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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Urologic Diseases
Renal Insufficiency
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 31, 2014