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Reno- and Vascular Protective Effect of a Vitamin-D-analogue in Moderate to Severe Chronic Kidney Disease

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. Identifier: NCT01136564
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : January 25, 2012
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro

Brief Summary:
Recently it has been documented that vitamin D has important functions in the human body that are unrelated to its primary effects in calcium homeostasis and bone mineralization. In clinical studies, paricalcitol - a low-calcemic vitamin D analogue - has been shown to decrease proteinuria, a marker of disease progression and cardiovascular risk in patients with chronic kidney disease (CKD). The purpose of this study is to investigate the effect of a paricalcitol on renal and cardiovascular variables in patients with moderate to severe CKD.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Zemplar Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reno- and Vascular Protective Effect of a Low-calcemic Vitamin-D-analogue (Paricalcitol) in Stage III-IV Chronic Kidney Disease
Study Start Date : July 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Paricalcitol Drug: Zemplar
2 capsules of 1 microgram daily

Placebo Comparator: Placebo Drug: Placebo
2 capsules daily

Primary Outcome Measures :
  1. plasma renin concentration [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Urinary albumin excretion [ Time Frame: 6 weeks ]
  2. GFR [ Time Frame: 6 weeks ]
  3. Fractional excretion of sodium [ Time Frame: 6 weeks ]
  4. Urinary excretion of aquaporin-2 [ Time Frame: 6 weeks ]
  5. Urinary excretion of ENaC-beta [ Time Frame: 6 weeks ]
  6. Urinary excretion of NCC [ Time Frame: 6 weeks ]
  7. Plasma concentration of aldosterone [ Time Frame: 6 weeks ]
  8. Plasma concentration of angiotensin-II [ Time Frame: 6 weeks ]
  9. Plasma concentration of ADH [ Time Frame: 6 weeks ]
  10. Plasma concentration of atrial natriuretic peptide [ Time Frame: 6 weeks ]
  11. Plasma concentration of brain natriuretic peptide [ Time Frame: 6 weeks ]
  12. Plasma concentration of endothelin [ Time Frame: 6 weeks ]
  13. 24-hr ambulatory blood pressure [ Time Frame: 6 weeks ]
  14. Central blood pressure [ Time Frame: 6 weeks ]
  15. Pulse wave velocity [ Time Frame: 6 weeks ]
  16. augmentation index [ Time Frame: 6 weeks ]
  17. Plasma concentration of ionized calcium [ Time Frame: 6 weeks ]
  18. Plasma concentration of phosphate [ Time Frame: 6 weeks ]
  19. Plasma concentration of alkaline phosphatase [ Time Frame: 6 weeks ]
  20. Plasma concentration of Parathyroid hormon [ Time Frame: 6 weeks ]
  21. Plasma concentration of 25-hydroxy-vitamin D [ Time Frame: 6 weeks ]
  22. Plasma concentration of ultrasensitive CRP [ Time Frame: 6 weeks ]
  23. Plasma concentration of TNF-alpha [ Time Frame: 6 weeks ]
  24. Plasma concentration of TGF-beta [ Time Frame: 6 weeks ]
  25. Urinary excretion of calcium [ Time Frame: 6 weeks ]
  26. Plasma concentration of ADMA [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Kidney disease corresponding to eGFR: 15-59 ml/min
  • Albuminuria > 30 mg/l

Exclusion Criteria:

  • Total parathyroidectomy
  • Diabetes Mellitus
  • Cancer
  • Illicit drug or alcohol abuse
  • Pregnancy og nursing
  • Ongoing NSAID or corticosteroid treatment
  • b-hemoglobin < 6 mmol/l
  • p-albumin < 25 mmol/l
  • Clinically significant hypercalcemia
  • Office blood pressure > 170/105 mmHg that despite antihypertensive treatment still is > 170/105 mmHg when using home blood pressure measurements or 24-hour ambulatory blood pressure measurement.

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 identifier (NCT number): NCT01136564

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Department of Medical Research
Holstebro, Denmark, 7500
Sponsors and Collaborators
Erling Bjerregaard Pedersen
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Principal Investigator: Erling B Pedersen, Prof, MSci Department of Medical Research
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Erling Bjerregaard Pedersen, Professor, MD, MSci, Regional Hospital Holstebro Identifier: NCT01136564    
Other Study ID Numbers: EBP-TL-2010
2009-017619-14 ( EudraCT Number )
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: January 25, 2012
Last Verified: January 2012
Keywords provided by Erling Bjerregaard Pedersen, Regional Hospital Holstebro:
vitamin d
kidney disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency