Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients
Paricalcitol Action on Parameters of Inflammation and Oxidative Stress in Patients With Chronic Kidney Disease Stage Vd Carriers Tunneled Hemodialysis Catheters

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    31
Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of inflammatory and oxidative stress parameters.
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.
Study Started
Aug 31
2012
Primary Completion
Oct 31
2013
Study Completion
Mar 31
2014
Last Update
Aug 24
2018

Drug Paricalcitol

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

  • Other names: Group 1

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.

  • Other names: G2

Drug Atorvastatin

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

  • Other names: G3

Paricalcitol Experimental

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

Paricalcitol, Atorvastatin Active Comparator

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

Atorvastatin Active Comparator

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

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.
No Results Posted