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Clinical Trial Details

Trial ID: L0199
Source ID: NCT01820767
Associated Drug: Paricalcitol
Title: Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients
Acronym: SENPARIC
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: Paricalcitol|DRUG: Paricalcitol, atorvastatin|DRUG: Atorvastatin
Outcome Measures: Primary: 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: 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
Sponsor/Collaborators: Sponsor: Ricardo Mouzo Mirco
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 31
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2012-08
Completion Date: 2014-03
Results First Posted:
Last Update Posted: 2018-08-24
Locations: Hospital El Bierzo. Servicio de Nefrología., Ponferrada, (León)., 24411,, Spain|Hospital de León, León, 24008, Spain
URL: https://clinicaltrials.gov/show/NCT01820767