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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01136564
First Posted: June 3, 2010
Last Update Posted: January 25, 2012
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.
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Holstebro Hospital
  Purpose
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 Intervention Phase
Chronic Kidney Disease Drug: Zemplar Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Erling Bjerregaard Pedersen, Holstebro Hospital:

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

Secondary Outcome Measures:
  • Urinary albumin excretion [ Time Frame: 6 weeks ]
  • GFR [ Time Frame: 6 weeks ]
  • Fractional excretion of sodium [ Time Frame: 6 weeks ]
  • Urinary excretion of aquaporin-2 [ Time Frame: 6 weeks ]
  • Urinary excretion of ENaC-beta [ Time Frame: 6 weeks ]
  • Urinary excretion of NCC [ Time Frame: 6 weeks ]
  • Plasma concentration of aldosterone [ Time Frame: 6 weeks ]
  • Plasma concentration of angiotensin-II [ Time Frame: 6 weeks ]
  • Plasma concentration of ADH [ Time Frame: 6 weeks ]
  • Plasma concentration of atrial natriuretic peptide [ Time Frame: 6 weeks ]
  • Plasma concentration of brain natriuretic peptide [ Time Frame: 6 weeks ]
  • Plasma concentration of endothelin [ Time Frame: 6 weeks ]
  • 24-hr ambulatory blood pressure [ Time Frame: 6 weeks ]
  • Central blood pressure [ Time Frame: 6 weeks ]
  • Pulse wave velocity [ Time Frame: 6 weeks ]
  • augmentation index [ Time Frame: 6 weeks ]
  • Plasma concentration of ionized calcium [ Time Frame: 6 weeks ]
  • Plasma concentration of phosphate [ Time Frame: 6 weeks ]
  • Plasma concentration of alkaline phosphatase [ Time Frame: 6 weeks ]
  • Plasma concentration of Parathyroid hormon [ Time Frame: 6 weeks ]
  • Plasma concentration of 25-hydroxy-vitamin D [ Time Frame: 6 weeks ]
  • Plasma concentration of ultrasensitive CRP [ Time Frame: 6 weeks ]
  • Plasma concentration of TNF-alpha [ Time Frame: 6 weeks ]
  • Plasma concentration of TGF-beta [ Time Frame: 6 weeks ]
  • Urinary excretion of calcium [ Time Frame: 6 weeks ]
  • Plasma concentration of ADMA [ Time Frame: 6 weeks ]

Enrollment: 30
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paricalcitol Drug: Zemplar
2 capsules of 1 microgram daily
Placebo Comparator: Placebo Drug: Placebo
2 capsules daily

  Eligibility

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

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.
  Contacts and Locations
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): NCT01136564


Locations
Denmark
Department of Medical Research
Holstebro, Denmark, 7500
Sponsors and Collaborators
Erling Bjerregaard Pedersen
Investigators
Principal Investigator: Erling B Pedersen, Prof, MSci Department of Medical Research
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erling Bjerregaard Pedersen, Professor, MD, MSci, Holstebro Hospital
ClinicalTrials.gov Identifier: NCT01136564     History of Changes
Other Study ID Numbers: EBP-TL-2010
2009-017619-14 ( EudraCT Number )
First Submitted: June 2, 2010
First Posted: June 3, 2010
Last Update Posted: January 25, 2012
Last Verified: January 2012

Keywords provided by Erling Bjerregaard Pedersen, Holstebro Hospital:
paricalcitol
vitamin d
kidney disease
renin
proteinuria

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents