Chronic Kidney Disease
Conditions
Keywords
Chronic Kidney Disease, Vd-stadium., Inflammatory patterns, Paricalcitol, Atorvastatin
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.
Interventions
DRUGParicalcitol
Oral Paricalcitol. parathyroid hormone i mcg/100. 3 days per week, the same day as haemodialysis is done, during 12 weeks.
DRUGParicalcitol, 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.
DRUGAtorvastatin
Atorvastatin: 20 mg/day oral (1 take) during 12 weeks
Sponsors
Ricardo Mouzo Mirco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment | 12 weeks of treatment wiht visits and analysis | Measure parameter: IL-2 |
| Oxidative stress and inflammative parameters | 12 weeks of treatment | Measure unit: IL-4 |
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | 12 weeks of treatment with visits and analysis | IL-5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anaemia parameters | 12 weeks of treatment | Hemogram |
| Anaemia Parameters | 12 weeks of treatment | Biochemistry |
| Nutritional Parameters | 12 weeks of treatment with visits and analysis | Weight |
| Assess potential benefits in inflammatory markers | 16 weeks, the complete duration of the study | Kt |
| Erythropoietin requirement variations | 12 weeks of treatment with visits and analysis | Ferritin |
| Erythropoietin requirements variations | 12 weeks of treatment with visits and analysis | Fe |
| Assess potential benefits inflammatory markers | 12 weeks of treatment with visits and analysis | PTHi |
Countries
Spain
Outcome results
None listed