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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01820767
Recruitment Status : Completed
First Posted : March 29, 2013
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Ricardo Mouzo Mirco, Hospital El Bierzo

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.

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Study Type : Interventional  (Clinical Trial)
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 : August 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : March 2014


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 Name: 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 Name: G2

Active Comparator: Atorvastatin
SUBGROUP 3 (G3): Atorvastatin (same G2 dosis)
Drug: Atorvastatin
Atorvastatin: 20 mg/day oral (1 take) during 12 weeks
Other Name: G3




Primary Outcome Measures :
  1. Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment wiht visits and analysis ]
    Measure parameter: IL-2

  2. Oxidative stress and inflammative parameters [ Time Frame: 12 weeks of treatment ]
    Measure unit: IL-4

  3. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    IL-5

  4. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    IL-6

  5. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    IL-10

  6. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    IL-13

  7. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    TNF-beta

  8. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    CD3

  9. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    CD4

  10. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    CD8

  11. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    CD19

  12. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    CD25

  13. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    CD56

  14. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    CD69

  15. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    CD95

  16. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    COX-2

  17. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    iNOS

  18. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    PGE2

  19. Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment [ Time Frame: 12 weeks of treatment with visits and analysis ]
    FGF-23


Secondary Outcome Measures :
  1. Nutritional Parameters [ Time Frame: 12 weeks of treatment with visits and analysis ]
    Weight

  2. Erythropoietin requirements variations [ Time Frame: 12 weeks of treatment with visits and analysis ]
    Fe

  3. Assess potential benefits inflammatory markers [ Time Frame: 12 weeks of treatment with visits and analysis ]
    PTHi

  4. Nutritional Parameters [ Time Frame: 12 weeks of treatment with visits and analysis ]
    Height

  5. Nutritional Parameters [ Time Frame: 12 weeks of treatment with visits and analysis ]
    Body Mass Index (BMI)

  6. Nutritional Parameters [ Time Frame: 12 weeks of treatment with visits and analysis ]
    Abdominal circumference

  7. Nutritional Parameters [ Time Frame: 12 weeks of treatment with visits and analysis ]
    Triceps skin fold circumference

  8. Nutritional Parameters [ Time Frame: 12 weeks of treatment with visits and analysis ]
    Bioimpedance

  9. Anaemia parameters [ Time Frame: 12 weeks of treatment ]
    Hemogram

  10. Anaemia Parameters [ Time Frame: 12 weeks of treatment ]
    Biochemistry

  11. Erythropoietin requirement variations [ Time Frame: 12 weeks of treatment with visits and analysis ]
    Ferritin

  12. Erythropoietin requirement variations [ Time Frame: 12 weeks of treatment with visits and analysis ]
    Transferrin saturation index

  13. Erythropoietin requirements variations [ Time Frame: 12 weeks of treatment with visits and analysis ]
    B12

  14. Erythropoietin requirements variations [ Time Frame: 12 weeks of treatment with visits and analysis ]
    Folic Acid

  15. Assess potential benefits in inflammatory markers [ Time Frame: 16 weeks, the complete duration of the study ]
    Kt



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01820767


Locations
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Spain
Hospital El Bierzo. Servicio de Nefrología.
Ponferrada, (León)., Spain, 24411,
Hospital de León
León, Spain, 24008
Sponsors and Collaborators
Ricardo Mouzo Mirco
Investigators
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Principal Investigator: Ricardo Mouzo Mirco, MD Hospital El Bierzo, Fuentesnuevas Ponferrada
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Responsible Party: Ricardo Mouzo Mirco, MD, Hospital El Bierzo
ClinicalTrials.gov Identifier: NCT01820767    
Obsolete Identifiers: NCT02210533
Other Study ID Numbers: SENPARIC-2011-01
First Posted: March 29, 2013    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Keywords provided by Ricardo Mouzo Mirco, Hospital El Bierzo:
Chronic Kidney Disease
Vd-stadium.
Inflammatory patterns
Paricalcitol
Atorvastatin
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Ergocalciferols
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Bone Density Conservation Agents