Paricalcitol Action on Parameters of Inflammation and Oxidative Stress in Patients With Chronic Kidney Disease Stage Vd Carriers Tunneled Hemodialysis Catheters
Overview
- Phase
- Phase 3
- Intervention
- Paricalcitol
- Conditions
- Chronic Kidney Disease
- Sponsor
- Ricardo Mouzo Mirco
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Ricardo Mouzo Mirco
MD
Hospital El Bierzo
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.
Arms & Interventions
Paricalcitol
SUBGROUP 1 (G1): Paricalcitol oral dosis triphosphoinositide mgc/100, 3 days a week.
Intervention: Paricalcitol
Paricalcitol, Atorvastatin
SUBGROUP 2 (G2): Paricalcitol (same dosis than G1) + Atorvastatin (1 daily dosis 20 mg)
Intervention: Paricalcitol, atorvastatin
Atorvastatin
SUBGROUP 3 (G3): Atorvastatin (same G2 dosis)
Intervention: Atorvastatin
Outcomes
Primary Outcomes
Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment
Time Frame: 12 weeks of treatment wiht visits and analysis
Measure parameter: IL-2
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time Frame: 12 weeks of treatment with visits and analysis
FGF-23
Oxidative stress and inflammative parameters
Time Frame: 12 weeks of treatment
Measure unit: IL-4
Secondary Outcomes
- Anaemia parameters(12 weeks of treatment)
- Anaemia Parameters(12 weeks of treatment)
- Nutritional Parameters(12 weeks of treatment with visits and analysis)
- Erythropoietin requirements variations(12 weeks of treatment with visits and analysis)
- Erythropoietin requirement variations(12 weeks of treatment with visits and analysis)
- Assess potential benefits inflammatory markers(12 weeks of treatment with visits and analysis)
- Assess potential benefits in inflammatory markers(16 weeks, the complete duration of the study)