Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients

Phase 3

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Paricalcitol, atorvastatin; Drug: Paricalcitol; Drug: Atorvastatin

• Registration Number: NCT01820767
• Lead Sponsor: Ricardo Mouzo Mirco

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-29
• Primary Completion: 2013-10
• Study Completion: 2014-03
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paricalcitol, Atorvastatin	Paricalcitol, atorvastatin	SUBGROUP 2 (G2): Paricalcitol (same dosis than G1) + Atorvastatin (1 daily dosis 20 mg)
Paricalcitol	Paricalcitol	SUBGROUP 1 (G1): Paricalcitol oral dosis triphosphoinositide mgc/100, 3 days a week.
Atorvastatin	Atorvastatin	SUBGROUP 3 (G3): Atorvastatin (same G2 dosis)

Primary Outcome Measures

Name	Time	Method
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 in patients with CKD stage vitamin D after 12 weeks of treatment	12 weeks of treatment with visits and analysis	FGF-23
Oxidative stress and inflammative parameters	12 weeks of treatment	Measure unit: IL-4

Secondary Outcome Measures

Name	Time	Method
Anaemia parameters	12 weeks of treatment	Hemogram
Anaemia Parameters	12 weeks of treatment	Biochemistry
Nutritional Parameters	12 weeks of treatment with visits and analysis	Bioimpedance
Erythropoietin requirements variations	12 weeks of treatment with visits and analysis	Folic Acid
Erythropoietin requirement variations	12 weeks of treatment with visits and analysis	Transferrin saturation index
Assess potential benefits inflammatory markers	12 weeks of treatment with visits and analysis	PTHi
Assess potential benefits in inflammatory markers	16 weeks, the complete duration of the study	Kt

Trial Locations

Locations (2)

Hospital El Bierzo. Servicio de Nefrología.; 🇪🇸 Ponferrada, (León)., Spain

Hospital de León; 🇪🇸 León, Spain