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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Holstebro Hospital
ClinicalTrials.gov Identifier:
NCT01136564
First received: June 2, 2010
Last updated: January 24, 2012
Last verified: January 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 Regional Hospital Holstebro:

Primary Outcome Measures:
  • plasma renin concentration [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary albumin excretion [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • GFR [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Fractional excretion of sodium [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Urinary excretion of aquaporin-2 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Urinary excretion of ENaC-beta [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Urinary excretion of NCC [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of aldosterone [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of angiotensin-II [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of ADH [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of atrial natriuretic peptide [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of brain natriuretic peptide [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of endothelin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 24-hr ambulatory blood pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Central blood pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Pulse wave velocity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • augmentation index [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of ionized calcium [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Plasma concentration of phosphate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of alkaline phosphatase [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of Parathyroid hormon [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of 25-hydroxy-vitamin D [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of ultrasensitive CRP [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of TNF-alpha [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of TGF-beta [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Urinary excretion of calcium [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of ADMA [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 2, 2010
Last Updated: January 24, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Regional Hospital Holstebro:
paricalcitol
vitamin d
kidney disease
renin
proteinuria

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

ClinicalTrials.gov processed this record on April 22, 2014