Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients
NCT ID: NCT01820767
Last Updated: 2018-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
31 participants
INTERVENTIONAL
2012-08-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Paricalcitol
SUBGROUP 1 (G1): Paricalcitol oral dosis triphosphoinositide mgc/100, 3 days a week.
Paricalcitol
Oral Paricalcitol. parathyroid hormone i mcg/100. 3 days per week, the same day as haemodialysis is done, during 12 weeks.
Paricalcitol, Atorvastatin
SUBGROUP 2 (G2): Paricalcitol (same dosis than G1) + Atorvastatin (1 daily dosis 20 mg)
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.
Atorvastatin
SUBGROUP 3 (G3): Atorvastatin (same G2 dosis)
Atorvastatin
Atorvastatin: 20 mg/day oral (1 take) during 12 weeks
Interventions
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Paricalcitol
Oral Paricalcitol. parathyroid hormone i mcg/100. 3 days per week, the same day as haemodialysis is done, during 12 weeks.
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.
Atorvastatin
Atorvastatin: 20 mg/day oral (1 take) during 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant women.
* Patients hospitalized 4 weeks before the beginning of the treatment.
* Immunosuppressor intake.
18 Years
ALL
No
Sponsors
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Ricardo Mouzo Mirco
OTHER
Responsible Party
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Ricardo Mouzo Mirco
MD
Principal Investigators
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Ricardo Mouzo Mirco, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital El Bierzo, Fuentesnuevas Ponferrada
Locations
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Hospital El Bierzo. Servicio de Nefrología.
Ponferrada, (León)., Spain
Hospital de León
León, , Spain
Countries
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Other Identifiers
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SENPARIC-2011-01
Identifier Type: -
Identifier Source: org_study_id
NCT02210533
Identifier Type: -
Identifier Source: nct_alias
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