Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients

Study Overview
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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.

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

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: Paricalcitol
* Drug: Paricalcitol, atorvastatin
* Drug: Atorvastatin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paricalcitol<br>SUBGROUP 1 (G1): Paricalcitol oral dosis triphosphoinositide mgc/100, 3 days a week. | Drug: Paricalcitol<br>* Oral Paricalcitol. parathyroid hormone i mcg/100. 3 days per week, the same day as haemodialysis is done, during 12 weeks.<br>* Other names: Group 1;|
| Active Comparator: Paricalcitol, Atorvastatin<br>SUBGROUP 2 (G2): Paricalcitol (same dosis than G1) + Atorvastatin (1 daily dosis 20 mg) | Drug: Paricalcitol, atorvastatin<br>* 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.<br>* Other names: G2;|
| Active Comparator: Atorvastatin<br>SUBGROUP 3 (G3): Atorvastatin (same G2 dosis) | Drug: Atorvastatin<br>* Atorvastatin: 20 mg/day oral (1 take) during 12 weeks<br>* Other names: G3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment | Measure parameter: IL-2 | 12 weeks of treatment wiht visits and analysis | 
| Oxidative stress and inflammative parameters | Measure unit: IL-4 | 12 weeks of treatment | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | IL-5 | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | IL-6 | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | IL-10 | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | IL-13 | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | TNF-beta | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD3 | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD4 | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD8 | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD19 | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD25 | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD56 | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD69 | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | CD95 | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | COX-2 | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | iNOS | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | PGE2 | 12 weeks of treatment with visits and analysis | 
| Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment | FGF-23 | 12 weeks of treatment with visits and analysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional Parameters | Weight | 12 weeks of treatment with visits and analysis | 
| Erythropoietin requirements variations | Fe | 12 weeks of treatment with visits and analysis | 
| Assess potential benefits inflammatory markers | PTHi | 12 weeks of treatment with visits and analysis | 
| Nutritional Parameters | Height | 12 weeks of treatment with visits and analysis | 
| Nutritional Parameters | Body Mass Index (BMI) | 12 weeks of treatment with visits and analysis | 
| Nutritional Parameters | Abdominal circumference | 12 weeks of treatment with visits and analysis | 
| Nutritional Parameters | Triceps skin fold circumference | 12 weeks of treatment with visits and analysis | 
| Nutritional Parameters | Bioimpedance | 12 weeks of treatment with visits and analysis | 
| Anaemia parameters | Hemogram | 12 weeks of treatment | 
| Anaemia Parameters | Biochemistry | 12 weeks of treatment | 
| Erythropoietin requirement variations | Ferritin | 12 weeks of treatment with visits and analysis | 
| Erythropoietin requirement variations | Transferrin saturation index | 12 weeks of treatment with visits and analysis | 
| Erythropoietin requirements variations | B12 | 12 weeks of treatment with visits and analysis | 
| Erythropoietin requirements variations | Folic Acid | 12 weeks of treatment with visits and analysis | 
| Assess potential benefits in inflammatory markers | Kt | 16 weeks, the complete duration of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease, Vd-stadium., Inflammatory patterns, Paricalcitol, Atorvastatin