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Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients (SENPARIC)

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Paricalcitol
Paricalcitol, atorvastatin
Atorvastatin
Sponsored by
Ricardo Mouzo Mirco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Vd-stadium., Inflammatory patterns, Paricalcitol, Atorvastatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Exclusion Criteria:

  • Patients > 18 years.
  • Pregnant women.
  • Patients hospitalized 4 weeks before the beginning of the treatment.
  • Immunosuppressor intake.

Sites / Locations

  • Hospital El Bierzo. Servicio de Nefrología.
  • Hospital de León

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Paricalcitol

Paricalcitol, Atorvastatin

Atorvastatin

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Nutritional Parameters
Weight
Erythropoietin requirements variations
Fe
Assess potential benefits inflammatory markers
PTHi
Nutritional Parameters
Height
Nutritional Parameters
Body Mass Index (BMI)
Nutritional Parameters
Abdominal circumference
Nutritional Parameters
Triceps skin fold circumference
Nutritional Parameters
Bioimpedance
Anaemia parameters
Hemogram
Anaemia Parameters
Biochemistry
Erythropoietin requirement variations
Ferritin
Erythropoietin requirement variations
Transferrin saturation index
Erythropoietin requirements variations
B12
Erythropoietin requirements variations
Folic Acid
Assess potential benefits in inflammatory markers
Kt

Full Information

First Posted
March 19, 2013
Last Updated
August 22, 2018
Sponsor
Ricardo Mouzo Mirco
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1. Study Identification

Unique Protocol Identification Number
NCT01820767
Brief Title
Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients
Acronym
SENPARIC
Official Title
Paricalcitol Action on Parameters of Inflammation and Oxidative Stress in Patients With Chronic Kidney Disease Stage Vd Carriers Tunneled Hemodialysis Catheters
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ricardo Mouzo Mirco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic Kidney Disease, Vd-stadium., Inflammatory patterns, Paricalcitol, Atorvastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paricalcitol
Arm Type
Experimental
Arm Description
SUBGROUP 1 (G1): Paricalcitol oral dosis triphosphoinositide mgc/100, 3 days a week.
Arm Title
Paricalcitol, Atorvastatin
Arm Type
Active Comparator
Arm Description
SUBGROUP 2 (G2): Paricalcitol (same dosis than G1) + Atorvastatin (1 daily dosis 20 mg)
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
SUBGROUP 3 (G3): Atorvastatin (same G2 dosis)
Intervention Type
Drug
Intervention Name(s)
Paricalcitol
Other Intervention Name(s)
Group 1
Intervention Description
Oral Paricalcitol. parathyroid hormone i mcg/100. 3 days per week, the same day as haemodialysis is done, during 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Paricalcitol, atorvastatin
Other Intervention Name(s)
G2
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
G3
Intervention Description
Atorvastatin: 20 mg/day oral (1 take) during 12 weeks
Primary Outcome Measure Information:
Title
Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment
Description
Measure parameter: IL-2
Time Frame
12 weeks of treatment wiht visits and analysis
Title
Oxidative stress and inflammative parameters
Description
Measure unit: IL-4
Time Frame
12 weeks of treatment
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
IL-5
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
IL-6
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
IL-10
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
IL-13
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
TNF-beta
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
CD3
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
CD4
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
CD8
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
CD19
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
CD25
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
CD56
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
CD69
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
CD95
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
COX-2
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
iNOS
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
PGE2
Time Frame
12 weeks of treatment with visits and analysis
Title
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Description
FGF-23
Time Frame
12 weeks of treatment with visits and analysis
Secondary Outcome Measure Information:
Title
Nutritional Parameters
Description
Weight
Time Frame
12 weeks of treatment with visits and analysis
Title
Erythropoietin requirements variations
Description
Fe
Time Frame
12 weeks of treatment with visits and analysis
Title
Assess potential benefits inflammatory markers
Description
PTHi
Time Frame
12 weeks of treatment with visits and analysis
Title
Nutritional Parameters
Description
Height
Time Frame
12 weeks of treatment with visits and analysis
Title
Nutritional Parameters
Description
Body Mass Index (BMI)
Time Frame
12 weeks of treatment with visits and analysis
Title
Nutritional Parameters
Description
Abdominal circumference
Time Frame
12 weeks of treatment with visits and analysis
Title
Nutritional Parameters
Description
Triceps skin fold circumference
Time Frame
12 weeks of treatment with visits and analysis
Title
Nutritional Parameters
Description
Bioimpedance
Time Frame
12 weeks of treatment with visits and analysis
Title
Anaemia parameters
Description
Hemogram
Time Frame
12 weeks of treatment
Title
Anaemia Parameters
Description
Biochemistry
Time Frame
12 weeks of treatment
Title
Erythropoietin requirement variations
Description
Ferritin
Time Frame
12 weeks of treatment with visits and analysis
Title
Erythropoietin requirement variations
Description
Transferrin saturation index
Time Frame
12 weeks of treatment with visits and analysis
Title
Erythropoietin requirements variations
Description
B12
Time Frame
12 weeks of treatment with visits and analysis
Title
Erythropoietin requirements variations
Description
Folic Acid
Time Frame
12 weeks of treatment with visits and analysis
Title
Assess potential benefits in inflammatory markers
Description
Kt
Time Frame
16 weeks, the complete duration of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Mouzo Mirco, MD
Organizational Affiliation
Hospital El Bierzo, Fuentesnuevas Ponferrada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital El Bierzo. Servicio de Nefrología.
City
Ponferrada
State/Province
(León).
ZIP/Postal Code
24411,
Country
Spain
Facility Name
Hospital de León
City
León
ZIP/Postal Code
24008
Country
Spain

12. IPD Sharing Statement

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Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients

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