SENPARIC: Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients

Sponsor

Ricardo Mouzo Mirco (Other)

Overall Status

Completed

CT.gov ID

NCT01820767

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

15.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of inflammatory and oxidative stress parameters.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Drug: Paricalcitol Drug: Paricalcitol, atorvastatin Drug: Atorvastatin	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Paricalcitol

SUBGROUP 1 (G1): Paricalcitol oral dosis triphosphoinositide mgc/100, 3 days a week.

Drug: Paricalcitol

Oral Paricalcitol. parathyroid hormone i mcg/100. 3 days per week, the same day as haemodialysis is done, during 12 weeks.

Other Names:

Group 1

Active Comparator: Paricalcitol, Atorvastatin

SUBGROUP 2 (G2): Paricalcitol (same dosis than G1) + Atorvastatin (1 daily dosis 20 mg)

Drug: 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.

Other Names:

Active Comparator: Atorvastatin

SUBGROUP 3 (G3): Atorvastatin (same G2 dosis)

Drug: Atorvastatin

Atorvastatin: 20 mg/day oral (1 take) during 12 weeks

Other Names:

Outcome Measures

Primary Outcome Measures

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
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-6
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-10
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-13
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]
TNF-beta
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]
CD3
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]
CD4
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]
CD8
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]
CD19
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]
CD25
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]
CD56
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]
CD69
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]
CD95
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]
COX-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]
iNOS
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]
PGE2
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.