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Completed

NCT Number: NCT01820767

Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients

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

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paricalcitol

Drug

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

Paricalcitol, atorvastatin

Drug

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

atorvastatin

Drug

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

Other names: G3

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ricardo Mouzo Mirco

Other

Registry information

Official study title

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

Acronym: SENPARIC

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Mar 29, 2013
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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